Ingredients For WHO Roadmap On Access To Medicines At Civil Society Side Event

On the side of this week’s World Health Assembly and hours before the Assembly agreed on preparing a roadmap on access to medicines, two civil society groups held an event on the same subject. The Brazilian ambassador, a senior official from the Netherlands, and a WHO assistant director general among others delivered their thoughts on the issue and the way forward. Key words were high prices, transparency, and trade flexibilities.

KEI’s James Love and HAI’s Tim Reed at the WHA yesterday

Knowledge Ecology International and Stichting Health Action International (HAI) held a panel discussion on WHO’s Roadmap on Access to Medicines and Vaccines on 23 May.

HAI published a policy brief on the way forward for access to medicines on 21 May.

Brazilian Ambassador Maria Nazareth Farani Azevêdo said access to medicines “invites my passion” on several fronts, in particular on the health, human rights, political, commercial and economic fronts.

Access is essential to universal health systems, she said, adding, “if you are a politician, you have to deliver on health. You won’t survive if you don’t deliver on health.”

Access to medicines is vital to every single aspect of the health agenda, she said, and the establishment of strong and resilient health systems depend on proper access to medicines, diagnostics, and vaccines. However, the topic of access to medicines remains the most pressing and the most controversial health scenario in multilateral fora.

She insisted on the importance of the balance between the legitimate right for industry to innovation and research and development (R&D) and the right to life of people.

“We have to join forces and open our hearts and mind,” she said, and find some common ground. The solution does not have to come against anybody’s interest, she added. The common ground can be found in the WHO roadmap on access to medicines, she said, underlining the role of civil society as a bridge builder between governments and the private sector.

EU Attentive to Issue, Preparing Report

Herbert Barnard, director of international affairs at the Dutch Ministry of Health Welfare and Sport, said the Netherlands is a strong supporter of access to medicines for patients. This was reflected in the 2016 Council of the European Union conclusion on strengthening the balance in the pharmaceutical systems in the EU and its member states, he said.

The conclusion identified the issue of access to affordable and innovative medical products within the EU, and potential actions to be taken, he said.

Such actions include closer cooperation between regulatory bodies, he explained, adding that the EU members were invited to prepare an evidence-based analysis of current EU instruments to facilitate innovation. According to the conclusion, the evidence-based analysis should also look at the availability, supply shortages, and deferred or missed market launches, and accessibility of medical products, “including high priced essential medicinal products for conditions that pose a high burden for patients and health systems.”

According to Barnard, the EU report is expected “anytime soon.”

On the WHO roadmap, he said it should be balanced at all stages of the value chain, the challenges should be addressed in an holistic manner, with attention to fair pricing, quality, and the appropriate use of intellectual property in stimulating innovation.

There is a need to seriously address the high prices of medicines, he said, and ensure affordability and availability of medicines now and for the future, adding that the issue goes beyond high prices. He said transparency on data such as R&D costs, clinical trial data, procurement prices and supply chain mark ups are important.

WHO: IP Discussion Not Closed

Mariângela Batista Galvão Simão, assistant director general, Drug Access, Vaccines and Pharmaceuticals at the WHO, remarked on the debate at the WHA on access to medicines (IPW, WHO, 24 May 2018) and said several member states framed access to medicines and vaccines in the human rights framework, including the EU.

At the end of the day, she said, public health professionals and activists need to make sure that policies for which they advocate are easy to implement. There are areas where no consensus is met, such as the delinkage between the cost of R&D and end prices, and the funding of R&D. The discussion on intellectual property is not closed, she said.

Procedures Should Not Be Patentable

James Love, director of Knowledge Ecology International (KEI), talked about the Chimeric Antigen Receptor (CAR) T-cell therapy which was approved in the United States for blood cancer. The basic technology, he said, is to drain the patient’s blood and isolate his/her T-cells to modify them with a publicly sequenced virus, then three weeks later reinject those T-cells. T-cells are white blood cells with key importance to the immune system.

The question is, is this therapy a product or is it a procedure, he asked. In KEI’s opinion, it is a procedure which is of prime importance as it is curing the patient and will soon be applicable to other cancerous tumours. A procedure should not be patentable, he said, and should be rejected by patent offices.

Love also commented on the concept of delinkage of R&D cost from end prices and said if the incentive for innovation is giving the inventor a monopoly, it should come as no surprise that prices are very high. Delinkage is the only way to have a permanent solution to high prices, he said, and the price of drugs cannot be an incentive for innovation. A feasibility study would prove the point but “we are not allowed to think about an alternative” model, he said.

TRIPS Flexibilities: ‘Jump and Swim’

Telling people that they should use the flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is like saying to someone “you are human so you can swim,” said Luis Villarroel Villalón, director of Innovarte in Chile.

It is important that the WHO helps countries to understand how to use the TRIPS flexibilities, he said. There is no guideline on how to run the process, which is complicated, he said. There is an urgent need for WHO to prepare standards for countries to look if they have the capability and human resources to run through this process, he said, explaining how Chile granted a compulsory licence for a hepatitis C medicines.

Cancer Drugs High Prices, Industry Flourishing

Ellen ‘t Hoen, director, Medicines Law and Policy, University Medical Centre, Groningen (Global Health Unit), also underlined the use of TRIPS flexibilities, and remarked on lessons learned with HIV, which could be useful to the debate on access to medicines.

Cancer drug prices are in the spot light, she said and there is an increasing resistance to high prices, in particular from oncologists. The “elephant in the room,” she said, is that the industry is doing very well, being one of the most profitable businesses on the planet.

She cited a Goldman Sachs report to industry which stated that curing patients is not a sustainable business model. The report cited the case of Gilead sofosbuvir against hepatitis C, which “made billions” out of the sale of the drug, but has “exhausted the pool of potential patients,” said ‘t Hoen.

Looking at figures, she said, “there is an immense pool of patients that are not treated.”

She suggested expanding the coverage of the Medicines Patent Pool to include all medicines on the WHO Essential Medicines List, and insisted on the need for greater transparency in the pharmaceutical industry.

Image Credits: William New