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Feb 02, 2018

Battle for Access to Medicines and Vaccines Takes Centre Stage at WHO

From prohibitive cancer drugs to making resources available to fight microbial drug resistance, or getting access to timely diagnostics - access issues are the cornerstone for equitable health systems worldwide.

From prohibitive cancer drugs to making resources available to fight microbial drug resistance, or getting access to timely diagnostics – access issues are the cornerstone for equitable health systems worldwide.

WHO Director General Dr Tedros Adhanom Ghebreyesus at the second day of the the 142nd Executive Board meeting. Credit: Credit C. Black/WHO

This is the second article in a two-part series on the 142nd Executive Board meeting at World Health Organization. You can read the first article here.

As the business of global health expands, inevitably the gatekeepers of international trade and investment have become important at World Health Organization (WHO) – the axis on which public health policy rests. Of the many policies that get formulated at WHO, discussions on the access to medicines including cost of drugs, transparency in research and development, transfer of technology have been contentious for years. In parallel, how the UN’s only norms-setting body engages with non-state actors while dealing with policies that have implications for giant businesses, has also drawn attention.

At this decisive stage in his tenure at WHO, Director General Dr Tedros Adhanom Ghebreyesus sits down to decide who gets a seat on the table and how he would preside over seemingly irreconcilable positions among member states on matters such as access to affordable drugs. Luckily for Tedros, his team and a constellation of invested member states will guide his decision-making on such crucial matters that are central to his aim of providing Universal Health Coverage to a billion people more among his other priorities.

At the conclusion of the 142nd Executive Board meeting last week, it is unclear the direction or the force with which the Tedros administration will align on such issues. But this period is crucial.

“Early in the tenure, leaders tend to get locked into positions that become very difficult to get out of. Inertia in policy-making sets in. So Tedros will have to be careful about the position he takes,” James Love of Knowledge Ecology International told The Wire.

From prohibitive cancer drugs that make it harder to fight the rising burden of non-communicable diseases; making resources available to fight microbial drug resistance; investments for neglected tropical diseases , or getting access to timely diagnostics – access issues are a cornerstone for equitable health systems worldwide even as overall health systems strengthening driven by countries is important.

While a significant part of the global disease burdens manifest in the developing world, the rewards for fighting these health conditions accrue to global pharmaceutical companies often located it developed markets. But what has changed over the years that have come to affect such facile calculations is the high cost of drugs that affect rich countries as well, eating into their health budgets and denying medicines to those in need. In addition, the benefits accruing to generic producers of cheap drugs in alliance with pharmaceutical giants have also changed the dynamics.

All these factors come to influence discussions at WHO during events such as the executive board meeting last week. While these issues have festered in Geneva for a long time, it is interesting to note the underlying change in politics that has come to govern the discussions on access to medicines.

This story will describe how discussions on two separate decisions related to access to medicines unfolded at the meeting and what they mean for the future.

In the first such contested debate on medicines under Team Tedros, the EB encapsulated how tense the fight is likely to be in the coming months and years.

As mentioned earlier, the meeting saw the United States and it allies on these issues (Switzerland, Japan, the United Kingdom) not unchallenged by emerging coalitions of member states. Brazil led the way, while India pushed for behind-the-scenes manoeuvres, not unlike others countries including Colombia. Among European Union countries, Malta, The Netherlands, Greece, Portugal and others played their part in guiding the discussions along their interests. (Official statements made by some of the member states can be read here).

The roadmap for access to medicines

At the meeting, member states discussed a report submitted to the Board on addressing the global shortage of, and access to, medicines and vaccines. After many deliberations before and during the board meeting, countries managed to get the Board to approve this decision that essentially asks Tedros to consult with countries and work on “a roadmap to improve access to medicines and vaccines, including activities, actions and deliverables for the period 2019−2023”.

The Executive Board has now recommended that this decision be adopted by the World Health Assembly in May this year. Further, such a roadmap will be considered in 2019 at WHO meetings.

Some countries have informally called this document and the decision as “the access to medicines agenda” with an overarching framework that will govern all these issues collectively at WHO.

“This effectively and firmly pins the access agenda in the WHO framework for the coming five years,” a delegate from one of the developed countries told The Wire.

As previously reported, getting some contentious issues formally placed at WHO meetings have not been straight forward, so a few countries are counting this as a strategic win.

The issue of shortage of, and access to medicines and vaccines, has repeatedly featured at key WHO meetings over the last few years. What was contentious this time was the explicit mention of the recommendations of the UN High Level Panel (UNHLP) on Access to Medicines which had divided countries and the mapping of these by WHO in the official document.

