[Patralekha Chatterjee for IP Watch, Link (CC-BY-NC- SA)] NEW DELHI — Few topics in the global health agenda are as contentious as access to affordable medicines and medical care, and expectedly, divergent views permeated the discussions at a high-level conference in New Delhi, India last week. But if there is one thing that the three-day meet made amply clear, it was this: access to affordable healthcare has emerged as a global problem, and an emerging coalition of the like-minded, cutting across the developed and developing countries, is determined to have their voices heard in international policy circles on the issue.
The 1st World Conference on Access to Medical Products and International Laws for Trade and Health in the context of the 2030 Agenda for Sustainable Development was held in New Delhi from 21-23 November.
Organised by India’s Ministry of Health & Family Welfare with the support of the World Health Organization (WHO) Country Office for India in partnership with Indian Society of International Law, the conference brought together a wide range of stakeholders including many scientists and key government officials from India, the host country, academics from around the world, international NGOs like Médecins Sans Frontières and also patient support groups.
According to a concept note circulated in the run-up to the event, the aim of conference was “to provide a forum for stakeholder participation in access to medicines debate including trade and health policy” and “to inform policy in the framework of globalization and trade agreements for access to medical products for achieving SDGs” (the United Nations Sustainable Development Goals).
Key ideas emanating from the conference are expected to contribute towards discussions in the WHO Executive Board meeting in January.
Two examples tellingly brought out the concerns surrounding the issue of ‘access’ during the deliberations at the New Delhi meet.
First, that even a country as affluent as Switzerland did not offer unrestricted reimbursement of new hepatitis C drugs through health insurance to all patients till very recently. This led to many Swiss Hep C patients buying generic versions of the drug – manufactured under licence in countries like India – online or by travelling overseas, as Christoph Spennemann, legal officer, intellectual property unit, UNCTAD (UN Conference on Trade and Development), noted during one of his presentations.
Second, an intervention from the floor on the final day of the conference from Archana Panda, member of a group which calls itself Families of Spinal Muscular Atrophy India (FSMA India). Panda’s 15 year-old daughter suffers from Spinal Muscular Atrophy, and she recounted the travails of a distraught parent who has no choice but to mutely watch the condition of her child worsen though there is a new medicine for the ailment – Spinraza, a US Food and Drug Administration (FDA)-approved treatment from the multinational pharmaceutical company Biogen. The reason: the cost was prohibitive (USD 750,000 per year per child) and the manufacturer did not have any immediate plans for making the drug available in India.
Henk Bekedam, WHO representative to India, called it a “timely meeting” as “India, considered the pharmacy of the world, is now moving from generic drugs and vaccines to manufacturing medical products and diagnostics and access to medicines and medical products is key to universal health coverage.”
The New Delhi conference provided a huge platform to advocates of the UN High Level Panel on Medicines, and the report’s recommendations found mention in several sessions during the three days.
It also turned out to be an occasion where India sought to demonstrate that it is not without allies or support. India has been under serious pressure from countries that are home to multinational pharma companies, notably the United States, and remains on the Office of the US Trade Representative’s ‘priority watch’ list in its annual Special 301 report. This report unilaterally assesses the adequacy of trading partners’ protection of US intellectual property rights.
“The importance of IPR is acknowledged but that being said, we can’t say that price control especially for medicines doesn’t matter. If you want to sell in India, and it is an essential medicine, we have a right to control prices. Our population can’t afford high prices. Making profits is fine but making obnoxious profits is a ‘no.’ No country including the US allows it. Why should we be defensive? We have one of the best patent laws in the world,” Rajiv Aggarwal, joint secretary, Department of Industrial Policy and Promotion, India Ministry of Commerce and Industry, told Intellectual Property Watch. Asked about the attacks on India’s patent regime, Aggarwal laughed. “That is okay. Don’t worry about that.”
“There is still a difference of opinions between developed countries and developing countries. Developed countries are trying to kill TRIPS flexibilities, but we are getting new allies – WHO and UNCTAD are encouraging – there is increasing support for our policies,” G R Raghavender, joint secretary, National Mission for Justice Delivery and Legal Reforms, Ministry of Law and Justice India, told Intellectual Property Watch. TRIPS refers to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.
Ruth Dreifuss, co-chair of the UN High Level Panel on Medicines, former President of the Swiss Federation, and one of the prominent delegates at the conference, said in an interview, ‘What is important [about the conference] was that there were representatives from countries that can really push the WHO to take forward the proposals of the UN High Level Panel on Access to Medicines and persuade their own expert groups on access to medicines to take a step forward in practical terms. Countries like India, Brazil, South Africa can push for discussions that can lead to practical solutions.”
