Public Health In 2012: A Busy Crossroads Of Partnership, Innovation, And Trade

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From advancing public-private partnerships and increasing international collaboration to promoting innovation in neglected therapy areas and developing new research and development models, policymakers have set a steady pace as they advance the 2012 global health agenda.

At the same time, the impact of the economic crisis on public health programmes is already being felt. Slowed funding has raised concerns among stakeholders who are calling on countries to stand by their promises to keep up the support of proven policies. Other stakeholders worry that as negotiations on bilateral trade agreements near conclusion, key advances made in improving access to medicine are at risk.

Finding the Funds

The Global Fund announcement in November 2011 to cancel its next round of funding sent shock waves through the public health community. Due to insufficient resources, it had to halt funding new programmes until 2014. This year, the world’s largest backer of national programmes to fight HIV/AIDS, tuberculosis and malaria is hoping to come back to the community with some better news.

The Global Fund’s outgoing communications director told Intellectual Property Watch, “Despite the difficult financial environment, we are reasonably optimistic. We hope to be able to secure 12 billion US dollars in funding by the end of the year.” Their challenge is two-fold: try to get guarantees that current country pledges will be honoured as well as secure some new pledges to compensate for those that may not.

Beyond the difficult economic environment, the organisation is also dealing with its own internal issues (IPW, Public Health, 25 January 2012). According to the communications director, the Global Fund is working to “refocus the organisation and concentrate on sustaining gains as efficiently as possible with more restricted resources compared to the past.” Not an easy task the spokesperson admitted, likening it to “rebuilding a sailing ship.” Gabriel Jaramillo will be standing at the helm as general manager until February 2013, by which time a new executive director will have been chosen.

Feeling the Effects

Even though the Global Fund will continue funding programmes in place, some stakeholders say that the effects of the funding slowdown are already being felt. According to a Médecins Sans Frontières (Doctors Without Borders, or MSF) briefing on “How HIV/AIDS advances are being held back by funding shortages,” the slowdown is threatening the progress that has been made in the world’s fight against HIV/AIDS. MSF surveyed national HIV/AIDS programmes in nine sub-Saharan African countries, and reported that some countries were curbing treatment outreach due to funding limitations.

For example, the Democratic Republic of the Congo has adopted the WHO’s recommendations to initiate early antiretroviral therapy (ART) for the treatment of HIV in the country’s national guidelines. However, health authorities have not been able to implement them due to a lack of funding. In 2011, ART was capped there at 2,000 new patients even though 15,000 people were already on treatment waiting lists.

Sobering statistics considering that scientific data has confirmed that HIV treatment saves lives and helps to prevent the spread of the disease. In response to this disaccord between what science has proven necessary and what current funding allows, MSF has called on the Global Fund and donors to hold a new funding window in 2012.

An MSF access policy advisor told Intellectual Property Watch, “We are asking donors to step up and to hold an emergency donor conference to make a new round of funding available this year. Many countries have plans to implement WHO’s guidelines and they are ready to roll-out essential programmes like treating all seropositive pregnant women. But they can’t afford it to without new funds. Progress is being held back. An emergency donor conference just seems really necessary.”

The Medicines Patent Pool also expressed concerns over funding shortages. A Patent Pool spokesperson told Intellectual Property Watch, “What happens outside the Pool can be critically important to our work, and to the work of others in the field. A successful Pool can go a long way towards lowering the prices of HIV medicines around the world, but international funding for the purchase of those medicines is more than ever necessary.”

With its own funding secured for the next four years by UNITAID, the Medicines Patent Pool will continue the work of getting in licences from key pharmaceutical companies in 2012. After signing their first licence with a pharmaceutical company, Gilead Sciences, the Patent Pool will work to advance negotiations with other key companies including Boehringer Ingelheim, Bristol-Myers Squibb and F. Hoffmann-La Roche.

The organisation will also encourage remaining companies not in negotiations to get on board. Regarding Johnson & Johnson’s decision not to join, the Medicines Patent Pool remains optimistic. “We view the door as still open and have called on them to revisit the decision,” said the spokesperson.

The next International AIDS Society Meeting will take place in Washington, DC, on 22-27 July.

Innovating Innovation

The possibility of the creation of an international mechanism for research and development (R&D) has never looked so achievable as this year (IPW, WHO, 14 December 2011). The World Health Organization (WHO) consultative expert working group on research and development (CEWG) presented its progress report to the 130th Executive Board. Its final report will be presented during the 65th World Health Assembly (WHA), which will be held 21-26 May.