At the meeting Brazil, India and others commended WHO for referencing the UNHLP recommendations and appealed that these should be discussed and taken forward within the organisation. “It is politically symbolic that the UNHLP recommendations featured in a document that was finally approved by the Board,” one country delegate said.

Day 1 of the WHO Executive Board meeting. Credit: V. Martin

Day 1 of the WHO Executive Board meeting. Credit: V. Martin

Among the UN panel’s most significant recommendations is that “governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of the WTO Members to use TRIPS [the agreement on Trade Related Intellectual Property Rights] flexibilities”. The panel said that undue political or commercial pressure, including punitive measures against offending members, should be reported to the WTO secretariat and its members. (This, among other recommendations has been deemed problematic by the US).

In a statement at the meeting India said, “…Equitable access to medicines is denied due to market distortions and price barriers to procurement which may include IP provisions, extremely tight regulatory standards and monopolies.” In addition, the country also requested a detailed discussion on the recommendations of the UNSG’s HLP Report on access to medicines, particularly with respect to the use of TRIPS flexibilities.

India also drew attention to the 1st World Conference on Access to Medical products and International Laws for Trade and Health, held in November 2017 in New Delhi. A report on the conference was submitted to WHO. It makes specific recommendations for governments and other international organizations.

Public health, IP and innovation – the drama

The session that saw the most fireworks last week was when the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property (GSPoA) – a report that was commissioned by member states – was taken up.

The comprehensive review of the strategy charts the negotiations at WHO, the landmark report of the Consultative Expert Working Group on Research and Development (CEWG), discusses the developments in IP and innovation, documents the varied and diverse efforts to improve access to medicines including issuances of compulsory licenses for drugs, and other emerging challenges spread over the last decade until now.

The strategy failed on implementation and the review streamlines the previous work on the strategy and distilled 33 recommendations with a budget estimate of a little more than US $30 million to implement it effectively over the next five years. The review also listed 17 high-priority actions to meet hasten implementation of the strategy.

Among others, the recommendations pushed for national laws to reflect TRIPS flexibilities and improve transparency in R&D costs in addition to asking countries to commit spending at least 0.01% of their gross domestic product to basic and applied research relevant to the health needs of developing countries. The decision on this matter was the heart of the conflict on access to medicines at the EB.

The US and Switzerland, followed by Japan held a position that they were unable to support the decision. The US said that there was not enough consensus on the goals of the recommendations suggested by the overall review of the strategy. (Some of the recommendations were not a part of the original strategy and were not negotiated, it was pointed out.) This effectively blocked the decision from being approved even as member states pushed for consideration of the recommendations, fuelled by sustained efforts of more than 10 years on the matter.

Also read: Budget 2018: India’s Healthcare System Needs More Money and an Urgent Overhaul

The US made it clear that it was unhappy with WHO’s advocacy role on matters including on intellectual property – an area the US considered, as being outside the institution’s mandated expertise. It feared that potential long-term consequences to global innovation would be devastating. In addition, it effectively dictated what WHO can and cannot do. “The United States maintains it’s inappropriate for WHO to intervene on matters in the domain of the World Trade Organization, particularly with respect to interpreting member states’ legally binding TRIPS obligations.” (This also follows the stringent opposition of the US to the UNHLP panel and the strategy that pushes for WHO’s role in supporting the implementation of TRIPS flexibilities.)

The US, which is not a member of the Executive Board, called for a drafting group to revise the text of the decision related to the recommendations. Japan, a board member seconded the need for a drafting group.

Brazil led a blistering defence on the importance of not delaying the implementation of the recommendations. Brazil assured countries that the GSPoA is not against protection of intellectual property and that the recommendations do not threaten any industry. “We cannot reopen the TRIPS agreement here”, the representative from Brazil declared. The goal was to implement TRIPS and its flexibilities to meet public health needs.

Soon other countries including Iraq, Sri Lanka, Pakistan, Colombia, Thailand, The Netherlands among others coalesced around the position of Brazil. France, Germany, Sweden aligned with Canada to create a drafting group to revise the text of the decision.

Brazil maintained its position and tried to forge a way forward by stating that any revision will be limited to one or two changes in recommendations.

The consultations between countries outside of the EB proceedings continued over the course of the day without any agreement until the following morning.

Sources alleged that US, UK, Japan and Switzerland blocked elements of the recommendations on transparency on costs of research and development, delinking prices of drugs and costs of R&D and TRIPS flexibilities during the consultations of the working group.

Also read: Altered Dynamics at WHO, Priorities Likely to Be Constrained by Finances

It was only the next morning when the members reached an agreement on the text of the decision that turned out to be a watered down version of the originally proposed decision. The board now recommended this decision to be adopted by the assembly in May.

