Let’s take a moment for a thought experiment. I do this days after more Palestinian attacks on Israelis, including the horrific murder of a mother of six children; soon after Israel announced the expropriation of another 370 acres of land near Jericho; and after Majed Faraj, the Palestinian security chief, announced that Palestinian security forces had intercepted 200 potential terrorist attacks against Israel. The thought experiment focuses on whether the “Plan B” for the Israel-Palestine dispute should be Israel’s annexation of the territories it occupied in 1967 and the extension of full citizenship rights to the Palestinians in those areas.

To be sure, I still count myself among the dying breed of those who believe fervently in the two-state solution—two states living side by side in peace and security, each enjoying sovereignty and political independence in part of the land that both claim as their exclusive national homes. This is still the best, by far, of all possible outcomes of the dispute. This is not to say that the two-state solution is without faults. Thus far, the two sides have not been able to agree on critical details, and there is no guarantee that achieving two states would assure peaceful relations. But the two-state solution, based on partition of the land, appears to offer the best chance for long term peace. I would dump all Plan B’s and C’s in a heartbeat if leadership emerged in Israel and Palestine—and in the United States—that proved willing to move toward a two-state outcome. 

I still count myself among the dying breed of those who believe fervently in the two-state solution.

But hoping for better, stronger, more farsighted leadership is not a substitute for policy. The fact is that both Israel and the Palestine Liberation Organization (PLO) are further today from bringing forth such leaders than at any time before. Even if Benjamin Netanyahu yields the prime minister’s office to another contender, no one in Israel is proposing the kind of far-reaching accommodation toward which Ehud Olmert was heading in 2008. None of Mahmoud Abbas’s likely successors has even articulated a reasonable peace plan. And none of the candidates for U.S. president is likely to be as committed to the search for peace as Barack Obama has been, and even his commitment has fallen far short of what is needed to move the recalcitrant parties toward peace. The sad reality is that politics—not policy, per se—is what blocks progress toward a two-state solution.

The sad reality is that politics—not policy, per se—is what blocks progress toward a two-state solution.

Regional solution?

In the absence of progress toward two states, are there better alternatives than throwing in the towel and looking at annexation as Plan B? The search for alternative Plan B’s is a fool’s errand. Some of those ideas are creative, but none of them will be accepted by both sides. For example, one Plan B variant du jour rests on the premise of a “regional solution”—that is, having Israel and the Arab world reach a comprehensive peace agreement that includes a resolution of the Palestinian issue. Sounds good, except it makes no sense. 

First, Israel has not accepted the Arab Peace Initiative (API) of 2002, the closest the Arab world has come to accepting Israel within the borders of the 1949 armistice line and agreeing to normalize relations with Israel once peace has been achieved. But no Israeli government has liked its terms, especially the paragraph on Palestinian refugees, the notion of a Palestinian capital in Jerusalem, and the API’s insistence on full Israeli withdrawal. Thus, the question to those who propose a regional solution today is whether there is a coalition in Israel ready to use the API as the basis for negotiating a comprehensive peace. I think not.

Second, the Arab world is in no position to deliver on what the API promises. The Arabs have never followed up the API by engaging Israel. And the premise of the API has been that the Arabs will recognize Israel and agree to normalize only after peace is concluded with the Palestinians (and the Syrians and Lebanese)– not a very attractive incentive for Israelis to enter a risky peace process.

[T]he Arab world of 2002, however dysfunctional, was far more stable than the Arab world of 2016.

And third, the Arab world of 2002, however dysfunctional, was far more stable than the Arab world of 2016. The opponents of the two-state solution in Israel point to this when describing the security dangers that Israel would face were it to concede anything now to the Palestinians. Even if a comprehensive solution were to rest on the shoulders of Egypt and Jordan, Israel’s peace treaty partners, would Israeli skeptics truly be assuaged that these countries could assure Israel’s security in the face of continued instability (Egypt) or the impact of refugees and economic distress (Jordan)? Indeed, the idea of a regional or comprehensive solution based on Arab stability today is chimerical. 

Status quo?

The alternatives to the regional idea are equally unrealistic. The idea of confederation rests on the agreement of Jordan (and potentially Egypt) to join a political entity with the Palestinians. However, neither state has indicated any interest in doing so. 

“Maintaining the status quo” is a non-starter, because status quos are never static—as the events of recent years prove, they tend to get worse. How many Intifadas or stabbings will it take for the people of Israel to believe their own security chiefs, who recognize that these actions are born of frustration over the occupation and related grievances? Why should Israelis believe that the majority of Palestinians are interested in peace when Hamas—opposed to Israel’s very existence—still rules Gaza and commands significant popular support, and while the Palestinian Authority is crumbling and hardly represents anyone anymore? And how long will it take Palestinian supporters of armed and violent resistance to recognize that their abortive efforts to destroy Israel and indiscriminate attacks on Israeli civilians are repugnant: targeting civilians is a morally unacceptable tactic for any resistance movement. 

Thus, the idea of “conflict management” or even “conflict mitigation”—staple products of those who support maintaining the status quo until somehow things change—is pernicious, for it rests on an assumption that the rest of us simply don’t understand the conflict.

[T]he idea of a regional or comprehensive solution based on Arab stability today is chimerical.

A futile search for alternatives

And so it is for all other Plan B’s. Several years ago, my Princeton graduate students embarked on an effort to find a viable alternative to the two-state solution; and they told me at the outset that they intended to prove that such an alternative existed. In the end, they failed and returned to the idea that the only viable solution was to partition the land into two states. Others, too, have tried to find alternatives, and some retain the hope that their policy proposal might win the day. I wish them well—for I really do believe in peace, whether it’s via two states or otherwise. But I have no confidence they will succeed.

[T]he idea of “conflict management” or even “conflict mitigation”—staple products of those who support maintaining the status quo until somehow things change—is pernicious, for it rests on an assumption that the rest of us simply don’t understand the conflict.

And so we are back to the thought experiment. This would take as a starting point what Israeli Minister Uri Ariel told my students several years ago: we (Israel) have won, and the land of Israel is ours. Under this scenario, Israel would:

• Formally annex the territories it occupied in 1967, basing its legal argument on its belief that these are “disputed” rather than “occupied” territories. 
• In connection with this act of annexation, Israel would offer full citizenship rights to all the Palestinians living in the territories. While Israel would probably want to include only the West Bank in this arrangement, excluding Gaza would make it impossible to secure any support internationally, in that Gaza is as much a part of Resolution 242 as is the West Bank.
• Those Palestinians who accept citizenship would then enjoy equal rights with all other Israelis; those Palestinians who reject citizenship would be offered permanent residency, a status that would include certain rights and privileges but not full citizenship rights (for example, voting in national elections). 
• Israel would then approach the United Nations Security Council to argue that these measures constituted an act of self-determination, and that the outcome represented an end of the conflict in accordance with Resolution 242. I am not a lawyer and I assume that many—including Palestinians and Arabs—would dispute this Israeli argument. But the process would change the status quo fundamentally and offer a real alternative to the two-state solution.

Could this work, and is it a real Plan B for the conflict? This is but a thought experiment. I suppose most Israelis will hate this idea for it exposes the most significant weakness of the Israeli right wing and the settlements movement, namely that it undercuts fundamentally the idea of a permanent Jewish majority state. Similarly, most Palestinians will also hate this idea because it forecloses the possibility of a real act of self-determination culminating in an independent state and forces Palestinians to confront the emptiness of the slogans that their leaders have employed over the years in the context of the Arab-Israeli dispute. 

The thought experiment is thus not very sound. Perhaps, then, it will scare everyone enough for leaders to get serious about peace.

The composition and track record of the current Israeli government leads Palestinians to expect very little from Israel in the way of advancing peace. After five decades of military occupation, and repeated failures of two decades of bilateral negotiations based on the Oslo Accords, there is a clear need for new ideas. But the proposals offered by Amos Yadlin’s post last month, “Two states, four paths for achieving them,” do not accord with basic realities on the Palestinian side, and as such do not offer a viable pathway to a two-state outcome.

Yadlin’s argument is premised on the belief that a negotiated two-state outcome is not possible today because of a Palestinian refusal to engage. He argues: “It appears that in 2016, the Palestinians do not view a two-state solution…as a preferred outcome.” Palestinians, by contrast, see their leaders’ actions, like the November 2012 UN General Assembly resolution that accorded Palestine observer state status, as efforts to save the two-state solution in the face of Israeli actions that undermine it.

The outcome Yadlin offers as one that would meet Israel’s needs would require Palestinians to forfeit basic components of statehood and basic principles of Israeli-Palestinian peace that are enshrined in international law, such as the right for Palestinian refugees to return to their or their families’ places of origin in what is today Israel. 

Similarly, Yadlin calls for Palestinians to accept “limitations on their sovereignty” to meet Israeli security concerns. From a Palestinian perspective, though, that sovereignty has been systematically constrained already by Israeli policies, including annexation of territory and the expanding settlement enterprise. These are but two examples of divergent viewpoints between Israelis and Palestinians that doom each of the “four paths” Mr. Yadlin proposes to reach a two-state solution. 

Each of Yadlin’s proposed paths for Israel—negotiations toward a final status agreement (with the expectation that they would fail due to Palestinian intransigence), pursuing a regional agreement, seeking an interim bilateral agreement, and taking unilateral action—is problematic.

“A negotiation process resulting in a final status agreement” – The Oslo Peace Accords and the 20 years of unconsummated negotiations that followed were an intensive effort to achieve just that. However, they failed in part because they did not address the fundamental asymmetry between the parties to those accords—Palestinians recognized a state, and Israel, in turn, recognized the representative body of a national movement seeking its right to self-determination. 

If Israelis were serious about two states, and heeded lessons from the failed interim agreements of the Oslo process, a good starting point would be for Israel to reciprocate the political recognition of Israel that the Palestine Liberation Organization (PLO) made back in 1993. Israel’s recognition of the state of Palestine is long overdue, especially after more than 130 countries—including the Vatican—have done so. 

This symmetrical recognition would also define the end game upfront as the outcome to which both sides are already formally committed—and then both sides can spend their negotiating energies on realizing two states living in peace.

“A regional agreement” – The notion that a regional track could substitute for the bilateral track suggests a failure to learn from the past. At many points throughout the history of this conflict, Israeli politicians and policymakers have sought to transfer the Palestinian issue onto other regional states—as in the Camp David I agreement with Egypt, or the suggestion that Palestinians should instead create their state in Jordan, a sovereign country. 

It is positive that Mr. Yadlin seems to embrace the Arab Peace Initiative (API) as a means for progress toward two states—but it can only play the role he envisions if it morphs into something it is not. 

