Drug Pricing, Generics Figure Into WHO Strategies On HIV, Hepatitis

As the 69^th World Health Assembly draws to a close, member states are in the process of approving a series of draft global health sector strategies for HIV, viral hepatitis, and sexually transmitted infections. And the issues involve some questions of intellectual property rights.
The 69th World Health Assembly is taking place from 23-28 May.

These strategies set targets for disease reduction and lay out recommended activities at the global, regional and country level. They are also intended to guide the development of national action plans.

The HIV and viral hepatitis strategies are notable for the provision they contain on the Medicine Patents Pool and their defence of the flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

This agenda item, 15.1, was approved today in committee (B), and will head to the closing plenary of the Assembly for final approval later today.

During the committee discussion of the agenda item this morning, a number of member states mentioned issues of TRIPS flexibilities and of high prices of medicines, such as hepatitis C in particular. It was pointed out, for instance, that due to generics, prices for a drug that cost about US$ 80,000 in some countries, was reduced to $900 per course for others.

Paragraph 102 of the Draft Global Health Strategy on HIV, 2016-2021 [pdf], A/69/31, reads, in part:

“The demand for affordable HIV treatment has resulted in comprehensive price reduction strategies for HIV medicines that may be applied to other medicines, diagnostics and health commodities. Strategies include fostering generic competition, including through, where appropriate, voluntary licenses that include pro-access terms and conditions such as those negotiated by the Medicines Patent Pool, and applying, as appropriate, the use of the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and in accordance with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, including compulsory licences and filing patent oppositions, differential pricing and direct price negotiations with manufacturers, as well as local manufacturing. WHO maintains databases on the prices of HIV medicines and diagnostics, and collaborates with the Medicines Patent Pool,1 which maintains a database on patent status to help countries achieve the best possible prices for these commodities.”

Similarly, paragraph 71 of the Draft Global Health Strategy on Viral Hepatitis, 2016-2021 [pdf], A/69/32, reads:

“The demand for affordable treatment for viral hepatitis B and C infection requires comprehensive price reduction strategies for medicines, diagnostics and health commodities, including for those medicines and diagnostics in the development pipeline. Strategies include fostering generic competition, including through voluntary licences, and using the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health. That would include compulsory licenses and filing patent oppositions, differential pricing and direct price negotiations with manufacturers, as well as local manufacturing n accordance with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property…

However, unlike the HIV draft strategy, the viral hepatitis strategy then continues…

“…[the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property] also notes that intellectual property rights are an important incentive for the development of new health care products. Different measures may have to be taken for different medicines and different countries, noting the differences in access barriers in low-income and lower middle-income countries as compared with upper middle- income countries.”

MPP Statement

The Medicines Patent Pool was among the NGOs making an intervention on this agenda item, in support of the draft strategies. It stated:

“The strategies offer a road map for addressing two major public health challenges and highlight the need to ensure supply of quality and affordable medicines. Voluntary licensing is identified as a way to enable competition among manufacturers and reduce prices. Negotiating voluntary licenses is the focus of MPP, the world’s first public health oriented licensing mechanism for medicines.”

MPP added:

“Following the recent mandate expansion into HCV, the MPP already negotiated its first license for daclatasvir – a new treatment in WHO’s essential medicines list. The license allows quality-assured manufacturers to make generic versions for supply in at least 112 countries. We welcome our close collaboration with the WHO in HIV and in viral hepatitis and look forward to working with Member States to further increase access to affordable treatments in developing countries.”

 

Image Credits: WHO