Public Health Policy In 2010: Research Funding And Regulations

Finding ways to fund research and regulating medication is critical to international public health policy and intellectual property rights specialists in 2010.

Neglected disease research is both necessary and expensive. Topping agendas of many public health advocates this year is finding ways to cut costs and create incentives for public and private sector research facilities to focus on finding cures even when there is no market to support them. A related issue is how to ensure that existing drugs get to where they are needed, and whether IP matters – such as counterfeit or customs enforcement policies – help or harm that goal.

Other leading policy issues include anti-competitive behaviour that might delay generic drug entry in the market, the length of data protection, ongoing concerns about pandemic influenza preparedness, counterfeit medicines, and technology transfer.

World Health Organization: Innovation, Flu, Counterfeit

At the World Health Organization, disagreements at the 18-23 January Executive Board meeting have pushed decision-making on key IP-related programming to the May World Health Assembly, which now has several additional pre-meetings added to the agenda (IPW, WHO, 20 January 2010 and 20 January 2010).

One key discussion will be on a report prepared under the auspices of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which is still in its implementation process.

An expert working group charged with finding innovative financing mechanisms for research on diseases disproportionately affecting developing countries presented its report to the Executive Board. But the group got off to a late start, and the full 85-page study was not made available until late Friday evening before the Monday start of the board meeting, and then only in English.

Frustrated that they were unable to have time to read anything other than the executive summary of the report (which was released a few weeks earlier), disturbed by early leaking of working group documents to pharmaceutical industry representatives, and in light of a letter from one of the working group members accusing the group of dismissing serious IP concerns in its research, delegates insisted that ongoing consultations were necessary before any decisions might be taken on basis of the report (IPW, WHO, 20 January 2010).

Web consultations are ongoing over the report, which has been made available in the six UN languages. These consultations will culminate in a 13 May consultation immediately prior to the WHO Programme, Budget and Administration Committee. The web consultation is taking place in the format of a public hearing, though only member states are invited to submit comments and inputs. These are due by 5 April 2010.

Director General of the WHO Margaret Chan has also launched an inquest at the WHO to search for the person responsible for leaking Expert Working Group documents to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which caused outcry from governments and civil society groups (IPW, WHO, 9 December 2009). The Expert Working Group was a key outcome of the Global Strategy and Plan of Action; it was established in November 2008 (IPW, WHO, 19 November 2008) and had its first of three meetings in January 2009.

Also scheduled prior to the World Health Assembly is a new intergovernmental meeting on preparing for pandemic influenza. After recent outbreaks of avian influenza in Southeast Asia, the WHO launched the first Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM), which met from 2007 – 2009. When, after two years, the IGM failed to finish an influenza preparedness framework – stalling in particular over IP issues and the controversial drafting of a standard material transfer agreement for the sharing of viruses and related benefits – WHO member states decided to let Chan finalise work (IPW, WHO, 18 May 2009).

The critical issue is that pandemic flu outbreaks seem to be originating in developing countries (Indonesia and then Mexico, so far) where there is often little capacity for the complex influenza vaccine manufacturing process. These countries want to ensure that they receive adequate benefits (in the form of vaccines and treatments), and are seeking ways to ensure that the commitment to provide those benefits is as binding as the commitment to share virus samples needed to create vaccines and treatments when an outbreak happens.

Chan was unable to come to an adequate solution (IPW, WHO, 22 October 2009), and at the January Executive Board, governments decided another intergovernmental process was needed in order to come to consensus on the outstanding elements of the framework. This meeting will take place from 10-12 May in the format of an open-ended working group. It is intended to be a one-time process: states are hoping the May meeting will solve remaining issues.

But a statement from Mexico at the Executive Board is perhaps a sign that all matters are not yet solved on influenza: when an outbreak of so-called swine flu (later declared a pandemic by the WHO) occurred within the country, they immediately shared samples of the virus but had not received adequate amounts of vaccine in return, the delegate said. Mexico prior to this statement had not been one of the developing countries most concerned about mandatory benefit-sharing in the framework.