The API is not a starting point for negotiations, but rather terms of reference for an agreement that Arab states would recognize as sufficient to gain Israel normalization within the Middle East. As such, Yadlin’s call for an “updated version” in which the “plan should be decoupled from the issue of the [occupied] Golan Heights” and “not be conditional on a solution to the refugee problem according to U.N. Security Council Resolution 194 from 1949,” do not take into account Arab governments’ own interests in these issues. Regional peace for Israel is unattainable without Israel first making peace with Palestinians.

“An interim bilateral agreement” – When Palestinians accepted the interim agreements of the Oslo bilateral process, there were 100,000 illegal settlers on the ground. Two decades of negotiations has left us with over 500,000 settlers and with the Palestinian community in the West Bank and Gaza further fragmented and battered. This is why the Palestinian leadership has been crystal clear in rejecting another interim agreement. 

Without more than verbal commitments to a viable two-state solution, and without a clear pathway to get there, another interim agreement would only allow Israel to create more “facts on the ground” that would preclude such a solution. It is hard to understand how such a proposal would offer Palestinians any hope of progress, given the experience of the past two decades. 

“In the case a negotiated agreement cannot be realized, an independent Israeli determination of its own borders” – It is even harder to understand how a unilateral Israeli determination of its own borders could, as Yadlin argues, “reinforce the agreed two-state solution paradigm,” especially because this would likely require massive Israeli military force (along with continued blind support from the United States) to create more facts on the ground. It’s understandable why Israelis would prefer to negotiate this conflict with themselves rather than engage with their adversaries, but it is the vast disparity in power between Israelis and Palestinians, not the logic of conflict resolution, that gives Israelis the realistic ability to do so. Still, this does not mean that unilateral decisions by Israel will one day find support among Palestinians. 

It’s understandable why Israelis would prefer to negotiate this conflict with themselves rather than engage with their adversaries, but it is the vast disparity in power between Israelis and Palestinians, not the logic of conflict resolution, that gives Israelis the realistic ability to do so.

It is the nature of international conflicts that they can “end” only in one of two ways: either the two parties agree to a solution that meets their mutual interests, or the side with greater power dictates, imposes, and enforces an outcome over the objections of the weaker side. In proposing unilateralism as a “solution,” Yadlin abandons the more sustainable former pathway for the latter, which I see as doomed. 

If Israel’s leadership is serious about reaching a two-state solution, the road is defined and clear. It requires that Israelis grapple with the real interests and demands of Palestinians as of equal substance and value to their own, rather than wishing them away. Equality can be achieved in two, truly independent states; or this conflict will default to a single state—as warned by President Obama and Secretary Kerry—marred by a civil rights struggle that may take another 70 years to bear fruition, but whose result is pre-defined.

Editors’ Note: To salvage his Middle East legacy, advance American interests in the Arab world, and align with the position of the international community on this conflict, Ibrahim Fraihat argues, President Obama must make the long overdue decision of recognizing a sovereign and independent Palestinian state before leaving office. This post originally appeared on Middle East Eye.

Driven by the search for his legacy in the Middle East, it seems President Barack Obama has decided to spend additional political capital on reviving Israeli-Palestinian talks before the end of his second term in office.

Last month, the Wall Street Journal reported that the White House is working on a renewed peace push, including a possible Security Council resolution or other initiatives such as “a presidential speech and a joint statement from the Middle East Quartet.”

While it is still unclear where President Obama is going with this renewed effort, he must understand that using the same old techniques of U.S. mediation will only exacerbate the crisis, consequently tarnishing his legacy in the Middle East. To salvage his Middle East legacy, advance American interests in the Arab world, and align with the position of the international community on this conflict, he must make the long overdue decision of recognizing a sovereign and independent Palestinian state before leaving office.

[U]sing the same old techniques of U.S. mediation will only exacerbate the crisis, consequently tarnishing [Obama's] legacy in the Middle East.

First, Obama should learn from the mistakes of his predecessors, George W. Bush and Bill Clinton, who also tried to reach a mutually acceptable agreement between the Palestinian and Israelis with only a few months left in office.

Reaching an agreement between the two parties under severe time pressure will not work. A party that is not interested in a peace agreement can easily maneuver by using delaying tactics until Obama’s term ends. Israeli Prime Minister Benjamin Netanyahu already utilized this strategy when he publicly rejected an invitation from Obama to visit the White House to talk peace because he wanted to “avoid any perceived influence” in the forthcoming U.S. presidential election. These remarks came from the same person who meddled in domestic American affairs by aggressively lobbying against Obama during the last U.S. presidential election.

Obama has already put in the effort by working with the parties, but now he needs to make decisions. Unlike many American presidents, Obama made the resolution of this conflict a top priority. Despite the brutal civil wars engulfing the Middle East region in the past five years, Obama demonstrated a firm commitment and allocated the needed political capital to make a breakthrough in the Israeli-Palestinian conflict. During his time in office, Secretary of State John Kerry spent more time on Israeli-Palestinian negotiations than any other international conflict. However, the outcome of the Obama administration’s intensive diplomatic efforts has been a total failure. These negotiations ended without an accord or even a memorandum of understanding, agreements that could have built on Obama’s legacy in the Middle East.

Nonetheless, Obama knows very well who made him fail. Netanyahu repeatedly defied Obama: In Congress, he refused to engage in serious negotiations that could have led to an agreement, and he publicly lobbied against Obama’s election for a second term. Obama should not expect Netanyahu to change his position and cooperate on any renewed efforts that could save Obama’s failed legacy in the Middle East. This is the same Netanyahu whom Obama increasingly grew frustrated with throughout his presidency.

With the remaining few months in office, the time has come for Obama to shape his legacy in the Middle East the way he wants it, not the way that Netanyahu has lobbied to characterize it. Obama has an opportunity to take his place in history as the first American president to officially recognize an independent Palestinian state.

Obama has an opportunity to take his place in history as the first American president to officially recognize an independent Palestinian state.

Sooner or later, there will be a Palestinian state and the United States will recognize it. Obama knows that very well. So why should he miss this opportunity and let another president recognize it in the future? Obama should worry about his own legacy, not Netanyahu’s extremist views. Obama should never allow Netanyahu to shape his legacy in the Middle East and leave it stained with failure.

Obama’s Middle East legacy is equally bleak in other parts of the region. Syria could become Obama’s Rwanda; Benghazi and the late Ambassador Chris Stevens are witnesses to his legacy in Libya; al-Qaeda in Yemen is much stronger today than when Obama intensified his drone policy against the organization; only history will tell how the Iran nuclear deal turns out in the future. Unfortunately, Obama cannot change the facts in any of these countries with the limited time remaining for him in office. However, he can still restore his legacy in the Middle East by recognizing a Palestinian state.

By recognizing a Palestinian state now, Obama will have seized an historical opportunity to impact the future and establish a foundation for the next American administration in the Middle East. No matter who comes to the White House, they will have to deal with this new fact. Obama has the international community on his side in recognizing Palestine. France recently stated that it will recognize an independent Palestinian state if a final effort to bring about peace fails. Additionally, Sweden has officially recognized Palestine.

American diplomats have a tradition of balancing their views after they leave office as they become free from the pressure of the Israel lobby and domestic politics. President Jimmy Carter is a one example of this.

Obama should not fall into this trap. No matter how he adjusts his views after leaving office, he will never save his legacy in the Middle East and the Israeli-Palestinian conflict if he does not recognize a Palestinian state while he still has the power to do so. The time is now and he must act rather than regretting it later.

President Obama, if not for your legacy, at least recognize Palestine for the Nobel Peace Prize that you received in advance. The committee trusted you and awarded you the prize before you achieved any real peace; do not disappoint them. Make sure you earn the prize, Mr. President. If not for your legacy or the prestigious prize, then please do something for your own personal pride and be the one who laughs last, not Benjamin Netanyahu.

Mr. President, recognize Palestine now.

Event Information

The Brookings Doha Center (BDC) hosted a panel discussion on April 19, 2016, about the ongoing reconstruction of the Gaza Strip. The panelists included Omar Shaban, director of Pal-Think, a research institution based in Gaza; and Naglaa Elhag, head of rehabilitation and international development at the Qatar Red Crescent Society (QRCS). Sultan Barakat, the BDC’s director of research, moderated the event, which was attended by members of Qatar’s diplomatic, academic, and media community.

Barakat opened by noting the slow progress of reconstruction in Gaza. Almost two years since the cessation of hostilities between Hamas and Israel, the rebuilding process has stalled for a number of reasons. First, the distribution of aid money pledged by donor countries during the October 2014 Cairo Conference has slowed. According to the World Bank, as of March 31, 2016, donor countries had dispersed only 40 percent of the pledged money. At the current rate, the fulfillment of all pledges will not occur until 2019, two years after the target date. Second, construction materials only enter Gaza from one border crossing. As a result of the sluggish rebuilding process, only 9 percent of totally damaged houses and 45 percent of partially damaged houses in Gaza have been repaired, leaving over 14,800 families internally displaced. Additionally, job opportunities promised by various construction projects have failed to materialize, leading to increased feelings of desperation and frustration among Gaza’s population.

Shaban expanded on these developments, expressing the notion that the people in Gaza feel neglected. Due to the high levels of frustration, he feels that a new round of hostilities between militants and Israel could happen at any moment. He explained further by highlighting the volatility of the area and mentioning how previous conflicts were easily ignited by an array of incidents: a kidnapping, a cross-border raid, an assassination, continuous rocket fire. Since frustration among Gazans continues to mount, arguably to its highest level, renewed conflict seems almost certain. Consequently, Shaban argued, fear of another round of conflict between Hamas and Israel has instilled a sentiment of donor fatigue. Donors do not want to see their support go to waste in another round of destruction, turning the delivery of assistance into an exercise of futility.

Shaban attributed this attitude among some donors to the lack of a political solution to the crisis in Gaza. Hamas, the de-facto governing authority in Gaza, does not work for the people, nor does the Palestinian Authority (PA), based in Ramallah. Neither body provides economic opportunities for Gazans, as those employed by either the PA or Hamas often do not receive their salaries. Reconciliation talks between both groups failed to establish a unity government. Egypt, Israel, and the United States would feel more comfortable negotiating with a unity government, presumably dominated by the PA, not Hamas, which each of the aforementioned countries designate as a terrorist organization. If the PA does reach an agreement with Hamas, Egypt has implied that it would open its border with Gaza at Rafah, as long as the PA stations a security presence at the crossing. This could enhance the slow trickle of construction materials into Gaza, allow for the increased export of commercial goods, and also enable Gazans to leave and return at a higher rate than currently permitted. According to Shaban, opening another access point for Gaza to the outside world would temporarily ease the burden faced by Gaza’s citizens, but the current crisis requires a solution to ameliorate the economic and political situation in the long term.

