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Oct 11, 2016

US's Inconsistent Policies on Pharma Could Compromise Global Access to Medication

A recently released UN report highlights international "policy incoherence" on medication, but the US has denounced its findings, signalling its unwillingness to institute reforms.
Pills. Credit: The Javorac/ Flickr, CC BY 2.0

A recently released UN report highlights international “policy incoherence” on medication, but the US has denounced its findings, signalling its unwillingness to institute reforms.

Pills. Credit: The Javorac/ Flickr, CC BY 2.0

Pills. Credit: The Javorac/ Flickr, CC BY 2.0

Following public outcry against increases in drug prices, most notably by US presidential candidate Hillary Clinton, the high cost of medication has taken centre stage in the US. The country’s recent response to a UN report on access to medication brings to light its somewhat contradictory position on medication.

The report, released last month, was met with disappointment and rancour – mostly from the US and some sections of the pharmaceutical industry. While civil society groups have largely been welcoming of the report, some groups thought the panel could have been more ambitious in its recommendations. In particular they felt the panel could have laid stronger emphasis on bolstering countries’ commitments to rectifying the issue of compulsory licensing of drugs. Additionally, the panel could have further strengthened its language on human rights issues discussed in the report.

While the US has painted itself into a corner on its position on access to medicines, it is not the only country pushing for higher patent protection for its drugs. For instance, Switzerland has also pushed for stronger protection. But what specifically makes the US’s position so untenable is its own desire for cheaper drugs at home, particularly given the context of current domestic policy debates.

Issues with UN panel

UN Secretary General Ban Ki-Moon constituted the UN High Level Panel on Access to Medicines in November 2015 “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies”. The panel comprised former heads of state, academics, treatment activists, civil servants and representatives from the pharmaceutical industry, including both generic and branded drug companies.

The panel conducted two public hearings in the course of its consultations over the past year – in London and South Africa – and received over 180 different submissions from governments, industry representatives, civil society groups, academics and intergovernmental organisations.

Over the past few months, the US has made concerted efforts to display its opposition, including raising questions on the very premise of the panel.

Winnie Byanyima, executive director of Oxfam International and one of the members of the panel, said in an email, “The US government and the pharmaceutical industry have made their opposition to the high level panel and the resulting report clear from the outset. They are closely aligned in their fight to maintain a status quo that puts profits before people and has led to a dramatic rise in the cost of new medicines across the globe.”

In its submission to the panel earlier this year, the US government said that “the narrowly-focused mandate of the Panel was flawed” and that the panel could not address the inter-related issues that are barring access to safe, effective and affordable medicines.

Pressure from Big Pharma

In February this year, several pharma associations, including the Biotechnology Innovation Organization, National Association of Manufacturers, National Foreign Trade Council, Pharmaceutical Research and Manufacturers of America (PhRMA), the US Chamber of Commerce and the US Council for International Business (USCIB) wrote to Orrin Hatch, an American senator from Utah, alerting him to“the lack of transparency regarding the selection of the panel members and experts, the limited scope of inquiry…”

Hatch is the chairman of the senate finance committee and is widely seen as an ally of the pharma industry. So strong are the ties that in April this year, the senate finance committee also allegedly try to pressure Colombia in its efforts to grant a compulsory license on the Novartis cancer drug Glivec.

The associations urged Hatch to “work with the administration to support an effective interagency approach to safeguard innovation at multilateral institutions.” They cited “a positive precedent” set by the coordination between the US state department, office of the US trade representative and the US commerce department at the December 2015 UN Framework Convention on Climate Change (UNFCCC) negotiations held in Paris: “In Paris technical and IP (intellectual property) experts from different parts of the administration worked together to secure a final UNFCCC text that does not mention IP and thus removes uncertainty that could have discouraged continued investments by US companies in clean technology.”

On the other hand, civil society groups took active steps to seek answers from the US administration. In July this year, more than 50 civil society organisations wrote to the US secretary of state John Kerry asking him to explain whether the use of pressure on issues related to the access to medicines is consistent with the US’s policies and priorities. They expressed their concerns over the public statements made by state department representatives regarding the mandate, composition and work of the panel, including the US’s official submission to the UN panel.

Responding to queries sent over email, the state department said that it has responded to this letter and that the US intellectual property rights office met with some representatives from civil society on September 22 to discuss issues raised in their letter. “The incoming letter does not address the so-called ‘pressure exerted by the State Department on the High-Level Panel’ and this is simply incorrect,” a spokesperson from the state department said.