Separately, influenza may come up at future meetings of the Strasbourg-based Council of Europe, which in January held a public hearing on the WHO’s treatment of the swine flu outbreak after certain members suggested it had been exaggerated as a way to increase sales of patented medicines.

At the May 2010 World Health Assembly, counterfeit medicine is again on the agenda after an 18 month delay.

At the 2009 Executive Board meeting, a report by the WHO-sponsored International Medical Products Anti-Counterfeiting Taskforce (IMPACT) sparked concern in several developing countries and civil society groups that intellectual property violations were being conflated with public health concerns. IMPACT is a partnership of international organisations, NGOs, enforcement agencies, pharmaceutical manufacturers associations, and drug and regulatory authorities.

This concern was fuelled further when evidence of delayed shipments of generic drugs being shipped through Europe came to light. While this issue has died down somewhat as there have not been new cases since early 2009, countries continue to bring it up at meetings of the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

If these initiatives continue, there is a danger that the “IP enforcement framework” will be used to address public health concerns, said Sangeeta Shashikant of the Third World Network. If that happens “the outcome will not be public health-oriented,” she added.

A revised report [pdf] was never discussed at the 2009 World Health Assembly, which was truncated due to the swine flu outbreak.

WHO research into counterfeit medicines did not stop, however, (IPW, 11 December 2009), and a new reportfrom WHO including national definitions of counterfeit medicines is expected to be out in time for the WHA.

WHO has also recently released new guidelines for treatment and procurement of medicines related to malaria.

Technology Transfer, Public-Private Partnerships

This year, there is an increasing amount of policy activity at the national and local levels.

Outside the multilateral system, public-private partnership and technology transfer initiatives are gaining increasing momentum.

On the intergovernmental side, 2010 is the year when a patent pool planned by drug purchasing mechanism UNITAID is meant to be established. According to its implementation plan [pdf], it should be an operational, independent entity by September. UNITAID’s board agreed at a meeting in February [pdf] that a memorandum of understanding governing the pool’s relationship with UNITAID will be finished by the end of June, including its first-year business plan, budget and performance indicators.

From the private-sector perspective, two major technology transfer initiatives have been launched in Brazil and India involving private companies, a GlaxoSmithKline patent pool continues to develop and the company has announced it will make 13,500 compounds related to the deadliest malaria strain available to any researchers interested in using them.

And the public-private financing institution the Global Fund to Fight AIDS, Tuberculosis and Malaria is reporting ground-breaking success and looking to replenish its coiffeurs for another three years of activity with two meetings scheduled on 24-25 March in the Hague and 4-5 October in New York (IPW, Public Health, 8 March 2010).

In Brazil, GSK and the Oswaldo Cruz Foundation, associated with Brazil’s Ministry of Health, announced in August of 2009 a partnership in research and development on vaccines for dengue fever and for the transfer of technology related paediatric treatment for pneumococcal disease; a vaccine against pneumococcal illness made in Brazil is being made available [in Portuguese] this year.

In India, the Wellcome Trust launched in 2009 five-year, £30 million (USD $46 million) technology transfer project intended to support research and development for affordable healthcare, and in partnership with pharmaceutical company Merck have created a new independent laboratory to work on affordable vaccines.

Pharmaceutical giant AstraZeneca announced on 11 March a licensing agreement with Indian generic manufacturer Torrent Pharmaceuticals in which Torrent will manufacture branded generics for sale by AstraZeneca in emerging markets. In a press release, the company said it plans to capitalise on the prediction that 70 percent of pharmaceutical industry growth over the next five years will be in emerging markets “and branded generics [generics launched by brand name companies, under a trade name rather than the non-proprietary drug name] represent approximately 50 percent by value in these emerging markets.”

Patent Linkages and Drug Regulation

Another closely watched issue this year will be an ongoing court case in India over whether the granting of regulatory approval for drugs will be linked to the product’s legal status regarding intellectual property rights.