Elhag opened her remarks by reviewing the difficulties of implementing aid projects in Gaza. While working in Gaza for the QRCS, she noticed little progress from international agencies, as they do not address the main problems, typically taking short cuts, which she highlighted by stating, “We don’t treat the wounds, we cover it with a bandage.” To elaborate on this point she mentioned that lack of access in and out of Gaza and the Israeli naval blockade as two factors hindering reconstruction. Due to these restrictions, aid workers have difficulty entering Gaza. Elhag surmised that the lack of accountability on the part of international agencies and the Israelis and the fear of aid projects being destroyed again because of the political situation both contribute to the stalled reconstruction, producing grim realities in Gaza.

Furthermore, Elhag explained that a resolution to the Gaza crisis does not rest on the distribution of money. She believes that only solutions from both sides of the conflict will end the suffering in Gaza. To exemplify the frustrations felt by donors, Elhag noted that since 2008, QRCS invested $100 million in housing units and other aid projects in Gaza, but some of these projects were destroyed during the 2014 war. QRCS observed this and shifted their focus to securing food sources and enhancing the education and health sectors in Gaza.

At the conclusion of Elhag’s observations, Barakat asked the panel where the money donated for reconstruction goes and how the Gaza reconstruction mechanism (GRM) works. Shaban described how the money actually gets funneled through the PA’s ministry of finance in Ramallah, before it reaches Gaza. Hamas officials or members of Gaza’s civil society do not oversee any aspect of aid distribution. So from the start, the distribution of funds lacks transparency, as the PA gives the money to the U.N. office in Gaza, which administers the GRM. From there, the United Nations composes a list of people in Gaza that require construction materials. The Israeli administrative body in the ministry of defense, the Coordination of Government Activities in the Territories (Cogat), must approve the names on the list. Construction materials can then be distributed through the GRM. Shaban concluded his explanation of the GRM by noting the many levels of bureaucracy involved have created a slow distribution process for a populace in desperate need.

From the regional perspective, some Arab states’ past political differences with Hamas has stymied political progress in Gaza, but the panel agreed that some of these relationships, especially with Saudi Arabia, are on the mend. The work of regional actors like Egypt, Qatar, Saudi Arabia, and Turkey could help push a reconciliation deal between Fatah and Hamas. Shaban proposed allowing some Hamas members to take part in any future coalition government, as some of their relationships in Sinai could help Egypt secure the troubled region. Cooperation on security matters between Egypt and Hamas could inspire enough confidence in the Egyptians for them to open the Rafah crossing.

Ending the discussion, Barakat clarified the proposals of the panel by reiterating the need for donors to fulfill aid pledges. The GRM needs reform, especially through the inclusion of Gaza’s civil society in the reconstruction process. Finally, reconciliation between Fatah and Hamas, as well as Egypt and Hamas, would help foster security cooperation at the borders.

Video

• Reviving the stalled reconstruction of Gaza

Transcript

• Event Transcript (.pdf)

Event Materials

• gaza transcript

“We are not buildings artists; we are buildings leaders in society.” 

These stirring words of Juliano Mer Khamis, the charismatic founder of The Freedom Theatre (TFT) in Jenin refugee camp in Palestine, are coming true, despite his assassination five years ago. 

Against all odds, The Freedom Theatre, a beacon of creativity, discipline, and vision located in the heart of Jenin refugee camp, recently celebrated its tenth anniversary. Known for its fierce fighters and its conservatism, Jenin refugee camp, where over 16,000 live on one square kilometer, increasingly is known as well for its art. 

Juliano Mer Khamis returned to Jenin during the second Intifada to find his mother’s Stone Theatre (Arna’s Children tells her story) reduced - like so much of the camp—to rubble by Israeli tanks, and many of his mother’s student actors killed. In 2005 he joined forces with Jonatan Stanczak, currently Managing Director of TFT and Zakaria Zbeidi, a “Stone Theatre child” turned head of the Al-Aqsa brigades in Jenin, who later renounced militancy for cultural resistance. Together they rebuilt a theater in the camp, which evolved into The Freedom Theatre. 

Mer Khamis urged his acting students to wage a cultural intifada, warning that the occupation of the mind was more dangerous than the occupation of the body. Unlike many charismatic leaders, Mer Khamis developed an institution, not a cult of personality (even though he was adored). Following Juliano’s untimely and unsolved murder in 2011 — he was shot sitting in his car just outside the theater, with his infant son in his lap - the devastated theater soldiered on, a living testament to the powerful impact of his teaching and vision.

“When Juliano died he gave us the strength to continue and he showed us the strength we had in ourselves, so we kept going,”

Ahmad Matahen, age 24, a typical “child of The Freedom Theatre”, explained to me. Matahen joined in 2006; first as an actor, then as Juliano encouraged him to discover and exploit his individual talents, he moved into technology, engineering and stage design. He now studies stage design in Bethlehem, with the support of TFT, where he hopes eventually to work.

What a different future than Matahen might have had, if Mer Khamis had not invited in this street youth who had mocked the theater, and expressed his anger and frustration by throwing rocks at Israeli tanks. Matahen described the common attitude in Jenin:

“When you go to the camp and ask people what they want, they say they want to die. They have no jobs, no hope.”

When asked what he missed most after Juliano’s death, Matahen said “hugs”, something no one besides Juliano gave him. As a teenager, Ahmad, like so many of his contemporaries, saw his friends killed by the invading/occupying Israelis. Considered against the backdrop of trauma that pervades the camp, hugs are no small thing. They form the foundation for the self-confidence and sense of purpose that Matahen has gained from The Freedom Theatre.

High school dropout Ameer Abu Alrob defied his family and left his village to live and work at The Freedom Theatre. He traveled to India last year with a TFT group that also included two female acting students, for a ground-breaking, three-month Palestinian-Indian collaboration and tour with Janam Theater. Ameer and half of the other Palestinian student actors had never previously traveled outside Palestine, much less flown in a plane.

Through his experiences Ameer is not only broadening the horizons of his family and village, but, importantly, also introducing them to their own history through The Freedom Theatre productions such as The Siege. (One of the reasons Ameer dropped out was that school taught him nothing about his own environment and history).

Performed to date in Palestine and Great Britain, The Siege brings to life on stage the incident in 2002 during the second Intifada when armed Palestinian fighters along with some two hundred Palestinian civilians escaped the onslaught of Israeli gunfire and tanks by taking refuge in Bethlehem’s renowned Church of the Nativity. The trapped Palestinians - without food, water, or medical supplies - struggled to remain “steadfast”. After thirty-nine days, they surrendered, responding to the plea of a young mother whose baby’s life was at risk because the siege prevented her taking the infant to the hospital.

This decision, which reflected the fighters’ firm belief that the goal of their struggle was to help the Palestinian people, cost the insurgents dearly. In a European-brokered deal, they were exiled immediately upon exiting the Church — some to Europe and some to Gaza — with no hope of return (even though the European exile was supposed to last one year).

Nabil Al-Raee, The Freedom Theatre’s artistic director, explained that he wanted to re-open this important incident to present the Palestinian side, absent in the media. “This is the first time that we speak about these freedom fighters and tell their stories.” One and a half years of research, with travel to Europe and skype conversations with Gaza to interview those in exile, including personal friends of Al-Raee’s, were distilled into a visually stunning and dramatically taut production.

“The lesson of The Siege was putting weapons down,” 

according to one of the actors, Faisal Abu Alhayjaa, referring to the essential humanity of the Palestinian fighters, who would not harm a sick child for the sake of their cause.

This powerful message apparently was lost on New York’s acclaimed Public Theater which cancelled the production scheduled for this May. This alarming trend of performances cancelled/censored (take your pick) for political reasons will be examined at a conference at Georgetown University this June, where Al-Raee will speak.

Undeterred, The Freedom Theatre and its resolute supporters currently are seeking other American venues for The Siege. While some may see Palestinians on stage with machine guns, others, including sold-out audiences during The Siege‘s recent British tour, see, in the words of the Guardian review, “an unexpectedly compelling theatrical experience with a rough and ready energy, and in the very act of its telling, speaks for the voiceless and forgotten”.

In the tinderbox that is Israel-Palestine, The Freedom Theatre defies its seemingly hopeless environment, and is making a tangible difference in Jenin camp and beyond. Another child of the Theatre, an actor in The Siege and in the forthcoming feature film The Idol, Ahmed Al Rokh, described the change.

“We can feel the difference in the camp. Our audience is growing because the kids who first came now have families, and bring them. Now they understand that the theatre works for us and with us.”

In contrast to the situation in the developed world, where art is often considered discretionary, Faisal Abu Alhayjaa described art and culture in Palestine as “essential like water and bread”. Inspiring as it is, The Freedom Theatre’s story is not unique. The Palestinian Performing Arts Network (PPAN) includes many ensembles and organizations striving for dignity and agency through art.

Abu Alhayjaa sees the education and empowerment that comes through working in the arts generally, and The Freedom Theatre specifically, as vital to Palestine’s future.

“If there will be a liberation for Palestine, it will come with a generation that knows what they want, and that knows to think critically.”

That generation is being trained at The Freedom Theatre.

This piece was originally published by The Huffington Post.

Two years after Hamas and Israel agreed to a cessation of hostilities, reconstruction in Gaza has been painfully slow. This was the focus of a panel discussion at the Brookings Doha Center on April 19. As Senior Fellow and Director of Research Sultan Barakat explained, rebuilding has stalled in part because the distribution of aid money pledged by donor countries during the October 2014 Cairo Conference has slowed; according to the World Bank, donor countries had dispersed only 40 percent of the pledged money as of the end of March. At this rate, the pledged funds will not be dispersed until 2019, two years after the target date.

Moreover, construction materials only enter Gaza through one border crossing and must be cleared by layers of bureaucracy. As Omar Shaban—director of Pal-Think, a research institution in Gaza—explained, money for Gaza reconstruction is funneled through the PA’s ministry of finance in Ramallah, which transfers it to the U.N. office in Gaza. The United Nations composes a list of people in Gaza that require construction materials, and the Coordination of Government Activities in the Territories (Cogat)—an Israeli administrative body in the ministry of defense—must approve the names on the list. The U.N. then distributes construction materials. Shaban emphasized that the bureaucratic nature of this process has slowed reconstruction considerably, adding that the process isn’t transparent enough, since neither Hamas officials nor members of Gaza’s civil society oversee any aspect of aid distribution.

As a result of the sluggish rebuilding process, Barakat said, only 9 percent of totally damaged houses and 45 percent of partially damaged houses in Gaza have been repaired, leaving over 14,800 families internally displaced. Meanwhile, promised job opportunities in construction projects have failed to materialize, exacerbating feelings of desperation and frustration among Gaza’s population.

[T]he process isn’t transparent enough [said Shaban], since neither Hamas officials nor members of Gaza’s civil society oversee any aspect of aid distribution.

