Access to advanced medicines and affordability: a look forward to 2016
We think that there will be unparalleled attention in 2016 on the issues of access to advanced medicines and on how to pay for them. Past controversies have largely focussed on access in low and middle income countries; this time Europe and North America will command at least as much attention. Ironically, the world’s richest and the poorest will face the same problem – who pays, for what, how and why?
The legacy of 2015 on access to advanced medicines
The background noise is high
- continuing disquiet over the cost of new hepatitis C treatments in Europe and North America (although much less attention has been given to the market forces which have driven down prices everywhere)
- immunotherapy and combination treatments in cancer which probably offer significant survival benefits — maybe even long-term remission for some patients — in common cancers such as non-small-cell lung
- concern over rising co-payments for US patients in even conservative newspapers
- a series of highly contentious US increases in the cost of orphan drugs. This article gives a how-to for biotech companies on using the Orphan Drug Act
- threatening noises from China which increase the credible threat of compulsory licences if price negotiations on cancer medicines fail (the link is in Chinese — we don’t know of an official English translation)
- the effective end of the Doha Round of world trade talks and its impact on IP issues — for an activist review of the Nairobi summit, see here
- in its 70th year, a call at the last UN General Assembly by the UN Elders (which includes South Africa’s Archbishop Desmond Tutu; former Norwegian Prime Minister and WHO head, Dr. Gro Harlem Brundtland; former Irish President Mary Robinson and; former US President Jimmy Carter) asking the UN to rethink and remake itself to give greater access to civil society groups
- activists are learning from getting things right. At the December 2015 climate change summit, COP21, the absence of trust affected funding mechanisms. Unlike countries speaking at cross purposes (many of which came to Paris unprepared), civil society groups have been rightfully focussed and organised in asking for “equity and justice”. This will grow.
Why 2016 will be exceptional
It will be difficult for anyone to track everything that is likely to happen in 2016
- In late November 2015, the UN Secretary-General convened a high-level panel on health technology innovation and access. The only multi-national pharmaceutical company representative is Sir Andrew Witty of GSK. Dr Yusuf Hamied of Cipla also sits on the panel. Several stakeholders are notably absent: the IFPMA, the Patent Pool and the WHO, for example. Civil society groups that have been highly critical of the R&D-based pharmaceutical industry are strongly represented. The likely drivers of the panel are Brazil (represented by a former WTO ambassador and by a senior executive at a parastatal producer of biologicals and small molecules) and South Africa (represented by the Director-General of the country’s Department of Health). Both countries are committed to improving access to advanced medicines and other treatments for non-communicable diseases
- UNDP is providing the secretariat and several of the panel members served on an earlier UNDP Commission that was often hostile to pharmaceutical patents: one of its working papers said, “When voluntary licences are not forthcoming or refused or when the licences involve minimal technology transfer and capacity building, government and private entities can consider compulsory licensing alternatives, especially if there is an access/affordability issue. If the government has adopted easy-to-use compulsory licensing procedures, then private interests, including but not limited to generic producers, can take the initiative to promote competition”. (In fairness, the Commission tackled lots of thorny issues such as gay men in the Arab world or cultural practices and human rights and was never afraid to be forthright)
- A report is due in June 2016 and will probably play out in the media at the beginning of the summer in the northern hemisphere – when newsrooms are dry. It will very likely be pitched as a poor countries versus rich countries issue, making for sensational headlines. The timing will give middle-income countries a chance to bring forward a General Assembly resolution based on the findings. There is talk of launching a “People’s Health Movement” during the UNGA. Some patient groups are concerned that the discourse may become overly ideological
- Stakeholders have until the 18th of February to be ask to make a contribution that addresses “the misalignment between the rights of inventors, international human rights law, trade rules and public health where it impedes the innovation of and access to health technologies … Shortlisted contributors will be invited to present and engage members of the High-Level Panel on their contributions at one of two Hearings, at locations and dates in March 2016 to be advised. The Secretariat will pay for the travel of the individual”
- The General Assembly will also receive a list of over 200 proposed indicators on progress towards the newly-adopted Sustainable Development Goals. This is due to be finalised by the March meeting of the UN Statistical Commission but some of the indicators may take longer. We should expect several to focus on non-communicable disease in lower and middle income countries. The SDGs themselves contain specific language on intellectual property and health (for example, speaking about “the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all”). Many hope that the indicators will include ambitious targets on tobacco, abuse of alcohol and the promotion of unhealthy foods and beverages
- After the Nairobi trade talks, the US Trade Representative noted, that WTO members “will be freed to consider new approaches to pressing unresolved issues and begin evaluating new issues for the organization to consider” It will take experienced and informed in-country experts to understand what civil society, media and politicians are doing in Brazil, China, India and other major developing economies
- Surprising research has gone largely unreported. A paper in January’s American Economic Review (subscription required) looked at the impact of tougher patents in India after the country’s accession to the WTO in 2005. The researchers found that, “new product patents increased prices, but the magnitude of the change was ultimately quite small …. [and there was] little change in the quantity sold as a result of these price increases.”
