Dealing with intellectual property issues linked to affordability and access to medicines, included in the WHO Essential Medicines List (EML).

Summary: 

New medicines added to the EML in May 2015 present a key opportunity to exercise the EML as a tool for access.

Since the access to HIV treatment crisis sparked a change in the paradigm for the EML, the WHO list increasingly includes patented and high-priced medicines, offering a possible window of opportunity to patients living with diseases, where treatment is often out of economic reach such as Hepatitis C, Tuberculosis and cancer.

With references to relevant WTO, UN and WHO documents this discussion paper offers a historical perspective on health and trade, international IP legislation and health and human rights, leading to the current situation in access to medicines.

Based on pricing and regulation analysis cases of medicines newly included to the EML, such as sofosbuvir, Bedaquiline and trastuzumab, the paper outlines that the EML is a practical tool, which can allow for options for achieving affordable access to patented Essential Medicines. The paper offers an easy-to-read overview of the selected options, incl. price negotiations, voluntary licensing and patent pools, TRIPS flexibilities and The CIPIH and GSPOA recommendations on intellectual property and public health.

Quotes:

– Several WHO experts stated in March 2015 that the Expert Committee on the Selection and Use of Essential Medicines, which recommends which medicines should be included on the EML, would have to face challenging questions on cost-effectiveness and affordability [2]. 

– If people around the world are to have access to essential medicines, the presence of these medicines on the EML is necessary, although it is not sufficient, to ensure that access. When WHO deems medicines to be medically essential, this should – as the Expert Committee asserted – be grounds for governments and other stakeholders to take action to ensure that the medicines are made available and affordable.

– The robust generic competition that brought down prices of early HIV medicines has become harder to achieve, both for newer HIV medicines and for medicines to treat other diseases that have a major impact on global public health – notably hepatitis C, cancer and tuberculosis, all of which can be better treated with the effective, and unfortunately expensive, new medicines just added to the EML. This new era of essential medicines does not benefit from the same political mobilization that led to action to address the HIV crisis.

– The new hepatitis C medicines are the first for which significant access problems are global; poor and rich countries alike are struggling to pay for these new medicines. The gap between monopoly prices and what is possible with a robust, competitive market is the difference between potential HCV treatment for all and treatment rationing due to limited health budgets. While licences secure generic production, a number of high-burden middle- and high-income countries cannot benefit from generic availability directly. This shows that other measures for accessing lower-priced DAAs, including the use of TRIPS flexibilities, remain essential until companies license under terms that can cover all in need.

– While the fulfilment of basic human rights is primarily a state obligation, in the case of patented medicines one also has to recognize the responsibility of the patent-holding pharmaceutical company. In the words of UN Special Rapporteur on the right to health, Paul Hunt: “Society has legitimate expectations of a company holding the patent on a life-saving medicine… Because of its critical social function, a patent on a life-saving medicine places important right-to-health responsibilities on the patent holder. These responsibilities are reinforced when the patented life-saving medicine benefited from research and development undertaken in publicly funded laboratories” [46].

– The label “Essential Medicine” should have consequences. It seems self-evident that when a proven effective medicine to treat a disease exists it should be made available and affordable to the patient and the community. When the market fails to do this, governments need to act. This will require dealing with patent and regulatory issues and may need international collaboration. A lack of action in this regard by governments and companies means depriving a population from access to important medical innovations and thus failing duties and responsibilities under human rights law.

– Countries can take measures at the national level but this risks country-by-country and medicine-by-medicine controversies related to intellectual property. Access to essential medicines should be predictable and requires a global approach and greater international collaboration.

Source:

Ellen ‘t Hoen and Kaitlin Mara.

Discussion paper: Ensuring that essential medicines are also affordable medicines: challenges and options. 2016 World Health Organization (Acting as the host organization for the Secretariat of UNITAID)

Link:

http://www.unitaid.org/images/marketdynamics/publications/Ensuring_that_essential_medicines_are_also_affordable_medicines_challenges_and_options.pdf

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