Pharmaceutical company Bayer filed a complaint against Indian generic company CIPLA over an anti-cancer drug. Bayer owns a patent on the medicine that it says is valid until 2010, but CIPLA applied for regulatory approval of a generic version that, if marketed, would in Bayer’s eyes violate its IP (IPW, Public Health, 25 February 2009). Bayer said one government agency – the drug regulatory authority – should not be able to grant approval for marketing if another agency – the patent office – would prevent that marketing.

But civil society groups are concerned that this could cause problems for generic drugs entering into the market.

The Delhi High Court rejected Bayer’s arguments in August 2009 [pdf]. Bayer appealed, but the court pronounced on 9 February that it would not change its decision [pdf]. Now Indian patent blog Spicy IP has said Bayer intends to appeal to India’s Supreme Court. Bayer had asked the Supreme Court to hold the High Court’s decision – that is, prevent until the case is decided CIPLA moving forward – but the court denied the request, according to Indian news sources.

Meanwhile, streamlining of drug regulatory procedures is one of the key recommendations of the WHO’s expert working group report, and is one of the projects the WHO is working on as part of its global strategy implementation (IPW, WHO, 14 January 2010).

Work on this issue is being done through the WHO prequalification programme, a tool for (primarily UN) organisations that evaluates and then lists medicines that meet certain standards of quality, safety and efficacy.

This is critical because most neglected diseases are not found in developed countries, and many developing countries lack the technical knowledge to analyse the safety, efficacy and quality of new drugs, explained Pascale Boulet, IP and regulatory advisor at the Drugs for Neglected Diseases Initiative. “The WHO could fill this gap,” she said.

A WHO meeting on 26-27 July in Copenhagen [pdf] with drug manufacturers to focus on approvals for generic medicines.

Bilaterals Cause Alarm

The patent linkage debate is not the only hot-button case involving India, public health and IP this year. Bilateral negotiations since 2007 between India and the European Union have sparked worry among a number of public health non-governmental organisations, who say its provisions could limit access to medication throughout the developing world, which depends heavily on cheaper generics from India.

Europe’s parliamentarians have said they want the free trade agreement concluded by the end of 2010. They add that commitments under the FTA should not preclude access to essential medicines while India continues to develop from generic to innovator drug manufacture.

But Médecins San Frontières (Doctors Without Borders) has said that the FTA puts at risk the 92 percent of HIV/AIDS patients in developing countries who rely on India’s generic drugs industry for their care. And AIDS patients in New Delhi have come out in recent weeks to protest the agreement (IPW, IP Burble, 12 March 2010). These concerns have been sparked in part by higher-level protection of IP rights that may be required as a part of the bilateral deal.

Health Action International has a presentation [pdf] on the likely effects of EU FTAs on access to medicine in several countries, and an in-depth forecasting paper on the impact on Peru of the likely results of an EU FTA with the Andean region [pdf]. The Andean FTA sparked concern amount several civil society groups in 2009 [pdf].

Discussions on the IP section of Andean agreement closed 25 February, and include stringent IP protection measures (IPW, Public Health, 25 February 2010).

Eyes may well be on Thailand as well this year, as political changes might again bring pressure on the government for use of compulsory licences and other international flexibilities to IP rights to increase public access to medicines.

Antitrust, Data Exclusivity

In Europe, the consequences of an inquiry into the pharmaceutical sector will continue to be carried out this year. Already, the European Commission has launched a monitoring process of patent settlements between pharmaceutical companies to make sure that anticompetitive practices are not being carried out and has opened formal antitrust proceedings against one pharmaceutical company. In July of 2009, the EU found brand name pharmaceutical companies guilty of manipulating patent law to delay the entry of generic competitors into the market (IPW, European Policy, 8 July 2009).

And in the United States, ongoing debates in the healthcare reform bill may change the number of years companies can maintain exclusive control over test data needed to make generic versions of particularly complex medicines known as biologics (IPW, Year Ahead, 21 January 2010).