Contradictory policies

When the report was released last month, the US government denied the existence of any “policy incoherence” in its domestic policies and denounced the report as “fundamentally flawed” in a statement to the press. This policy incoherence between granting monopolies to drug companies and the people’s access to medication was one of the key issues that the UN panel was tasked to investigate.

Civil society organisations such as Knowledge Ecology International (KEI) rebutted the US government’s denial, pointing out the inconsistencies in US policy. James Love from KEI, who spoke to this reporter on the sidelines of the WTO Public Forum held in Geneva last week, said, “US government officials insist that no policy incoherence exists between R&D [research and development] incentives based upon high drug prices and access to the products.”

Love also pointed out inconsistencies in the US government’s stand on different medication-related issues being considered by the UN right now. He drew attention to the recently endorsed draft on antimicrobial resistance (AMR), which came about as a result of a high level meeting of the UN General Assembly and was released a week after the UN report on drug prices. “The US position on the high level panel was not consistent with the position on the same issue in the same fora in the same week, in the context of antibiotic drugs,” Love said.

Notably, section 10 (c) in the declaration on AMR states “…we acknowledge the importance of delinking the cost of investment in research and development on antimicrobial resistance from the price and volume of sales so as to facilitate equitable and affordable access to new medicines, diagnostic tools, vaccines….”

Critics also allege that the US’s domestic policies on access to medicines contradict its international stand on the issue.

Judit Rius, the US manager and legal policy advisor for Médecins Sans Frontières’s Access campaign said, “There is a disconnect between what the US says domestically and what it says internationally on the access to medicines.”

She drew attention to a recent article by US President Barrack Obama in the Journal of American Medical Association. In the article, Obama touched upon the challenges arising from the fact that the pharma industry opposes any changes to current US drug policy. “We need to continue to tackle special interest dollars in politics,” he wrote in reference to the domestic healthcare system.

Love said, “Drug prices are a huge issue within the US and the notion that high prices don’t interfere with access is absurd. We don’t want the US Department of State to block work on de-linkage. We need to move away from monopolies and high prices, while preserving or expanding incentives for new drug development. This is what de-linkage is about, finding a way to eliminate the conflict between R&D incentives and access”.

UN panel’s recommendations

Among the 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.

Ruth Dreifuss, co-chair of the panel and a former president of Switzerland, said in Geneva last week, “With this report, we wanted to find out if we can build on the big hope that was promised at the time of the Doha Declaration in 2001. Were countries able to use the flexibilities in the TRIPS agreement? Unfortunately the evolution did not happen as we had anticipated”. Dreifuss was referring to clause in the Doha Declaration that affirmed that the TRIPS agreement “can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all”.

In the past, the US and Switzerland have pushed for rights to file complaints against some countries over the loss of trade ‘benefits’ under TRIPS, although their IPR laws are consistent with international commitments.

Additionally, concerned about the the UN report’s take on human rights issues, the US made efforts to weaken the report’s language, according to some sources who did not wish to be named.

Speaking to this reporter later, Dreifuss denied the presence of any external pressures on the panel. “But there were good dynamics from within the panel,” she said.

Earlier in the year, the UN Human Rights Council passed a resolution on the access to medicines. At the time, Australia, the EU, Japan, Switzerland and the US had said that human rights cannot have primacy on international trade and investment regimes.

On this, Dreifuss said, “Even if all international treaties are equally binding, the implementation of fundamental human rights must take precedence over trade and investment agreements.”

The panel’s recommendations attempt to address all of these issues. Daniela Bagozzi, spokesperson for the Essential Medicines and Health Products Department at WHO said in an email, “The panel recommends negotiating a binding UN R&D convention that would delink the costs of R&D from the price of medicines. This is in line with the recommendations of WHO’s Consultative Expert Working Group on Research and Development: Financing and Coordination. However, this proposal has not gained much support among WHO member states over the past years. It thus remains to be seen whether this proposal will be endorsed by governments this time.” She said that the WHO is working on a fair pricing forum for 2017, to bring together all key actors and try to reach an agreement on pricing strategies to make medicines more affordable and expand access.

In India, although the UN report has been welcomed, concerns remain about how the country will respond to likely US pressure on the matter.

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