Shaban agreed that people in Gaza feel neglected. With high levels of frustration, he expressed fear that a new round of hostilities between militants and Israel could begin at any time. Previous conflicts were easily ignited—by a kidnapping, a cross-border raid, an assassination, or continuous rocket fire. Shaban argued that the volatility of the situation may be heightening fatigue among donors, who do not want to see their support go to waste in another round of destruction.

Naglaa Elhag, head of rehabilitation and international development at the Qatar Red Crescent Society (QRCS), discussed the difficulties of implementing aid projects in Gaza. She argued that international agencies do not always address the main problems and typically take shortcuts, saying of her own organization and others: “We don’t treat the wounds, we cover it with a bandage.” She highlighted various factors slowing reconstruction, including the lack of accountability on the part of international agencies, fears of renewed conflict, and the Palestinian political stalemate. Since 2008, according to Elhag, QRCS invested $100 million in housing units and other aid projects in Gaza, but some were destroyed during the 2014 war. As a result, QRCS shifted its focus away from physical reconstruction and towards food security, education, and health. 

A related problem is the Palestinian political stalemate. According to Shaban, neither Hamas (the de-facto governing authority in Gaza) nor the Palestinian Authority (PA, based in Ramallah) provides economic opportunities for Gazans, and those nominally on Palestinian government payrolls often do not receive their salaries. Reconciliation talks have failed to establish a unity government, making Egypt, Israel, and the United States reticent to negotiate. Egypt has indicated that if the PA does reach an agreement with Hamas, it would open its border with Gaza at Rafah (presuming the PA has a security presence there). This could increase the flow of construction materials into Gaza, allow for the increased export of commercial goods, and enable Gazans to come and go more frequently. But while opening another crossing for Gaza would temporarily ease the burden faced by the people there, Shaban stressed that a long-term political and economic solution is needed. Elhag, too, emphasized that a resolution to the Gaza crisis isn’t about the distribution of money—rather, she believes a joint Israeli-Palestinian solution is needed to end the suffering in Gaza. 

In the past, tensions between some Arab states and Hamas have also hampered progress in Gaza, but the panelists agreed that some of these relationships—especially with Saudi Arabia—are on the mend. Regional actors like Egypt, Qatar, Saudi Arabia, and Turkey could help push a reconciliation deal between Fatah and Hamas, which would help improve the situation in Gaza. And as Barakat stressed in conclusion, there is an urgent need for donors to fulfill aid pledges and for the Gaza reconstruction mechanism to become more inclusive, so that Gazans themselves can more fully participate in rebuilding their neighborhoods. 

Hamzah bin Laden issued a new video message this week, only his second ever, calling for all Muslims to support the Palestinian intifada. The 17-minute message coincided with a longer message from al-Qaida leader Ayman al-Zawahiri urging support for the Syrian branch of al-Qaida, the Nusra Front.

Hamzah's message says recovering Jerusalem and the al Aqsa mosque is the most important responsibility of every Muslim. He quotes his father Osama bin Laden, stressing that fighting Israel is the fundamental basis of al-Qaida's ideology and narrative. The video shows images of Palestinians clashing with Israeli soldiers. In the message, Hamzah says: "knives are our weapon; you should have no trouble finding your own knives."

Israeli border police run in front of Dome of the Rock during a protest after Friday prayers at a compound known to Muslims as al-Haram al-Sharif and to Jews as Temple Mount, in Jerusalem's Old City February 22, 2013. Photo credit: Reuters/ Muammar Awad.

Hamzah also urges all Muslims to kill Jews and "their interests worldwide." The United States should be attacked, he says, for providing Israel with $3 billion a year in assistance—which Hamzah predicts will rise to $5 billion a year soon. He says American-Israeli "security collaboration is at its highest level" and Americans "have to pay their bill with blood." Every Muslim "has to personally take part in defending the al Aqsa mosque by waging jihad to avenge our pure sisters who were killed in cold blood" by Israel.

Both Hamzah and Zawahiri laud the Syrian revolution for bringing al-Qaida to the border of Israel. The two messages were released by al-Qaida's media arm, al Sahab, a day apart. Their release ends a seven-month silence by both—they had not released any messages since last summer. Zawahiri has already released a second message lauding the late leader of the Afghan Taliban Mullah Omar and castigating the self-proclaimed caliph of the Islamic State Abu Bakr al Baghdadi.

Hamzah's message may be an indication that he is being groomed to be Zawahiri's successor. The 25 year-old favorite son of bin Laden is a charismatic face for the organization, which has been eclipsed in the global media by the Islamic State. By associating himself with Palestinian attacks in Jerusalem, Hamzah is trying to appeal to the widespread support in the jihadist movement for them.

In a lively and wide-ranging debate that aired earlier this month on Al Jazeera English, Brookings Executive Vice President Martin Indyk sparred with Head to Head presenter Mehdi Hasan about American efforts to resolve the Israeli-Palestinian conflict and the United States’ relationship with Israel.

Indyk began by stressing that American support for Israel is what gives the United States an influential role in the peace process and the leverage to encourage Israel to move towards peace. Indyk added that this does not mean that the United States should act as “Israel’s attorney” in the negotiations, and cited a promise he made to Palestinian leaders during the 2013-2014 peace talks led by Secretary of State John Kerry that Washington would not coordinate positions with Israel in advance. 

Brookings Executive Vice President Martin Indyk in a Head to Head interview with Al Jazeera English's Mehdi Hassan.

He pointed out that the United States has traditionally relied on its close relationship with Israel to encourage its leaders to take steps for peace and make offers to the Palestinians, and that no other potential mediator has been able to produce serious offers from Israel. “[The United States is] not neutral, we don't claim to be neutral. We have an alliance with Israel,” Indyk said. “But in order to achieve another interest that we have, which is peace in the region…and a settlement that provides for the legitimate national rights of the Palestinians, we need to be able to influence Israel.”

In responding to questions from Hasan and the audience, Indyk explained that he believes that both Israelis and Palestinians had made important concessions for peace, citing Israel’s acceptance of the Clinton Parameters in 2000, and the Palestinian Liberation Organization’s historic recognition of Israel as part of the Oslo Accords. Indyk also described the dramatic shifts in the way the United States has addressed the Palestinian issue over the past few decades, “from treating it only as a refugee issue and insisting that it be dealt with through Jordan to recognizing Palestinian national rights.” 

When asked about U.S. support for Israel at the United Nations, Indyk responded that this support is definitely warranted given the history of hostility towards Israel at the UN. However, he added that he personally wouldn’t oppose a carefully-worded resolution condemning Israeli settlements “so that the settlers in Israel understand that [settlement expansion] isn’t cost free.” Indyk rejected the notion that Israel has turned from a U.S. strategic asset in the Middle East into a burden, but explained that “making progress on the Palestinian issue enhances America’s credibility in the region and failing to make progress…hurts America’s credibility in the region.” 

Indyk concluded the discussion by reiterating his commitment to achieving Israeli-Palestinian peace and emphasizing that he would “never give up on trying to resolve this conflict in a way that meets Palestinian legitimate national aspirations to an independent and viable contiguous state living alongside Israel, a Jewish state, in peace.” 

Are Turkey and Israel on the verge of signing a normalization agreement, after a six-year hiatus? Comments in recent days by senior officials in both countries suggest so. A senior Israeli official, quoted in the Times of Israel, stated that “95% of the agreement is completed,” while Turkish Foreign Minister Mevlüt Çavuşoğlu said the parties are “one or two meetings away” from an agreement.

Media outlets in both countries have revealed that a meeting between senior Turkish and Israeli officials is expected to be held in Turkey on June 26—and that shortly after, an agreement is likely to be signed and go into effect. 

For two of America’s closest allies in the Middle East to bury the hatchet, reinstate ambassadors, and resume senior-level dialogue would surely be a boost for U.S strategic interests in the region. It would contribute to greater cohesion in dealing with the Syrian crisis, for example, and in the fight against the Islamic State. 

A quick recap

Let’s first recall how the crisis between the two former strategic allies developed, when in the aftermath of the Mavi Marmara incident (May 31, 2010)—resulting in the deaths of 9 Turks—Turkey recalled its ambassador in Tel Aviv and suspended nearly all defense and strategic ties with Israel. Israel also called back its ambassador in Ankara. At the time, Turkey set three conditions for resuming dialogue with Israel: a formal apology, compensation for the families of the victims, and a removal of Israel’s Gaza naval blockade. Relations came to a practical standstill, except in the economic sphere: trade between the two countries exceeded $5 billion in 2014, an unprecedented level. 

Israel formally apologized to Turkey in 2013 and in 2014 committed to paying compensation to the families of the victims. But the Gaza naval blockade has not been lifted. Turkey further demands greater access and presence in Gaza. For its part, Israel demands that Turkey not allow Hamas operative Salah al-Arouri, who resides in Istanbul, to coordinate terrorist operations against Israeli targets in the West Bank. Israel also wants Ankara to pressure Hamas to return the remains of two Israeli soldiers killed in the 2014 war in Gaza. 

Since the flotilla incident, Turkey was not always convinced that repairing relations with Israel actually served its interests. As the Arab Spring unfolded, Turkey hoped to assume a leadership role in the Arab and Muslim worlds—having good relations with Israel did not serve that purpose. And as Turkey went through periods of some unrest in the political arena (whether during the Gezi Park protests in 2013 or the hotly contested local and national elections), many in the ruling AKP party saw restoring relations with Israel as a potential liability in domestic politics. Israel, for its part, was mostly in a reactive mode: sometimes it tried to initiate contacts with Turkey, and sometimes it denounced Turkish anti-Israeli or anti-Semitic rhetoric.

The times they are a-changing

Now, however, new developments have prompted Turkey to seek a rapprochement with Israel. One key factor is the crisis in the Turkish-Russian relationship—in the aftermath of the suspension of the Turkish Stream natural gas pipeline project, Israeli natural gas is viewed as a possible substitute in the medium term for some of Turkey’s natural gas imports from Russia. And as the impact of the war in Syria on Turkey (including the refugee crisis and terrorist attacks) has made clear to Turkey that it must enhance its intelligence capabilities, and Israel can help. Israel, meanwhile, is searching for an export destination for its natural gas (Israeli Energy Minister Steinitz stated recently that “Turkey is a huge market for gas…they need our gas and we need this market”). Israeli leaders also know that resuming a political and military dialogue with Turkey may contribute to a more comprehensive view of the challenges Israel faces in the region. 

Five years after Israel’s formal request to open a representation office at NATO’s Brussels headquarters, Israeli Prime Minister Benjamin Netanyahu announced last month that NATO has approved the Israeli request. Turkey had opposed it, blocking progress, since NATO decisions are adopted by consensus. In a move seen signaling a thawing of relations, Turkey recently removed its objection to Israel’s request, paving the way to NATO’s decision. Israel continues to be a partner in NATO’s Mediterranean Dialogue along with Egypt, Algeria, Tunisia, Jordan, Mauritania and Morocco. 

