A recipient of the 2017 Prescrire Prize

This book, reviewed in the October edition of Prescrire International, and its accompanying website www.accesstomedicines.org discuss how stricter intellectual property rules have had a negative impact on access to medicines since 1995 all over the world (1,2). The author, formerly a member of the Prescrire team, has been spearheading international projects to promote access to medicines for over 30 years, notably for Médecins Sans Frontières/Doctors Without Borders (MSF) then Unitaid.

Patents not delivering on their public health objective
Drugs, as well as the industrial processes used to manufacture them, are patentable. A patent is an intellectual property right, granted by a country, which enables the patent holder to prevent others from making, using, importing or selling their innovation without their consent for a certain period of time. For drugs, the patent holder’s monopoly lasts for a minimum of 20 years. In exchange for the financial protection afforded to inventors, the public is meant to benefit from scientific advances.

In the pharmaceutical field, this system is not delivering on its public health objective. Most new drugs do not constitute an advance for patients. Drugs that would be useful but are not expected to be profitable are not developed (for example drugs for tropical diseases). Drug pricing is generally based on the maximum that health insurance systems can pay rather than on the true cost of the drug’s development.

As a result, low-income and high-income countries alike have to contend with exorbitant costs, which impede access to medicines and jeopardise public health insurance systems.

From a globalised patent system to the Doha Declaration
In 1995, the member states of the World Trade Organization (WTO) signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips), making it compulsory for WTO members to grant and enforce patents, including patents on drugs.

At the same time, the AIDS epidemic was spreading rapidly in developing countries, causing millions of deaths. The author describes the action taken by non-profit groups to promote access to generic antiretrovirals, against pharmaceutical companies’ strategies to defend their patent-based monopoly. This pressure resulted in 2001 in the WTO Doha Declaration, which established the primacy of public health concerns over intellectual property. In practice, the Doha Declaration clarified and strengthened the flexibilities provided in the 1995 Trips Agreement.

Flexibilities implemented to improve access to medicines
Two major mechanisms were put forward, mainly to improve access to antiretroviral drugs. The first enabled certain countries to grant "compulsory" licences, permitting the licence holder to produce or market a drug without the consent of the patent holder, under certain conditions. Compulsory licences have mainly been used as a means of applying pressure on pharmaceutical companies, often leading to the offer of a voluntary licence or a drastic price cut.

Secondly, "least-developed countries" obtained the right to postpone the requirement to comply with intellectual property rights for drugs until 2033.

Further progress was made in 2010, when the organisation Unitaid developed the "Medicines Patent Pool" for antiretroviral drugs. This international mechanism made it possible to negotiate voluntary licences at much lower prices than those obtained by individual countries.

As a result, in 2016, 87% of the HIV seropositive population of sub-Saharan Africa had access to antiretrovirals, mainly low-priced generic versions.

Reforming the system
The author observes that in all therapeutic areas and all countries, however wealthy they are, the goal of maintaining a system that delivers therapeutic advances at a reasonable cost appears incompatible with the current patent-based research and development (R&D) model. She explores a number of solutions, such as the "delinkage" model, which proposes funding R&D through means other than the drug’s sales price.

The book also addresses the protection afforded to clinical trial data, which delays competition from generics, and barriers to access to biological medicines, cancer treatments and hepatitis C treatments.

A major work
The book is a major reference work on access to medicines and the patent system. It is easy to read and includes a glossary, extensive supporting references and numerous examples. 

©Prescrire 5 October 2017

"Prix Prescrire 2017" Prescrire Int 2017; 26 (186): outside back cover. (pdf, free)

"Book review. Private patents and public health. Changing intellectual property rules for access to medicines" Prescrire Int 2017; 26 (186): 251. (Pdf, subscribers only).

Selected references from Prescrire's literature search
1- 't Hoen E "Private patents and public health. Changing intellectual property rules for access to medicines" AMB Publishers, Diemen (Netherlands) 2016: 181 pages, 45 euros excluding delivery. Downloadable free of charge from www.accesstomedicines.org.
2- Prescrire Editorial Staff "Pharmaceutical research and development: a new system is needed" Prescrire Int 2017; 26 (182): 130-135. > Pdf, subscribers only