WHO Senior Advisor in the Department of Public Health, Innovation and Intellectual Property, Peter Beyer, said at a recent University of Geneva event, “I anticipate that this issue will dominate the debate in the upcoming WHA. And member states will have to decide whether or not they are willing to pay for R&D.” The WHA is the annual World Health Assembly, which will be held in May. The provisional agenda is available here [pdf].

The working group recognises the “need for strengthening global coordination of efforts to address R&D for developing countries and the importance of the WHO’s role in such coordination.” Its recommendations include precompetitive R&D platforms, open source, open access, prizes and a binding global instrument for health R&D covering both financing and coordination. Preliminary financing models include government commitments based on a defined contribution of GDP and financial transaction taxes.

Critics have already raised questions about the sustainability of the proposed R&D instrument. The CEWG is expected to present its final report to member states ahead of the WHA to advance the debate.

Advancing Public-Private Partnerships

Private sector contributions to the global health agenda have gained increasing importance and there are several key public-private collaborations to watch in 2012. “This year, we will continue to work with policymakers on the development of effective and sustainable solutions in the public health arena. We see this as the year where a lot of major policy items are coming to fruition,” Mario Ottiglio, associate director of public affairs at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), told Intellectual Property Watch.

The Pandemic Influenza Preparedness Framework (or the sharing of influenza viruses and access to vaccines and other benefits (PIP Framework) is one key example.

Andrew Jenner, director of innovation, intellectual property and trade at IFPMA, said the PIP Framework is a historic agreement. “It exemplifies the importance and potential of public private partnerships. But this is new territory. The challenge will be to ensure that the framework is effective in practice.”

“As partners, our vaccine companies remain keen to input with practical experience and technical expertise and we look forward to further collaboration with PIP partners through the WHO led process,” he said.

According to the PIP Advisory Group chair and vice chair, professors Didier Houssin and Tjandra Aditama, their work will be focused on two areas this year: “Establishing the partnership contribution and defining the uses of resources and starting negotiations of a new standard material transfer agreement, focusing on large multinational vaccine manufacturers in the first phase.”

The group’s next meeting will be held on 22-24 February during which time consultations with civil society organisations, and influenza vaccine, diagnostic and pharmaceutical manufacturers will take place (IPW, WHO, 7 February 2012). According to the chair and vice chair, “This initial contact will be followed by other interactions. The content, format and timing of these interactions must still be discussed by the group.”

Another key issue related to flu preparedness for the WHO this year is managing research on H5N1 avian influenza viruses. A panel of international experts met at the WHO from 16-17 February to discuss if research on the virus should be limited and to what extent. A need for policymaking on the issue became apparent when some scientists were stopped from publishing their research on strains of the virus with increased transmissibility due to fears that the data could fall into the wrong hands.

Also of great importance for the WHO agenda this year is its ongoing reform. Member states asked for more information and time for discussions on reform modalities during the Executive Board (EB) meeting in January. The EB set a meeting of the first intergovernmental working group meeting on programmes and priority setting on 27-28 February.

Spurring Research in Neglected Disease Areas

The World Intellectual Property Organization (WIPO) launched a major public-private partnership of its own last year. WIPO Re:Search brings together the public and private sector to share intellectual property and experience with the research community for the development of new drugs, vaccines, and diagnostics to treat neglected diseases, malaria, and tuberculosis.

Thomas Bombelles, consultant in WIPO’s global challenges division, told Intellectual Property Watch, “This year, our priority is concluding some concrete licensing agreements, expanding the database, and continuing signing on new partners.” McGill University in Montreal was the latest to join, bringing the combined list of supporters, providers, and potential users to 31.

The Drugs for Neglected Diseases Initiative (DNDi), a provider and supporter of WIPO Re:Search, continues to sign additional agreements with pharmaceutical companies, such as Sanofi and Abbott, for the development of new medicines for the treatment of neglected tropical diseases (NTD).

DNDi Executive Director Bernard Pécoul told Intellectual Property Watch, “These agreements are very important as they go beyond WIPO Re:Search in terms of accessibility and distribution of medicines that are developed through these initiatives.” Another key initiative for DNDi this year is a promise made in partnership with 13 pharmaceutical companies, the US, the UK, the Bill and Melinda Gates Foundation, the World Bank and officials from NTD-endemic countries to combat 10 NTDs by 2020 (IPW, Public Health, 30 January 2012).

Intersecting Health, IP, and Trade

International public health policymaking does not stop at the doors of the WHO, and collaboration between the world health authority, WIPO and the WTO continues to take on greater importance. The international organisations are working on a trilateral study entitled, “Promoting access and medical innovation: intersections between public health, intellectual property and trade,” which will be released this year. The report is meant to strengthen the capacity of policymakers by presenting the range of options available in promoting access and innovation and the impact and experience of various programmes.