At a time when Turkish President Recep Tayyip Erdoğan is attempting to strengthen his country’s regional strategic position and enhance its economic opportunities, a rapprochement with Israel makes sense. Bilateral negotiations are in the final stretch, as they have reached a compromise on the complex issue of Gaza and Hamas (Turkey will reportedly not demand the full lifting of Israel’s naval blockade on Gaza, settling for greater access and presence in Gaza. Israel will acquiesce to continued Hamas political activities in Turkey and will not demand the removal of Hamas operative al-Arouri from Turkey, but will get Turkish assurances that al-Arouri’s involvement in terror will cease.)

Fixing the troubled Turkish-Israeli relationship has been a mighty task for senior negotiators on both sides over the last few years, and although an agreement seems around the corner, the experience of recent years suggests that there can be last minute surprises. Israel’s Prime Minister had to jump over several hurdles, holding off pressure from Russia and Egypt not to seek rapprochement with Turkey, and ensuring support of the deal with Turkey from his newly appointed Defense Minister Avigdor Liberman, a known opponent of a deal. On the Turkish side, it seems that President Erdoğan wants a rapprochement with Israel, and feels that he needs it. This is tied directly to the Turkish domestic arena: Erdoğan has recently completed his consolidation of power, ousting Prime Minister Ahmet Davutoğlu and paving the way to the election of his trusted confidant, Binali Yıldırım, as prime minister. In addition, his new allies—the military-judicial establishment—are in favor of mending ties with Israel. One caveat is that Erdoğan’s top priority is establishing a presidential system, and so if he feels at any point that reaching an agreement with Israel will somehow undermine those efforts, he may opt for maintaining the status quo. 

Last month’s decision by the Palestinian Authority to schedule municipal elections in early October hardly registered in the West Bank and Gaza Strip, much less here in Washington. In light of Hamas’ recent decision to take part in the process, however, those elections have suddenly taken on new meaning. While the election of some 414 village, town, and city councils across the West Bank and Gaza Strip will not change the face of the Palestinian leadership or alter the diplomatic impasse with Israel, local elections have the potential to unlock the current paralysis within Palestinian politics.

Although Palestinian law calls for local elections to take place every four years, they have only been held twice since the creation of the Palestinian Authority (PA) in 1993, only one of which could be deemed genuinely competitive. The first and only local elections to take place in both the West Bank and Gaza Strip were held in 2004-05, in which Hamas—in its first foray into electoral politics—made major gains. Local elections were again held in 2012, although this time Hamas boycotted the process, preventing the vote from taking place in Gaza and allowing Fatah to declare a sweeping, if somewhat hollow, victory. 

Hamas’ decision to take part in this year’s local elections was therefore something of a surprise. Indeed, Hamas initially expressed dismay at the announcement, accusing the leadership in Ramallah of acting without consulting the other parties. Moreover, should the elections proceed as planned on October 8, they would be the first competitive electoral contest in the occupied territories since Hamas defeated Mahmoud Abbas’s ruling Fatah faction in the 2006 legislative election. Those elections triggered an international boycott of the PA which eventually led to the split between Fatah and Hamas and the current political paralysis.

If nothing else, Hamas’ entry into the elections averts another needless internal crisis in Palestinian politics. A boycott by Hamas would likely have further entrenched the political and geographic division between the Fatah-dominated West Bank and Hamas-ruled Gaza Strip, while dealing yet another blow to the beleaguered National Consensus Government, which despite being accepted by both factions in April 2014 has yet to physically return to Gaza. Movement on the reconciliation track could also help push the long-stalled reconstruction of Gaza, which has yet to recover from the devastating war of 2014.

Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other...[and Fatah] has little to gain from “winning” another electoral process that is largely uncontested.

What explains Hamas’ apparent change of heart? For one, Hamas may believe it has an advantage over Fatah, which continues to suffer from widespread perceptions of corruption and incompetence—a perception reinforced by the collapse of the peace process as well as the unprecedented unpopularity of President Abbas. Hamas may also view the upcoming vote as a way to gauge its current standing and future prospects in anticipation of long-awaited legislative and presidential elections. Either way, Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other. 

Hamas’ decision to participate in the elections is welcome news for Palestinian voters eager to see the return of competitive elections and a revival of political life after years of stagnation. It even helps Fatah, which has little to gain from “winning” another electoral process that is largely uncontested. More important, as the party that lost both parliamentary elections and a civil war in 2006-07 and that remains the chief proponent of a failed process, Fatah desperately needs a political victory of some kind as well as a basis on which to stake its claim to legitimacy and continued grip on power.

That said, it is important not to overstate the significance of local elections, which in the end will do nothing to address the deeper problems facing Palestinians in the occupied territories, whether from Israel’s continued occupation and its ever-expanding settlement enterprise or the ongoing political dysfunction within their own ranks. On the other hand, the prospect of the first competitive Palestinian elections in a decade represents a small but significant ripple in the otherwise stagnant waters of Palestinian politics.

Editors’ Note: One issue that has traditionally shared bipartisan support is how the United States should approach the Israeli-Palestinian conflict, write Sarah Yerkes and Ariella Platcha. However, this year both parties have shifted their positions farther from the center and from past Democratic and Republican platforms. How will that affect Obama’s strategy? This post originally appeared on the Israel Policy Forum’s blog, Matzav.

As the Republican and Democratic parties convene in Cleveland and Philadelphia, we expect to see numerous signs of the deepening polarization that has dominated this campaign season. One issue that has traditionally shared bipartisan support is how the United States should approach the Israeli-Palestinian conflict. However, this year both parties have shifted their positions farther from the center and from past Democratic and Republican platforms. This swing impacts whether the Obama administration, which has devoted significant time and resources to the negotiations, will issue a parting statement on the conflict.

In Cleveland last week the Republican party adopted a platform entirely dropping the two-state solution to the Israeli-Palestinian conflict, a move that puts the party further to the right than either AIPAC or Israeli Prime Minister Benjamin Netanyahu. The platform states, “We reject the false notion that Israel is an occupier and specifically recognize that the Boycott, Divestment, and Sanctions Movement (BDS) is anti-Semitic in nature and seeks to destroy Israel.” This language, combined with Republican nominee Donald Trump’s apparent disinterest in the conflict, makes it unlikely a Trump administration would prioritize Israeli-Palestinian issues or make any serious attempt at negotiations.

Conversely, this year’s Democratic Party platform reaffirmed the United States government’s long-standing commitment to seeking a two-state solution in the region. But the party took a notably progressive turn, highlighting both the importance of Israel’s Jewish and democratic future and Palestinian freedom “to govern themselves in their own viable state, in peace and dignity.” The contentious fight over the Democratic Party language, combined with Democratic nominee Hillary Clinton’s (and her potential First Gentleman’s) passion for this issue reveals an intent by a future Clinton administration to reinvigorate negotiations.

As President Obama and Secretary Kerry consider their final months in office, one item on the agenda is whether to push a last-ditch effort on the issue—either by releasing some sort of Obama or Kerry Parameters based on the outcome of the failed 2013-14 negotiations or by supporting one of the international initiatives such as the French Initiative, the Quartet Report, or the regional Arab Peace Initiative, now spearheaded by Egyptian President Abdel-Fattah el-Sissi.

Likely to drive the administration’s calculus are the Democratic and Republican nominees and their political motives on the U.S. led peace process. The time to watch for a potential move, therefore, is between November and January. Given the administration’s support for its own party’s nominee, it is in Obama’s interest to keep the peace process on life support—but without resuscitating it—through January. Publicly, but somewhat unenthusiastically, supporting the various international initiatives and allowing other states and international organizations to sit in the driver’s seat sets a future Democratic administration up with the best chance of success.

Lessons from getting Israeli and Palestinian leaders to the table over the years include the wisdom to refrain from yelling about past progress in negotiations. Publicly revealing how far Netanyahu and Abbas were willing to go in 2014 would only harm the next administration’s efforts at resuming negotiations. Keeping the “Kerry Framework” in the administration’s pocket allows a Clinton administration to take ownership of the peace process should she be elected.

Alternatively, if Trump is elected, the Obama administration would have nothing to lose in revealing the fruits of its efforts in 2013-14. The administration would have little concern for derailing a possible Trump attempt (which is not likely to take place in any event) and could determine that releasing some sort of Obama or Kerry Parameters would shed a positive light on the administration’s legacy. Furthermore, should the Republican Party win the White House, neither Obama nor Kerry is likely to care about the damage that releasing such a document might do to either Netanyahu or Abbas.

The party conventions have solidified the deep divides—both between and within the parties—regarding the U.S. approach to the Israeli-Palestinian conflict this campaign season. This divide, combined with a renewed international focus on the conflict, virtually guarantees that the administration will keep the conflict on the back burner before November. The election, therefore, will not only determine our next president but also the fate of the “Obama/Kerry Parameters”.

Note: Ariella Plachta, an intern with the Center for Middle East Policy, contributed to this post.

Event Information

As policy agendas for 2015 come into sharper focus, much of the national conversation is aimed at tackling challenges in biomedical innovation. The first two months of the year alone have seen landmark proposals from Congress and the Obama Administration, including the House’s 21^st Century Cures initiative, a bipartisan Senate working group focused on medical progress, President Obama’s Precision Medicine Initiative and a number of additional priorities being advanced by federal agencies and other stakeholders.

On March 13, the Engelberg Center for Health Care Reform hosted the State of Biomedical Innovation Conference to provide an overview of emerging policy efforts and priorities related to improving the biomedical innovation process. Senior leaders from government, academia, industry, and patient advocacy shared their thoughts on the challenges facing medical product development and promising approaches to overcome them. The discussion also examined the data and analyses that provide the basis for new policies and track their ultimate success.

 Join the conversation by following @BrookingsMed or #biomed

Video

• State of biomedical innovation conference: Panel 1
• State of biomedical innovation conference: Panel 2

Audio

• State of biomedical innovation conference

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20150313_biomed_transcript
• 313 MASTER DECK2

Editor's note: This article appears in the April 2015 issue of Global Forum. Click here to view the full publication.

Since passage of the Affordable Care Act in 2010, the last several years have seen a groundswell in physician payment and delivery reforms designed to achieve higher value health care through incentivizing higher quality care and lower overall costs. Accountable care models, for example, are achieving marked progress by realigning provider incentives toward greater risk-sharing and increased payments and shared savings with measured improvements in quality and cost containment. Medical homes are introducing greater care coordination and team-based care management, while the use of episode-based or bundled payments is removing perverse incentives that reward volume and intensity.