- The rotating Presidency of the Council European Union is held by The Netherlands until the end of June (and from July by Slovakia as part of the same group of three countries which co-ordinate their agendas). Dutch Health Minister, Edith Schippers has said that their Presidency will focus on European cooperation on drug prices. The official 18-month programme of the leadership troika says, “The three Presidencies will take forward discussions on ways to improve the health status of the EU population, by fighting noncommunicable diseases, the availability of and access to innovative and affordable medicines for patients as well as cooperation between Member States’ health systems”
Belgium and The Netherlands are experimenting with pooled procurement for orphan drugs. The European Haemophilia Consortium says that, “other Health Ministers displayed their interest in the programme. The Health Ministers from Belgium and the Netherlands have expressed their hope that other countries will join the initiative after the pilot project.”
Médecins Sans Frontières (MSF) is hiring a new EU Policy & Advocacy Advisor to focus on the EU institutions. MSF’s focus will always be lower and lower-middle income countries. It wants the new hire to, “Advise on and then implement actions and strategies to influence policies that may be detrimental for access to medicines and to promote positive measures to improve access and innovation for medical tools at the EU level”
- The Secretary General of the OECD wrote last year, “In early 2017, the OECD will be convening a meeting of OECD Ministers of Health in Paris to discuss how health systems can best adapt to meet the challenges of the future. At a time of rapidly evolving demand and scarce resources, the need for the OECD’s mission of better data, better analysis and better policies for better lives has never been greater.” This health ministers’ meeting has been the focus of intensive preparation work by some industry sectors but has been largely ignored by both the pharma industry and key civil society organisations although a central OECD task will be to consider, “ways of managing the use of …. often very expensive [pharmaceutical and new] technologies, at an appropriate cost”
GSK is the only R&D-based multinational pharma company represented at a high-level on either the Secretary-General’s panel or on the Healthcare Working Group of the Business and Industry Advisory Committee of the OECD. It’s an excellent company and its presence indicates the depth of its thinking on these issues. However, its views on IP issues are often at variance with those of some other companies. For example, in a 2014 Chatham House paper on antimicrobial resistance, Kevin Outterson, an academic at Boston University, wrote, “GlaxoSmithKline outlines a valuable framework for full delinkage [of R&D from sales]. The drugs are provided at marginal cost to payers (and perhaps lower to consumers at the point of care) with all company profits deriving from a very significant government-funded income stream.” Outterson points out that the GSK position on AMR is shared by many other European life sciences companies and some biotechs. But few US companies would have presented that outline.The typical critique of GSK is sometimes unfair (this 2015 Forbes article gives a flavour of the genre) but GSK’s business model is much more diversified and somewhat lower risk than that of most of the rest of the industry. The Financial Times Lex Column said late last year that the major risk against which GSK had hedged was pressure on prices in the developed economies. As the Forbes piece points out, GSK is also ready to try radical experiments to make innovative medicines affordable in middle-income countries.
How can we help?
We have put together a team which can help monitor every aspect of developments throughout this very busy year. We can also help inform policy makers and policy influencers involved in each of the processes. Our existing clients, on a range of projects, include governments, multilateral organisations, multinational companies, NGOs, foundations and patient groups. We have over fifteen years work in policy and specialised qualitative market research on health and access issues. We have developed strategy and internal training plans for major foundations, governments and at least half of the biggest ten global pharmaceutical companies.
We have expert colleagues in every major centre of activity: Brazil, China, France, Germany, India, South Africa, the UK and the USA for example. Our new partnership in Geneva gives us top-level analysis of trade and global health issues. We also have experienced partners in emerging centres of activity on these issues such as Colombia and Indonesia.