Implement policies to promote health tech innovation

For decades, many international treaties and national constitutions have enshrined the fundamental right to health and the right to share in the benefits of scientific advancements. Yet, while the world is witnessing the immense potential of science and technology to advance healthcare, gaps and failures in addressing disease burdens and emerging diseases in many countries and communities remain. The misalignment between the right to health on the one hand and intellectual property and trade on the other, fuel this tension.

The UN Secretary-General established a High-Level Panel (comprising experts drawn from the public and private sector, academia, professional and civil society organisations, including people living with HIV, serving in their private capacity) to propose solutions for addressing the incoherencies between international human rights, trade, intellectual property rights and public health objectives. The panel convened in November 2015 submitted a report ‘Promoting Innovation and Access to Health Technologies’ to the UN Secretary-General and was released on September 14.

The panel has formulated a set of concrete recommendations to help improve research and development of health technologies and people’s access to vital therapies that are currently priced out of reach of patients and governments alike. The panel’s report points out that the costs of health technologies are putting a strain on both rich and poor countries.

It suggested that initially governments should form a working group to begin negotiating a code of principles for biomedical research and development, and report annually on their progress in negotiating and implementing the code in preparation for negotiating the convention.

The report also noted with grave concern that reports of governments are being subjected to undue political and economic pressure to forgo the use of WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The panel felt strongly that this pressure undermines the efforts of governments to meet their human rights and public health obligations and violates the integrity and legitimacy of the Doha Declaration.

The report noted that the WTO members must make full use of TRIPS flexibilities as reaffirmed by the Doha Declaration on TRIPS and Public Health. This is essential to promote access to health technologies. In particular, governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO members to use TRIPS flexibilities. The WTO members must register complaints against undue political and economic pressure. They need to take strong, effective measures against offending members.

Paradigm shift in transparency

Raising concerns regarding the negative impact of insufficient transparency on health technology innovation and access, the panel was also critical of the lack of transparency surrounding bilateral free trade and investment negotiations.

It observed that a paradigm shift in transparency is needed to ensure that the costs of R&D, production, marketing, and distribution, as well as the end prices of health technologies are clear to consumers and governments. Governments should require manufacturers and dis

tributors of health technologies to disclose these costs and the details of any public funding received in the development of health technologies, including tax credits, subsidies, and grants.

Reacting to the report, the global biotechnology lobbying body, Biotechnology Innovation Organisation (BIO), stated “Sadly the panel ignored the real issues that impact or delay delivery of innovative treatments and cures throughout the developing world, while focusing on policy recommendations in the one area – intellectual property – that would actually undermine ongoing research and development by hundreds of companies, universities and researchers.” 

The biopharma industry, which is spending billions of dollars on innovation and new products, continues to add that the report fails to recognise the complexity around biopharma research and development and the many efforts already taking place to advance access to care. Without the innovation incentivised through strong intellectual property protections the costly and challenging work will simply not take place.

“The report should serve as a call to action for the UN Secretary General and governments attending the UN General Assembly as they work to find global solutions to combat drug-resistant infections. It’s time for governments to implement policies and incentives that will promote health-driven innovation and improve access for people in need no matter where they live.

  Governments must go beyond the challenge of drug-resistant infections and make bold, broad reforms in the way medical research and development is conducted, so we can stop failing humanity on such a basic need,” said Doctors Without Borders/Médecins Sans Frontières (MSF), a global organisation that helps people worldwide where the need is greatest, delivering emergency medical aid to people affected by conflict, epidemics, disasters, or exclusion from healthcare.

The High-Level Panel recommended the UN General Assembly convene a Special Session no later than 2018 on health technology innovation and access to agree on strategies and an accountability framework that will accelerate efforts towards promoting innovation and ensuring access in line with the 2030 Agenda for Sustainable Development.

Impact of high cost of health technologies

Sofosbuvir is an important breakthrough in the treatment of patients with chronic hepatitis C. The problem is that one time treatment costs between 48000 and 96000 Euros. The Netherlands has been estimated 20,000 patients with this disease. The supplier defends this price in part by pointing to great value to the patient and to those affected by the patient’s illness. But such costs make healthcare unaffordable. If the Netherlands continues in this way, it will become nearly impossible to reimburse patients for these medications


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