These reforms are coming just as the number of highly targeted, highly priced treatments continues to expand. The U.S. Food and Drug Administration (FDA) approved a decade-high 41 novel new drugs in 2014, many of them targeted therapies approved on the basis of increasingly sophisticated progress in genomics and the understanding of disease progression. In areas like oncology, such targeted treatments have grown as a percentage of global oncology market size from 11% in 2003 to 46% in 2013. New brand specialty drug spending in the U.S. is estimated to have been $7.5 billion in 2013, or 69% of total new drug spending. The growing prevalence of these drugs and their cost to the health system are setting the stage for significant flashpoints between industry, payers, and providers, seen most clearly in the debate over hepatitis C treatment costs that roiled stakeholder interactions for most of the past year. 

More of these targeted treatments are in the development pipeline, and a growing number of public policy efforts taking shape in 2015 are focused on accelerating their availability. The House of Representatives' 21st Century Cures Initiative, for example, has released a slew of legislative proposals aimed at promoting breakthrough innovation by increasing the efficiency of drug development and regulatory review. These efforts have significant downstream implications for the pace at which targeted and specialty therapies will become available, their associated costs, and the growing importance of demonstrating value in the postmarket setting.

As payers and providers continue their push toward increased value-based care, more innovative models for connecting such reforms to drug development are needed. Earlier collaboration with industry could enable more efficient identification of unmet need, opportunities to add value through drug development, and clearer input on the value proposition and evidentiary thresholds needed for coverage. Equally important will be unique public-private collaborations that invest in developing a better postmarket data infrastructure that can more effectively identify high value uses of new treatments and support achieving value through new payment reforms.

Stronger collaboration could also improve evidence development and the coverage determination process after a targeted  treatment has gained regulatory approval. Facilitated drug access programs like those proposed by the Medicare Administrative Contractor Palmetto GBA create access points for patients to receive targeted anti-cancer agents off-label while payers and industry gather important additional outcomes data in patient registries. More systematic and efficient use of policies like Medicare's Coverage with Evidence Development (CED), which allows for provisional coverage for promising technologies or treatments while evidence continues to be collected, could enable industry and payers to work together to learn about a medical product's performance in patient populations not typically represented in clinical studies. A CED-type model could be especially useful for certain specialty drugs: data collected as a condition of payment could help payers and providers develop evidence from actual practice to improve treatment algorithms, increase adherence, and improve outcomes. 

Finally, collaborations that support stronger postmarket data collection can also support novel drug payment models that further reward value. Bundled payments that include physician-administered drugs, for example, could encourage providers to increase quality while also incentivizing manufacturers to help promote evidence-based drug use and lower costs for uses that generate low value. Outcomes-based purchasing contracts that tie price paid to a medical product's performance could be another promising approach for high-expense treatment with clearly defined and feasibly measured outcomes.

Many of these ideas are not new, but as manufacturers, payers, providers, and patients move into an increasingly value-focused era of health care, it is clear that they must work together to find new ways to both promote development of promising new treatments while also making good on the promise of value-based health care reforms.

Quickly following on the heels of the midterm elections, Senate Majority Leader Mitch McConnell (R-KY) indicated that the medical device tax was a key target for repeal in the 114th Congress. Today, the Senate Finance Health Care Subcommittee will hold a hearing about the effects of the 2.3 percent tax that was included in the Affordable Care Act. Many believe that a repeal is, in fact, possible. Below is a basic primer about the tax and its contentious history.

Event Information

Established by the Food and Drug Administration Safety and Innovation Act of 2012, breakthrough therapy designation (BTD) is one of several programs developed by the U.S. Food and Drug Administration (FDA) to speed up the development and review of drugs and biologics that address unmet medical needs. In order to qualify for this designation, the treatment must address a serious or life-threatening illness. In addition, the manufacturer (i.e., sponsor) must provide early clinical evidence that the treatment is a substantial improvement over currently available therapies. The FDA is working to further clarify how it applies the qualifying criteria to breakthrough designation applications.

On April 24, under a cooperative agreement with FDA, the Center for Health Policy convened a public meeting to discuss the qualifying criteria for this special designation. Using examples from oncology, neurology, psychiatry, and hematology, the workshop highlighted considerations for the BTD application process, the evaluation process, and factors for acceptance or rejection. The discussion also focused on key strategies for ensuring that the qualifying criteria are understood across a broad range of stakeholder groups.

Video

• Breakthrough therapy designation: Two and a half years in
• Applying the breakthrough therapy criteria: Oncology
• Applying the breakthrough therapy criteria: Neurology
• Applying the breakthrough therapy criteria: Anti-infective/psychiatry/hematology
• Summary and discussion of lessons learned

Event Materials

• Breakthrough Therapy Designation_final
• Breakthrough therapy slide deck

Many proposals to accelerate and improve medical product innovation and regulation focus on reforming the product development and regulatory review processes that occur before drugs and devices get to market. While important, such proposals alone do not fully recognize the broader opportunities that exist to learn more about the safety and effectiveness of drugs and devices after approval. As drugs and devices begin to be used in larger and more diverse populations and in more personalized clinical combinations, evidence from real-world use during routine patient care is increasingly important for accelerating innovation and improving regulation.

First, further evidence development from medical product use in large populations can allow providers to better target and treat individuals, precisely matching the right drug or device to the right patients. As genomic sequencing and other diagnostic technologies continue to improve, postmarket evidence development is critical to assessing the full range of genomic subtypes, comorbidities, patient characteristics and preferences, and other factors that may significantly affect the safety and effectiveness of drugs and devices. This information is often not available or population sizes are inadequate to characterize such subgroup differences in premarket randomized controlled trials.

Second, improved processes for generating postmarket data on medical products are necessary for fully realizing the intended effect of premarket reforms that expedite regulatory approval. The absence of a reliable postmarket system to follow up on potential safety or effectiveness issues means that potential signals or concerns must instead be addressed through additional premarket studies or through one-off postmarket evaluations that are more costly, slower, and likely to be less definitive than would be possible through a better-established infrastructure. As a result, the absence of better systems for generating postmarket evidence creates a barrier to more extensive use of premarket reforms to promote innovation.

These issues can be addressed through initiatives that combine targeted premarket reforms with postmarket steps to enhance innovation and improve evidence on safety and effectiveness throughout the life cycle of a drug or device. The ability to routinely capture clinically relevant electronic health data within our health care ecosystem is improving, increasingly allowing electronic health records, payer claims data, patient-reported data, and other relevant data to be leveraged for further research and innovation in care. Recent legislative proposals released by the House of Representatives’ 21st Century Cures effort acknowledge and seek to build on this progress in order to improve medical product research, development, and use. The initial Cures discussion draft included provisions for better, more systematic reporting of and access to clinical trials data; for increased access to Medicare claims data for research; and for FDA to promulgate guidance on the sources, analysis, and potential use of so-called Real World Evidence. These are potentially useful proposals that could contribute valuable data and methods to advancing the development of better treatments.

What remains a gap in the Cures proposals, however, is a more systematic approach to improving the availability of postmarket evidence. Such a systematic approach is possible now. Biomedical researchers and health care plans and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the potential for large-scale, systematic postmarket data collection. Building on these efforts could provide unprecedented evidence on how medical products perform in the real-world and on the course of underlying diseases that they are designed to treat, while still protecting patient privacy and confidentiality.

These and other postmarket data systems now hold the potential to contribute to public-private collaboration for improved population-based evidence on medical products on a wider scale. Action in the Cures initiative to unlock this potential will enable the legislation to achieve its intended effect of promoting quicker, more efficient development of effective, personalized treatments and cures.

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• Download paper

Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur before a product gets to market. Many of these proposals – such as boosting federal funding for basic science, streamlining the clinical trials process, improving incentives for development in areas of unmet medical need, or creating expedited FDA review pathways for promising treatments – are worthy pursuits and justifiably part of ongoing efforts to strengthen biomedical innovation in the United States, such as the 21^st Century Cures initiative in the House and a parallel effort taking shape in the Senate.

What has largely been missing from these recent policy discussions, however, is an equal and concerted focus on the role that postmarket evidence can play in creating a more robust and efficient innovation process. Data on medical product safety, efficacy, and associated patient outcomes accrued through routine medical practice and through practical research involving a broad range of medical practices could not only bolster our understanding of how well novel treatments are achieving their intended effects, but reinforce many of the premarket reforms currently under consideration. Below and in a new paper, we highlight the importance of postmarket evidence development and present a number of immediately achievable proposals that could help lay the foundation for future cures.

Why is postmarket evidence development important?

There are a number of reasons why evidence developed after a medical product’s approval should be considered an integral part of legislative efforts to improve biomedical innovation. First and foremost, learning from clinical experiences with medical products in large patient populations can allow providers to better target and treat individuals, matching the right drug or device to the right patient based on real-world evidence. Such knowledge can in turn support changes in care that lead to better outcomes and thus higher value realized by any given medical product.

Similarly, data developed on outcomes, disease progression, and associated genetic and other characteristics that suggest differences in disease course or response to treatment can form the foundation of future breakthrough medical products. As we continue to move toward an era of increasingly-targeted treatments, this important of this type of real-world data cannot be discounted.

Finally, organized efforts to improve postmarket evidence development can further establish infrastructure and robust data sources for ensuring the safety and effectiveness of FDA-approved products, protecting patient lives. This is especially important as Congress, the Administration, and others continue to seek novel policies for further expediting the pre-market regulatory review process for high-priority treatments. Without a reliable postmarket evidence development infrastructure in place, attempts to further shorten the time it takes to move a product from clinical development to FDA approval may run up against the barrier of limited capabilities to gather the postmarket data needed to refine a product’s safety and effectiveness profile. While this is particularly important for medical devices – the “life cycle” of a medical device often involves many important revisions in the device itself and in how and by whom it is used after approval – it is also important for breakthrough drugs, which may increasingly be approved based on biomarkers that predict clinical response and in particular subpopulations of patients.

What can be done now?

The last decade has seen progress in the availability of postmarket data and the production of postmarket evidence. Biomedical researchers, product developers, health care plans, and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the powerful effects that rigorous, systematic postmarket data collection can have on our understanding of how medical products perform in the real-world and of the course of underlying diseases that they are designed to treat.

These and other postmarket data systems now hold the potential to contribute to data analysis and improved population-based evidence development on a wider scale. Federal support for strengthening the processes and tools through which data on important health outcomes can be leveraged to improve evidence on the safety, effectiveness, and value of care; for creating transparent and timely access to such data; and for building on current evidence development activities will help to make the use of postmarket data more robust, routine, and reliable.

Toward that end, we put forward a number of targeted proposals that current legislative efforts should consider as the 2015 policy agenda continues to take shape:

Evaluate the potential use of postmarket evidence in regulatory decision-making. The initial Cures discussion draft mandated FDA to establish a process by which pharmaceutical manufacturers could submit real-world evidence to support Agency regulatory decisions. While this is an important part of further establishing methods and mechanisms for harnessing data developed in the postmarket space, the proposed timelines (roughly 12 months to first Guidance for Industry) and wide scope of the program do not allow for a thoughtfully-, collaboratively-considered approach to utilizing real-world evidence. Future proposals should allow FDA to take a longer, multi-stakeholder approach to identify the current sources of real-world data, gaps in such collection activities, standards and methodologies for collection, and priority areas where more work is needed to understand how real-world data could be used.