“Collaboration between countries in the South-East Asian region can be a key step if they are ready to have a common policy not just on registration of drugs but also on what is patentable and what is not. The other important aspect about the conference was its insistence on the fact it is not just about medicines but also vaccines, diagnostics and medical devices, Dreifuss added. “There is not enough awareness about the high prices of diagnostics.”
“It seems the government of India is taking research and development seriously within the country and is interested in linking with other countries at the global level. That is good,” Mohga Kamal Yanni, senior health and HIV policy advisor, Oxfam, Great Britain, and a member of the Expert Advisory Group advising the UN High Level Panel on Medicines, told Intellectual Property Watch.
“Even talking about transparency, low prices, R&D – all the issues raised by the UN High-Level Panel – and taking it forward, despite the huge pressure from countries like the United States and big pharmaceutical companies, is something!” she said. “India has started doing it; it needs to really invest in doing it and should really lead the discourse, with like-minded governments. Now, there are governments in Europe who say they have problems with pricing and look for other models of innovation and they all need to link with other developing countries like Brazil and South Africa and Egypt.”
During his inaugural speech, India’s Health Minister J P Nadda made it clear that India intended to align its public health goals with the government’s flagship programme ‘Make in India.’
“In India, nearly 150,000 orthopaedic knee procedures are done every day. More investments and more players in the medical devices sector will lead to lowering down of prices and access to medical products as most of the governments are sensitive to access and pricing of medical products,” Nadda said.
One issue which featured prominently in discussions about intellectual property rights, trade, and access to medical products was the use of TRIPS flexibilities, the shorthand for public interest safeguards in the TRIPS agreement.
UN Sustainable Development Goal (SDG) 3, which speaks of the need to ‘ensure healthy lives and promote well-being for all at all ages’, has specific references to the 2001 Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the TRIPS agreement regarding flexibilities to protect public health, and, in particular, provide access to medicines for all, Anand Grover, senior advocate and former UN Special Rapporteur on the Right to Health, reminded the audience on the first day.
But the ensuing discussions made it clear that many countries were under pressure not to use TRIPS flexibilities.
One issue which generated a lot of animated debate was ‘delinkage,’ a term that refers to a business model for drug development and the incentive to invest in R&D that is delinked from drug prices.
The position paper (not yet online) circulated among delegates on the eve of the conference, talks at length about the ‘Role of Innovation, Research and Development for Medical Products’. It notes that the current model of innovation in medical technologies is facing considerable challenges and that the ‘lack of transparency in providing real costs of medical research thereby leading to high costs of medical products creates access issues for the public at large.” The paper also notes that IPR is useful as an incentive but “it is debatable whether the IP system can incentivize inventions in areas where there is no market.”
Participants at the conference stressed the urgent need for a global agreement on research and development of medicines and medical products. There were several allusions to the need to foster local production, technology transfer and market entry barriers for medical products. There were charged discussions on voluntary licensing versus compulsory licensing with health activists rooting for the latter as a necessary tool to further the cause of affordable medicines.
How much of the talk will translate into action? One glaring gap at the conference was insufficient money talk on key issues.
“I am happy that the report of the UN High-Level Panel on Access to Medicines got huge play in the New Delhi conference. This will be a major contribution towards discussions in the WHO Executive Board meeting in 2018. The ideas were on the table. But what was not on the table was the money to really allow common R&D for public priorities and public use. I must also say that in discussions on trade and health, there is still an imbalance in favour of trade,” said Dreifuss.
Who is going to take the debate about delinkage forward? Many participants pointed said WHO should take up the issue. “The most pressing thing now is to have technical people flesh out the practical details of implementation,” James Love, director, Knowledge Ecology International, an NGO working on knowledge governance, told Intellectual Property Watch.
Anban Pillay, deputy director general for health regulation and compliance, South Africa Department of Health, told Intellectual Property Watch that multinational pharmaceutical companies need to be much more a part of the conversation. South Africa, he said, had adopted the voluntary licence model.
“What I would like to build on is delinkage if we agree on delinkage as a principle,” he said. “But you still have to deal with the industry no matter what the research costs are. We need to talk about what is a reasonable margin (of profit), how we can distribute this reasonable margin among different countries globally.
“Right now, the business model is to sell one’s product in high value countries, maximise profit and then think of the poor,” said Pillay. “There could be another approach. The debate on delinkage has been around for a long time. If the conversation is not with just oneself, the industry, the pharma companies, need to be on the table.”
The final outcome document from the conference is awaited. Meanwhile, India has already offered to host the 2nd World Conference on Access to Medical Products. What is needed between now and then is greater clarity on implementation and funding of the various proposals that were discussed at the Delhi meet.