“You can imagine what happened inside the room,” one exhausted delegate told The Wire soon after the decision was approved by the board. Overall, countries were satisfied that they were able to save the bulk of the recommendations in the report. “It is better than nothing,” the delegate reasoned.

Essentially, the contentious recommendations that bothered the U.S. and others specifically on transparency around R&D costs were removed. In addition, the recommendation that asked countries “to identify essential medicines that are at risk of being in short supply and mechanisms to avoid shortages, and disseminate related information accordingly,” was done away with. So was the suggestion that countries commit spending on R&D.

The final text saw “national context” feature in the decision. This means that countries can adopt the recommendations in line with their national priorities. Sources said that most of the countries were not in favour of committing to spending a designated part of their GDP on basic and applied research relevant to the health needs of developing countries.

As a result, the revised decision makes the implementation of these recommendations less effective and more vulnerable to vagaries of national politics and interests. “In any case, WHO cannot tell countries what to do,” one developing country delegate said.

An HIV-positive nine-year-old in South Africa shows in 2014 the arsenal of antiretroviral pills he must take. Credit: Siphiwe Sibeko/Reuters

At the same time, nothing stops countries to implement these recommendations, with or without support from WHO, another country delegate told The Wire.

The task for the WHO secretariat is cut out. The recommendations have specific actions that WHO can implement including advocating for national laws to reflect TRIPS flexibilities and for use these laws to enable transfer of health technologies in countries.

“It appears the American industry was largely against many of the recommendations of the overall review of the GSPoA strategy. What was finally agreed lacks the venom of the original strong recommendations,” a source said.

“The US opposition to transparency on costs related to research and development is strategic. ‘We do not want to tell you how much it costs, because then we cannot charge high prices for drugs and make profits’, seems to be their position.’ It is unfortunate,” Love of KEI said.

One of the most important parts of the decision that was left out of the final decision was committing to spending upwards of US $30 million to implement the recommendations. (The annual budget of WHO is in the region of US $2 billion.) While WHO will need resources to implement the strategy, countries can also come together to find the budget necessary to implement it.

Citing an illustrative example on how countries can raise money, Ellen ‘t Hoen, an expert on medicines law and policy explained to The Wire, “If countries that pay the brand price for HepC medicines would switch to purchasing generics those savings would royally pay for WHO’s work. The list price of HepC treatment in the Netherlands is Euro 41,000. There are an estimated 28,000 HepC positive people in the country. In the scenario that everyone is treated, medicines would cost Euro 1,148,000,000. If the Netherlands would purchase generics with a compulsory license it can access the Euro 120 treatment offered by Pharco and the total medicines bill would be Euro 3,360,000. Even a small part of those savings would pay for WHO’s work on GSPoA and more.”

The DG has also been asked to come back with a report on the implementation of the recommendations in 2020. “For now, countries have kicked the can down the road and deferred immediate action,” a source said.

These efforts on the GSPoA are being seen as a subset of the overall access to medicines agenda discussed earlier. A few member states are keen on keeping the discussions on access to medicines active at WHO. “We will use several parallel tracks to keep the access issue on the agenda. The wider roadmap on the access to medicines, the specific recommendations of the GSPoA strategy and simultaneously push for new resolutions where countries will need to actually commit, such as the resolution on cancer prevention and control that was adopted last year,” a country delegate said.

On his part, it is hard to read how Tedros will push ahead on the issue of access. At the meeting he indicated a strong leadership of WHO on access to medicines. “We have transformed a department on access into a cluster (within WHO),” he said. In addition, member states and other stakeholder welcomed the appointment of Dr Mariângela Batista Galvão Simão, WHO’s new assistant director-general for drug access, vaccines, and pharmaceuticals.

He also seems to be of the view that there should be holistic discussions on access to medicines, instead of only focusing on delinking prices of drugs with costs of R&D.

Private sector engagement

In his many public statements on the matter of engagement with non-state actors, Tedros has been bold in his articulation on the importance of working with the private sector to deliver on the Sustainable Development Goals. “We should not be shy about working with the private sector,” he said during the EB meeting, adding that he had met with representatives from the private sector twice. (Later this month, WTO, WHO and WIPO host trilateral symposium on Sustainable Development Goals: Innovative technologies to promote healthy lives and well-being)

In a significant statement, India like others called for a follow up of the Framework of Engagement with Non-State Actors (FENSA) that was adopted two years ago by WHO. “A comprehensive conflict of interest policy covering both institutional and individual interests is yet to be developed.” India also cautioned that any collaboration in R&D should be in line with the FENSA framework.

The framework does not apply to countries and their engagement with non-state actors, it only applies to the WHO secretariat – something the new team must soon address.

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