Expand the Sentinel System’s data collection activities to include data on effectiveness. Established by Congress in 2007, Sentinel is a robust surveillance system geared toward monitoring the safety of drugs and biologics. In parallel to the program for evaluating the use of RWE outlined above, FDA could work with stakeholders to identify and pursue targeted extensions of the Sentinel system that begin to pilot collection of such data. Demonstration projects could enable faster and more effective RWE development to characterize treatment utilization patterns, further refine a product’s efficacy profile, or address pressing public health concerns – all by testing strategic linkages to data elements outside of Sentinel’s safety focus.

Establish an active postmarket safety surveillance system for medical devices. Congress has already acted once to establish device surveillance, mandating in 2012 that Sentinel be expanded to include safety data on medical devices. To date, however, there has been no additional support for such surveillance or even the capability of individually tracking medical devices in-use. With the recently finalized Unique Device Identifier rule going effect and the ability to perform such tracking on the horizon, the time is now to adopt recent proposals from FDA’s National Medical Device Postmarket Surveillance System Planning Board. With Congressional authorization for FDA to establish an implementation plan and adequate appropriations, the true foundation for such a system could finally be put into place.

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The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

Event Materials

• Bio sheet
• REMS CE Meeting Agenda
• REMS_CE_Meeting_Discussion_Guide_Final
• REMS CE Meeting Summary

For the last several years, the US government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions, which could have major impact on the pharmaceutical market.  When finalized it will be the largest free-trade agreement in history, impacting up to one-third of world trade and roughly 40 percent of the global gross domestic product. The deal has attracted a fair share of criticism from a wide range of groups, including concerns over proposed regulations for biologic drugs in participating countries. Specifically, critics are concerned about the length of data exclusivity granted to the companies that hold the patents on these drugs. Below is a primer on biologics and how they are being addressed in the TPP.

Biologic drugs include any therapy derived from a biological source; a group which includes vaccines, anti-toxins, proteins, and monoclonal antibodies. Because they are typically much larger and more structurally complex than traditional ‘small-molecule’ drugs, they are also more difficult—and much more costly—to develop and manufacture. Biologics are also among the most expensive drugs on the market, costing an average of 22 times more than nonbiologic drugs. Avastin, a cancer drug, can cost more than $50,000 a year, while the rheumatoid arthritis drug Remicade can cost up to $2,500 per injection.

Given these high costs, there is substantial interest in encouraging the development of biosimilars, a term used to describe follow-on versions of an original biologic. Estimates of the potential cost savings vary substantially, but some have predicted that competition from biosimilars could reduce US spending on biologics by $44 to $66 billion over the next ten years.  In the European Union, biosimilars have been on the market since 2006, and a 2013 analysis found that, for the 14 biosimilars on the market, the average price discount was about 25 percent. By 2020, the overall cost savings are projected to total $16-$43 billion.

After the Affordable Care Act (ACA) was passed in 2010, the US Food and Drug Administration (FDA) developed an accelerated approval pathway for biosimilars, modeled after the pathway used for the approval of small-molecule generics. In order to meet the criteria for biosimilarity, the drug must share the same mechanism of action for the approved condition of use, and there must be no clinically significant differences between the two drugs in terms of purity, safety, or potency. FDA recently approved its first biosimilar, Zarxio, which is a copy of the oncology drug Neupogen.

Under current FDA regulations, biologic drugs are granted 12 years of data exclusivity following approval. During this period of exclusivity, the FDA may not approve a biosimilar application that relies on the data submitted as part of the original biologic application. This form of temporary monopoly is distinct from patent protection, which is granted well before approval and is not related to clinical data.  Data exclusivity does not prevent another company from generating the data independently, but drug companies are unlikely to go to the considerable (and costly) effort of replicating a full course of clinical trials for a drug that is already on the market. (Though biosimilars may need to undergo some additional clinical testing under current FDA regulations, the amount of data required to support approval would certainly be less than what is required for an original biologic approval.)

The 12-year exclusivity period for biologics was established in the ACA following intense debate, and has continued to attract criticism. (By contrast, the period of data exclusivity is just five years for small-molecule drugs.) Supporters argue that given the greater cost and difficulty of bringing a biologic to market a longer period of exclusivity is necessary to incentivize innovation. Others argue that the resulting restrictions on competition keep drug prices unnecessarily high, inevitably putting a strain on the health system and keeping potentially life-saving drugs out of reach for many patients.

For the 11 countries besides the U.S. that are involved in the TPP, current data exclusivity protections range from zero (Brunei) to eight years (Japan). Under the Obama Administration’s current proposal, participating countries would increase those periods to match the US standard of 12 years. Curiously, this proposal directly contradicts the administration’s ongoing domestic efforts to lower the period of data exclusivity. Since the ACA passed, the Obama administration has repeatedly proposed reducing it to seven, arguing that this would save Medicare $4.4 billion over the next decade. Some have noted that, once the 12-year period is enshrined in the TPP, it will become significantly more difficult to change it through the US legislative process. Furthermore, imposing US standards on the 11 member countries would inevitably restrict competition at the global level, and many patient advocacy and international humanitarian organizations have argued that doing so would undermine the efforts of US global health initiatives like the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which rely on price competition to manage program costs.

It is unclear whether the US will be successful in its efforts. There have been reports that the issue of data exclusivity has become a significant point of contention, and the US delegation may seek to compromise on its demands. It may, for example, negotiate exceptions for the poorer countries involved in the negotiation, as the Washington Post notes. However, the details of the negotiations are largely confidential, which makes it challenging to assess the possibilities, their relative advantages, or how the US Trade Representative (which is leading the US negotiations) is balancing the need to ensure adequate incentives for innovation with the need to control drug costs and facilitate patient access to potentially life-saving therapies.

Editor's note: Elizabeth Richardson, a research associate in the Center for Health Policy, contributed to the research and writing of this post. 

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18 titled, “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

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Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for drugs or biologics that carry serious potential or known risks. Since that time, the REMS program has become an important tool in ensuring that riskier drugs are used safely, and it has allowed FDA to facilitate access to a host of drugs that may not otherwise have been approved. However, concerns have arisen regarding the effects of REMS programs on patient access to products, as well as the undue burden that the requirements place on the health care system. In response to these concerns, FDA has initiated reform efforts aimed at improving the standardization, assessment, and integration of REMS within the health care system. As part of this broader initiative, the agency is pursuing four priority projects, one of which focuses on improving provider-patient benefit-risk counseling for drugs that have a REMS attached.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held an expert workshop on July 24 titled, “Risk Evaluation and Mitigation Strategies (REMS): Building a Framework for Effective Patient Counseling on Medication Risks and Benefits”. This workshop was the first in a series of convening activities that will seek input from stakeholders across academia, industry, health systems, and patient advocacy groups, among others. Through these activities, Brookings and FDA will further develop and refine an evidence-based framework of best practices and principles that can be used to inform the development and effective use of REMS tools and processes.

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• REMS_PBRC_Meeting_Agenda
• REMS BR Speaker Bios
• REMS BenefitRisk Meeting Summary
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The role of clinical pharmacology and experimental medicine

The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development. 

On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.

Click here to access the full event agenda.

Video

• Introductory keynotes: Framing the issues
• Optimizing target and compound selection to enhance early stage decision-making
• The right dose for the right patient: Challenges and opportunities in dose optimization
• Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection
• Applications of clinical pharmacology to support demonstration of efficacy

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• Event Slide Deck
• Clinical Pharmacology Public Conference
• Clinical Pharmacology Backgrounder
• Clinical Pharmacology Private Roundtable

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The biomedical innovation ecosystem continues to evolve and enhance the processes by which treatments are developed and delivered to patients. Given this changing biomedical innovation landscape, it is imperative that all stakeholders work to ensure that development programs, regulatory practices, and the policies that enable them are aligned on and achieving a common set of goals. This will require a thorough reexamination of our understanding of biomedical innovation – and the subsequent ways in which we seek to incentivize it – in order to more effectively bridge research and analysis of the process itself with the science and policy underpinning it.

Traditional research into the efficiency and effectiveness of drug development programs has tended to focus on the ‘inputs’ and process trends in product development, quantifying the innovation as discrete units. At the opposite end of the research spectrum are potential measures that could be categorized as “value” or “outcomes” metrics. Identifying the appropriate measures across this spectrum – from inputs and technological progress through outcomes and value – and how such metrics can be in conversation with each other to improve the innovation process will be the focus of this expert workshop. On October 14, the Center for Health Policy at Brookings, under a cooperative agreement with the U.S. Food and Drug Administration, convened a roundtable discussion that engaged key stakeholders from throughout the innovation ecosystem to explore the factors and characteristics that could improve our understanding of what constitutes modern “innovation” and how best to track its progress.

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• FINAL 1014 BrookingsFDA Agenda
• FINAL 1014 BrookingsFDA Participant List

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Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.

Event Materials

• Continuous Manufacturing Agenda
• CM Panelist Bio Sheet
• Participant list
• Continuous manufacturing discussion guide
• allslides_Continuousmanufacturingworkshop_101915
• meetingsummary_101915_continuousmanufacturing

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The emerging field of precision medicine continues to offer hope for improving patient outcomes and accelerating the development of innovative and effective therapies that are tailored to the unique characteristics of each patient. To date, however, progress in the development of precision medicines has been limited due to a lack of reliable biomarkers for many diseases. Biomarkers include any defined characteristic—ranging from blood pressure to gene mutations—that can be used to measure normal biological processes, disease processes, or responses to an exposure or intervention. They can be extremely powerful tools for guiding decision-making in both drug development and clinical practice, but developing enough scientific evidence to support their use requires substantial time and resources, and there are many scientific, regulatory, and logistical challenges that impede progress in this area.

On October 27th, 2015, the Center for Health Policy at The Brookings Institution convened an expert workshop that included leaders from government, industry, academia, and patient advocacy groups to identify and discuss strategies for addressing these challenges. Discussion focused on several key areas: the development of a universal language for biomarker development, strategies for increasing clarity on the various pathways for biomarker development and regulatory acceptance, and approaches to improving collaboration and alignment among the various groups involved in biomarker development, including strategies for increasing data standardization and sharing. The workshop generated numerous policy recommendations for a more cohesive national plan of action to advance precision medicine.  

