Panellists: Price Is Main Barrier To Medicines Access In Rich And Poor Countries

A joint symposium of the World Health Organization, World Trade Organization and World Intellectual Property Organization this week included several panels on how trade, public health and intellectual property could positively interact to increase access to medicines.

This article looks at one of the panels. The trilateral event, Public Health, Intellectual Property, and TRIPS at 20: Innovation and Access to Medicines; Learning from the Past, Illuminating the Future, was held at the WTO on 28 October.

Although progress in access to some medicines has shown significant progress, such as HIV medicines, much more progress is needed, in particular for non-communicable diseases, according to panellists. High prices were underlined as being a major issue, now both for poor and wealthy countries.

Kees de Joncheere, director of the Essential Medicines and Health Products Department at the WHO, said important progress has been achieved in the access to medicines agenda, but this progress has been uneven. Prices for essential medicines continue to be an issue in low and middle-income countries, he said.

The greater success has been achieved in the area of HIV/AIDS, he said, with one of the reasons for it being the availability on the market of good quality generic drugs. Also part of the success is the “huge injection of international money for global procurement,” through organisations such as Gavi, UNICEF and UNITAID.

However, prices remain an issue for middle and upper-middle-income countries, he said. Those countries are not eligible for the lowest prices for medicines, or for global procurement.

The pharmaceutical industry’s projections show that the global pharmaceutical market will continue to grow in years to come, he said, with the growth taking place in emerging countries.

But the price of medicines is also of concern for rich countries, he said, with discussions and concerns on the affordability of health care sector and whether it can continue to be publicly funded, he added. Non-communicable diseases (NCDs) are a growing burden of disease for low and middle-income countries, not just about accessing the medicines, but also to ensure continuous treatment of people.

New diabetes and cancer drugs on the market are very highly priced and there is a need for looking at different models to make those drugs affordable, he said.

The WHO has issued a new model list of essential medicines this year, he said, with a number of important challenges, and important decisions to make in order to increase access for important public health problems. In particular, there has been a complete revision of the oncology medicines with 16 new oncology drugs, several of which are under patent and high priced.

TRIPS Flexibilities Widely Used

Ellen ‘t Hoen, medicines law and policy consultant and former head of the Medicines Patent Pool, talked about the actual use of the Doha Declaration on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health, as ongoing research she is undertaking at the University of Groningen and in the context of the Lancet Commission for Essential Medicines Policies.

Cases of use of the Doha Declaration are numerous, she said. Between 2001 and 2014, the use of TRIPS flexibilities was widespread. For example, 34 compulsory licences have been issued by 24 countries, she said. Some 48 instances of government use of patents occurred in 34 countries, and 23 least-developed countries used the TRIPS pharmaceutical waiver in 32 instances.

Asked later about the difference between a compulsory licence and a government use of patents, ‘t Hoen told Intellectual Property Watch that a compulsory licence is granted following a request by an applicant. For example, a generic company can ask for a CL once it asks for a voluntary licence and fails, she said. If the compulsory licence is granted a royalty rate is set.

“Government use is a form of compulsory licence exercised by the government directly where the government decides to make ‘public non-commercial use,’” she said. The government has to determine whether a royalty is payable but it does not have the obligation to first seek a voluntary licence, she said.

The United States and the United Kingdom used this widely in the 1950s and 1960s to procure medicines for government programmes, she said.

She mentioned a study by Andrew Hill, Department of Pharmacology and Therapeutics, Liverpool University, UK, and others.

The study showed the price at the time a product went to market in the US with possible target price based on cost of production. The price of imatinib, a cancer drug, in the US 10 years ago was $30,000, but it has tripled since then and today is US$106,000, she said. The lowest price available today in India is US$790, and if the demand increases a minimum target price can be US$159, she said at the panel.

The fact that a drug is placed on WHO essential medicines list should have consequences, she said, underlining the need to make new essential medicines affordable and available. Maybe it is time to think about an essential medicines patent pool, and establishing new rules for financing research and development for missing essential medicines, she said.

Compulsory Licences Not Best Money-Saver, Speaker Says

Meanwhile, Reed Beall, researcher at the Institute of Population Health, University of Ottawa, said the best procurement data is for HIV/AIDS medicines. However, there is no international medicine patent register and no standard practice to disclose international medicines patent holdings. Data for developing countries is also scarce, he said, so the patent landscape for medicines is very fuzzy.

Comparing compulsory licences with procurement in cooperation with global institutions such as UNICEF or the Clinton Foundation in terms of prices, he said he found that both strategies save money. He co-authored a study in March saying that compulsory licensing often did not produce lower prices for antiretrovirals compared to international procurement.

He remarked that the study was only focused on HIV/AIDS medicines, which benefitted from “an unprecedented global campaign,” and suggested that another campaign might be needed in other area.

The conclusion of the study shows that compulsory licences might not always be the cheapest, he said, “but sometime they are.” He remarked that the study was in no way against compulsory licences, which should be maintained as a flexibility.

At the time the study was published, ‘t Hoen and Jorge Bermudez, provided a letter to the editor of the study, later published by UNITAID. The letter stated: “The conclusion of Reed Beall and coauthors (Mar 2015) that ‘compulsory licenses are unlikely to be the best strategy for access to minimally priced drugs when international procurement is an available alternative’ is based on a lack of understanding of the international medicines market.”

 

Image Credits: Catherine Saez