Panellists Discuss Value Of Patent Pooling For HIV/AIDS, Potential For Other Diseases

A side event to this week’s World Intellectual Property Organization annual General Assembly highlighted the work of the Geneva-based Medicines Patent Pool in fighting HIV/AIDS, and discussed whether it makes sense for the patent pool model to be extended to other diseases.

 

UNITAID, which funds the Medicines Patent Pool, has issued a mandate to explore the feasibility of whether the patent pool could play a role in other disease areas, such as tuberculosis. The issue is in an early exploratory phase, sources noted.

The June meeting of the UNITAID Board included the following language in a resolution:

“[T]he Board also instructs the Secretariat to ask the MPP to prepare feasibility studies including risk assessments examining scenarios for the possible inclusion of TB and HCV as new disease areas to be addressed by the MPP.” HCV is hepatitis C virus.

Philippe Duneton, acting head of UNITAID, a World Health Organization-related agency that works to lower prices on medicines and diagnostics, said the Medicines Patent Pool “is an idea that works.”

At the 23 September event, Medicines Patent Pool Executive Director Greg Perry pitched the work and background of the patent pool. He said the model has been built for HIV/AIDS, and now the question is whether it could be used for other diseases, such as TB, hepatitis C, maybe others.

On HIV treatment, he said 35.3 million people live with it, 28.6 million need treatment now, and 12.9 million have access. Current gaps include affordable versions of newer medicines, combination pills, and special formulations for children with HIV.

Perry walked through four pillars of the organisation, which are to: share patents, reward innovation (such as with royalties), spur new innovation, and ensure access by accelerating the availability of more affordable versions of new ARVs to developing countries.

The pool works by helping to strike deals between patent holders and generic companies to market treatments in certain countries. Sometimes there is more than one patent holder on a full HIV treatment, he noted.

Perry described the “public health orientated” licences the pool seeks. They are: non-exclusive and pro-competitive; cover the widest number of developing countries; are non-restrictive; include technology transfer provisions; include flexibility to adapt to national needs; are consistent with TRIPS flexibilities; and are fully transparent.

New approaches ensure industry collaboration, he said, such as: tiered royalties, market segmentation (public-private), product segmentation (HIV/non-HIV use), hybrid agreements (price and licensing), out-licence management of sub-licensees and quality assurance, anti-diversion measures, and complementing existing access programs.

The Medicines Patent Pool has so far has licences signed on 9 priority HIV medicines, 10 ARV manufacturers (generics) have licensed, and there’s one hybrid agreement (price reduction). Another asset he mentioned was the pool’s patent status database.

WHO: ‘Time Has Come’ to Consider Other Patent Pools

In a presentation to the event, Zafar Mirza of the WHO Public Health, Innovation and Intellectual Property Division described the nature of the challenges on access to medicines in developing countries in HIV and other communicable diseases.

Mirza said he agreed with Duneton in suggesting that it seems the “time has come” to consider how other patent pools might be able to help address a number of unattended problems.

Mirza noted that WHO has six leadership priorities: universal health coverage; achieving the health-related Millennium Development Goals; address NCDs; implement the International Health Regulations; increase access to essential, quality-assured and affordable medical products; and reduce inequities by addressing social determinants of health.

Many of these priorities are not possible without access to medicines, he said.

Indicators of the problem of access include that between 20 percent and 60 percent of the health budget of lower-middle income countries (LMICs) goes toward medicines and technologies. And in those countries, up to 80-90 percent of medicines and medical products are purchased out-of-pocket rather than being paid by health insurance.

Also, the average availability of certain generic medicines in these countries is less than 42 percent in the public sector, and less than 72 percent in the private sector, he said.

Mirza presented a diagram of how medicines are related to different aspects of health systems. For instance, there are issues of governance, connected to market forces, innovation, transparency and donors’ agendas and funding. These are also connected to resources such as medicines, health information, health financing and human resources, overlying health infrastructure, and related to service delivery and better health outcomes.