Event Materials

• 1027 Brookings biomarkers workshop agenda
• 1027 Biomarkers workshop backgrounderfinal
• 1027 Biomarkers workshop slide deckfinal
• 1027 Biomarkers workshop participant listfinal

It has been hailed as the most significant discovery in biology since polymerase chain reaction allowed for the mass replication of DNA samples. CRISPR-Cas9 is an inexpensive and easy-to-use gene-editing method that promises applications ranging from medicine to industrial agriculture to biofuels. Currently, applications to treat leukemia, HIV, and cancer are under experimental development.¹ However, new technical solutions tend to be fraught with old problems, and in this case, ethical and legal questions loom large over the future.

Disagreements on ethics

The uptake of this method has been so fast that many scientists have started to worry about inadequate regulation of research and its unanticipated consequences.² Consider, for instance, the disagreement on research on human germ cells (eggs, sperm, or embryos) where an edited gene is passed onto offspring. Since the emergence of bioengineering applications in the 1970s, the scientific community has eschewed experiments to alter human germline and some governments have even banned them.³ The regulation regimes are expectedly not uniform: for instance, China bans the implantation of genetically modified embryos in women but not the research with embryos.

Last year, a group of Chinese researchers conducted gene-editing experiments on non-viable human zygotes (fertilized eggs) using CRISPR.⁴ News that these experiments were underway prompted a group of leading U.S. geneticists to meet in March 2015 in Napa, California, to begin a serious consideration of ethical and legal dimensions of CRISPR and called for a moratorium on research editing genes in human germline.⁵ Disregarding that call, the Chinese researchers published their results later in the year largely reporting a failure to precisely edit targeted genes without accidentally editing non-targets. CRISPR is not yet sufficiently precise.

CRISPR reignited an old debate on human germline research that is one of the central motivations (but surely not the only one) for an international summit on gene editing hosted by the U.S. National Academies of Sciences, the Chinese Academy of Sciences, and the U.K.'s Royal Society in December 2015. About 500 scientists as well as experts in the legal and ethical aspects of bioengineering attended.⁶ Rather than consensus, the meeting highlighted the significant contrasts among participants about the ethics of inquiry, and more generally, about the governance of science. Illustrative of these contrasts are the views of prominent geneticists Francis Collins, Director of the National Institutes of Health, and George Church, professor of genetics at Harvard. Collins argues that the “balance of the debate leans overwhelmingly against human germline engineering.” In turn, Church, while a signatory of the moratorium called by the Napa group, has nevertheless suggested reasons why CRISPR is shifting the balance in favor of lifting the ban on human germline experiments.⁷

The desire to speed up discovery of cures for heritable diseases is laudable. But tinkering with human germline is truly a human concern and cannot be presumed to be the exclusive jurisdictions of scientists, clinicians, or patients. All members of society have a stake in the evolution of CRISPR and must be part of the conversation about what kind of research should be permitted, what should be discouraged, and what disallowed. To relegate lay citizens to react to CRISPR applications—i.e. to vote with their wallets once applications hit the market—is to reduce their citizenship to consumer rights, and public participation to purchasing power.⁸ Yet, neither the NAS summit nor the earlier Napa meeting sought to solicit the perspectives of citizens, groups, and associations other than those already tuned in the CRISPR debates.⁹

The scientific community has a bond to the larger society in which it operates that in its most basic form is the bond of the scientist to her national community, is the notion that the scientist is a citizen of society before she is a denizen of science. This bond entails liberties and responsibilities that transcend the ethos and telos of science and, consequently, subordinates science to the social compact. It is worth recalling this old lesson from the history of science as we continue the public debate on gene editing. Scientists are free to hold specific moral views and prescriptions about the proper conduct of research and the ethical limits of that conduct, but they are not free to exclude the rest of society from weighing in on the debate with their own values and moral imaginations about what should be permitted and what should be banned in research. The governance of CRISPR is a question of collective choice that must be answered by means of democratic deliberation and, when irreconcilable differences arise, by the due process of democratic institutions.

Patent disputes

More heated than the ethical debate is the legal battle for key CRISPR patents that has embroiled prominent scientists involved in perfecting this method. The U.S. Patent and Trademark Office initiated a formal contestation process, called interference, in March 2016 to adjudicate the dispute. The process is likely to take years and appeals are expected to extend further in time. Challenges are also expected to patents filed internationally, including those filed with the European Patent Office.

To put this dispute in perspective, it is instructive to consider the history of CRISPR authored by one of the celebrities in gene science, Eric Lander.¹⁰ This article ignited a controversy because it understated the role of one of the parties to the patent dispute (Jennifer Doudna and Emmanuelle Charpentier), while casting the other party as truly culminating the development of this technology (Feng Zhang, who is affiliated to Lander’s Broad Institute). Some gene scientists accused Lander of tendentious inaccuracies and of trying to spin a story in a manner that favors the legal argument (and economic interest) of Zhang.

Ironically, the contentious article could be read as an argument against any particular claim to the CRISPR patents as it implicitly questions the fairness of granting exclusive rights to an invention. Lander tells the genesis of CRISPR that extends through a period of two decades and over various countries, where the protagonists are the many researchers who contributed to the cumulative knowledge in the ongoing development of the method. The very title of Lander’s piece, “The Heroes of CRISPR” highlights that the technology has not one but a plurality of authors.

A patent is a legal instrument that recognizes certain rights of the patent holder (individual, group, or organization) and at the same time denies those rights to everyone else, including those other contributors to the invention. Patent rights are thus arbitrary under the candle of history. I am not suggesting that the bureaucratic rules to grant a patent or to determine its validity are arbitrary; they have logical rationales anchored in practice and precedent. I am suggesting that in principle any exclusive assignation of rights that does not include the entire community responsible for the invention is arbitrary and thus unfair. The history of CRISPR highlights this old lesson from the history of technology: an invention does not belong to its patent holder, except in a court of law.

Some scientists may be willing to accept with resignation the unfair distribution of recognition granted by patents (or prizes like the Nobel) and find consolation in the fact that their contribution to science has real effects on people’s lives as it materializes in things like new therapies and drugs. Yet patents are also instrumental in distributing those real effects quite unevenly. Patents create monopolies that, selling their innovation at high prices, benefit only those who can afford them. The regular refrain to this charge is that without the promise of high profits, there would be no investments in innovation and no advances in life-saving medicine. What’s more, the biotech industry reminds us that start-ups will secure capital injections only if they have exclusive rights to the technologies they are developing. Yet, Editas Medicine, a biotech start-up that seeks to exploit commercial applications of CRISPR (Zhang is a stakeholder), was able to raise $94 million in its February 2016 initial public offering. That some of Editas’ key patents are disputed and were entering interference at USPTO was patently not a deterrent for those investors.

Towards a CRISPR democratic debate

Neither the governance of gene-editing research nor the management of CRISPR patents should be the exclusive responsibility of scientists. Yet, they do enjoy an advantage in public deliberations on gene editing that is derived from their technical competence and from the authority ascribed to them by society. They can use this advantage to close the public debate and monopolize its terms, or they could turn it into stewardship of a truly democratic debate about CRISPR.

The latter choice can benefit from three steps. A first step would be openness: a public willingness to consider and internalize public values that are not easily reconciled with research values. A second step would be self-restraint: publicly affirming a self-imposed ban on research with human germline and discouraging research practices that are contrary to received norms of prudence. A third useful step would be a public service orientation in the use of patents: scientists should pressure their universities, who hold title to their inventions, to preserve some degree of influence over research commercialization so that the dissemination and access to innovations is consonant with the noble aspirations of science and the public service mission of the university. Openness, self-restraint, and an orientation to service from scientists will go a long way to make of CRISPR a true servant of society and an instrument of democracy.

Other reading: See media coverage compiled by the National Academies of Sciences.

¹Nature: an authoritative and accessible primer. A more technical description of applications in Hsu, P. D. et al. 2014. Cell, 157(6): 1262–1278.

³More about ethical concerns on gene editing here: http://www.geneticsandsociety.org/article.php?id=8711

⁴Liang, P. et al. 2015. Protein & Cell, 6, 363–372

⁵Science: A prudent path forward for genomic engineering and germline gene modification.

⁶Nature: NAS Gene Editing Summit.

⁷While Collins and Church participated in the summit, their views quoted here are from StatNews.com: A debate: Should we edit the human germline. See also Sciencenews.org: Editing human germline cells sparks ethics debate.

⁸Hurlbut, J. B. 2015. Limits of Responsibility, Hastings Center Report, 45(5): 11-14.

⁹This point is forcefully made by Sheila Jasanoff and colleagues: CRISPR Democracy, 2015 Issues in S&T, 22(1).

¹⁰Lander, E. 2016. The Heroes of CRISPR. Cell, 164(1-2): 18-28.

EXECUTIVE SUMMARY

In the face of unprecedented global challenges, effective global cooperation increasingly requires a partnership between state and non-state actors. Many international institutions now involve non-state actors in arenas that were once the exclusive province of states. The paper analyzes the evolution of civil society participation in the governance of international institutions and highlights the shift from a model based on consultation toward a model of multistakeholder governance. The paper argues that consultation is a less effective approach to involving civil society in achieving the mission of these institutions and suggests that more robust forms of multi-stakeholder participation by civil society can foster greater accountability and better deliberation. It analyzes competing claims about the desirability of including civil society in the governance of international institutions and suggests that an emerging constituency model can promote more effective multi-stakeholder governance. Constituency structures are already central features of several global health institutions and are now being contemplated by institutions in other sectors, including by the Education for All—Fast Track Initiative.

Multi-stakeholder approaches to governance are likely to become more widespread in the years to come in order to harness the contributions of a plethora of private actors engaged in responding to a wide range of global challenges. Even with enhanced cooperation between states, it is increasingly clear that non-state actors are essential to responding to key challenges across a wide range of sectors. Although it is possible to imagine expanded cooperation between state and non-state actors without opening up the governance structures of international institutions, it is less likely that these institutions will be successful in the longrun without a shift toward greater multi-stakeholder involvement in the institutions themselves.

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Despite the undeniable benefits of education to society, the educational needs, particularly in the world’s poorest countries, remain strikingly great. There are more than 67 million children not enrolled in primary school around the world, millions of children who are enrolled in school but not really learning, and too few young people are advancing to secondary school (van der Gaag and Adams 2010). Consider, for instance, the number of children unable to read a single word of connected text at the end of grade two: more than 90 percent in Mali, more than 50 percent in Uganda, and nearly 33 percent in Honduras (USAID n.d.).

With more young people of age 12 to 24 years today than ever before who are passing through the global education system and looking for opportunities for economic and civic participation, the education community is at a crossroads. Of the 1.5 billion young people in this age group, 1.3 billion live in developing countries (World Bank 2007). The global community set the goal of achieving universal primary education by 2015 and has failed to mobilize the resources necessary, as UNESCO estimates that $16.2 billion in external resources will be need to reach this goal.

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Results from this report were presented at an April 6 Center on Universal Education event at the Brookings Institution.

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