WIPO has taken a closer look at its own public health-related activities. At the request of the Standing Committee on the Law of Patents (SCP), the secretariat prepared a document on WIPO activity related to patents and health, including interactions with international organisations. The document entitled, “WIPO Activities on Patents and Health,” http://www.wipo.int/edocs/mdocs/scp/en/scp_17/scp_17_4.pdf, was made available at the last SCP meeting.

At the next SCP meeting, which will be held from 21-25 May, the committee will continue discussions related to exceptions and limitations as well as patents and health. The deadline on the questionnaire on exceptions and limitations to patent rights was extended to 9 March and member states can expect a summary of responses at the upcoming meeting.

There are also two proposals on patents and health on the table. The proposal put forth by South Africa on behalf of the African Group and the Development Agenda Group (DAG) calls for a work programme to assist countries in adapting their national regimes to make full use of available flexibilities. The other proposal, submitted by the US on behalf of Group B countries, takes the focus off of flexibilities. A US official told Intellectual Property Watch, “Limitations and exceptions don’t go far enough in promoting access to medicines. Other approaches such as WIPO Re:Search, donation programmes, technology transfer – that’s what achieves results.”

The debate on the effectiveness of patent flexibilities in promoting access to medicine will also continue within the WTO Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This year, member states will continue assessing how the so-called “Paragraph 6 system” is working. The import-export mechanism intended to help countries lacking manufacturing capacity has only been used once when Rwanda imported a generic fixed dose antiretroviral drug from a Canadian company under compulsory licence.

Developing countries argue that the fact the waiver has only been used once demonstrates the system’s ineffectiveness and call for a workshop with broad participation to discuss the modalities of the system. Developed countries, on the other hand, insist the flexibility should be discussed within the Council first. A source familiar with TRIPS Council’s work said, “There are no signs that either side of the argument are changing their positions on the workshop proposal.”

The Paragraph 6 debate may be taken up at the next TRIPS Council meeting, which will be held 28-29 February.

Upcoming IP Cases and Events

For some stakeholders, the more pressing issue when it comes to developing countries’ use of patent flexibilities and promoting access to medicines are so-called TRIPS-plus bilateral trade agreements. A legal advisor at the Third World Network (TWN) told Intellectual Property Watch, “This trend of pushing TRIPS plus standards is one of the biggest challenges for us. It is clear that the US and the EU will continue pushing for stronger IP standards.”

One bilateral agreement that has been criticised by a number of NGOs, including the TWN but also Oxfam and MSF, is the EU-India free trade agreement under negotiation. They have raised concerns that the agreement includes overly stringent IP enforcement measures that would undercut India’s ability to produce medicines cheaply.

In a telephone interview with Intellectual Property Watch, an EU Trade Directorate press officer said, “There is nothing in the agreement that will hamper India’s capacity to act as the pharmacy to the world. This FTA will not change legislation on either side.” According to the officer, the overall agreement is expected to be concluded this year and nothing in the intellectual property chapter is expected to change by that time.

In response, an MSF access policy advisor told Intellectual Property Watch, “We have heard this before. There is no way that what they are proposing in this agreement would not have an impact on India’s ability to produce and distribute medicines. There are several different types of enforcement measures in the agreement aimed at tightening the space for generic companies to operate.” The policy advisor cited several examples, highlighting a provision that would create a “mandatory regime of provisional injunctions,” which could interrupt and negatively impact generic companies operations.

The policy advisor also indicated that MSF would be paying close attention to the upcoming hearing of the Novartis patent case in India. The advisor said that a ruling in favour of the Novartis could have a negative impact on future cases involving patenting of already known drugs in India.

Another area of concern for many access to medicines campaigners is a conference on IP enforcement being planned for April in Cape Town, South Africa. The US Department of Commerce Office of General Counsel Commercial Law Development Program is organising the event entitled “Africa Intellectual Property Forum: Intellectual Property, Regional Integration and Economic Growth in Africa.”

At least 100 NGOs signed and sent a letter to WIPO Director General Francis Gurry, calling for the summit to be cancelled due to conflicts of interest and a lack for concern for development and public interest (IPW, US Policy, 12 February 2012).

A TWN legal advisor said that the conference is part of growing strategy to link IP enforcement with quality and safety. A link, which the spokesperson rejects, “To say that IP enforcement is key to promote health is erroneous.”

The legal advisor also cited the distinction made by the WHO-led working group on substandard medical products by not including IP considerations in their recommendations. The working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products will present its report to the WHA in May (IPW, WHO, 28 February 2012).

Rachel Marusak Hermann may be reached at info@ip-watch.org.

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