A key statistic was that globally, around US$ 160 billion is invested in health research annually. Of that, only around $3 billion, less than 2 percent, is devoted to the neglected diseases of developing countries.

He cited a 2013 study in The Lancet that found that of the 850 new medical products registered from 2000-2011, only 37 were indicated for neglected diseases (those for which there is little profitable market because they mainly afflict poor populations).

Mirza talked about access issues with other types of disease.

He mentioned that the world risks facing a future of resistance to antibiotics, and that the pipeline for new antibiotics has been going down. He mentioned market failure in which there is a lack of innovation in areas lacking a potential market.

He discussed the case of hepatitis C, which some 160-180 million people in the world have, and the extraordinary price of treatment, such as $84,000 for a 12-week treatment course in the United States, compared to production costs of between $68-$136.

And with HIV and AIDS, he said those with access to antiretroviral (ARV) therapy in LMICs numbered 400,000 in 2003, and nearly 10 million in 2012, but that there are still 26 million of the eligible 34 million people living with HIV/AIDS in need of treatment.

A key lesson from the HIV response was that generic competition lowered prices for first-line ARVs from $10,000 per person/year to about $121 per person/year, he said.

Other lessons were: increased funding and the generic market through groups like the Global Fund for AIDS, Tuberculosis and Malaria; the possibility to manufacture in India; political will at the national and international level due to activist pressure; WHO standard treatment guidelines; UN/WHO prequalification programme for quality; voluntary licence agreements; Medicines Patent Pool creation; compulsory licences; patent oppositions in key producing countries; price reductions; and transparency.

Mirza also walked through the timeline of evolution of the issue at WHO, from 1996 to the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). He explained the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. Related to the discussion, he cited paragraph 4.3 on new mechanisms for transfer of and access to key health-related technologies, which includes the step to examine the feasibility of voluntary patent pools.

Discussion

Maximiliano Santa Cruz, head of the Chilean IP Office, said, “I think the experience gained by this team has to be used in other diseases.”

He said he is a supporter of the Medicines Patent Pool, which he described as good for innovation and for stakeholders. He said it is a complementary solution along with others, and that its transparency is very welcome.

Bernard Pécoul, director of the Drugs for Neglected Diseases initiative (DNDi), talked about different diseases such as TB facing increased multidrug resistance, and also discussed the case of hepatitis C. There, he said innovation has been “very productive,” with today 60 new drugs in the pipeline, but “unfortunately, access is not there.” They have “very effective treatment” that could serve the roughly 160 million affected population.

So the strategy is to attract different partners around the table, he said. With Ebola, there is nothing today, and a public health approach is needed.

Pedro Roffe, senior associate at the International Centre for Trade and Sustainable Development (ICTSD), said a “pro-competitive” system is needed, and that access to medicines has been a concern since the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

He said the Medicines Patent Pool has produced a number of good results in a few years.

Andrew Jenner, executive director of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), notionally accepted an expansion of the Medicines Patent Pool’s work, saying that if the principles underlying the Pool work, why not try it in other areas.

He signalled that industry has come to trust the Medicines Patent Pool. With that trust, industry may be willing to accept new conditions in its agreements. “There’s no reason to think” that the pool’s model couldn’t be applied elsewhere.

He said the tiered pricing model is “interesting,” mentioning China as a country where they would like to reach the poor but ask those who can to pay. These things will make it more attractive to partners, he said.

K M Gopakumar of the Third World Network, speaking from the audience, offered a critique to consider for future pools. For instance, he said the Patent Pool does not have equal bargaining found in other pools. He also said it appears the pool’s licences reinforce the status quo, by creating artificial segmentation with players locked into licences. He noted that in one agreement it was said it covered 110 countries, but that the appendix to the licence showed only 10 of those countries had patents, so drugs could be shipped freely there.

Perry answered that the Patent Pool’s licences cover some 94 percent of those in need. And on the licences, the licence relates to the exporting country’s patents, a source explained afterward.

 

Image Credits: Milena Marra