In 2016, there will be unparalleled attention on the issues of access to advanced medicines and how to pay for them. Past controversies have largely focused 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

The background is probably familiar:

  • Continuing disquiet over the cost of new hepatitis C treatments (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 -- in common cancers such as non-small cell lung.
  • A series of highly contentious increases in the cost of orphan drugs in the US.
  • Moves by China to increase the credible threat of compulsory licences if price negotiations fail.
  • The effective end of the Doha Round of world trade talks and its impact on IP issues.
  • In its 70th year, a call at the last UNGA by major donor countries 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, especially in the health sector.

Why 2016 will be busy

It will be difficult for any one company to track everything that is likely to happen in 2016, and impossible for trade groups to do so as most of the developments are taking place away from traditional centres in Geneva and New York. 

  • 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. Anti-industry activists 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). UNDP is providing the secretariat and several of the panel members served on an earlier UNDP Commission that was highly hostile to IP.
    • A report is due in June 2016 (at the start of the Northern Hemisphere's media silly season), which would give middle-income countries a chance to promote it and then bring forward a General Assembly resolution based on the findings.
    • Stakeholders have until the 18th of February to 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 more about intellectual property than they do about any specific health threat (despite the efforts of several countries, this wording survived into the main text: “provide access to affordable essential medicines and vaccines, in accordance with the 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 Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.”)
  • After the Nairobi trade talks, the USTR 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." PhRMA and IFPMA will look at the continuing negotiations but will find it difficult to track 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 European Union is with The Netherlands until the end of June (and from July with 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 and ....[may]  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 industry sectors such as food and beverages but has, we were told by a senior OECD official, been largely ignored by the pharma industry, 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 science companies and some biotechs. But few U.S. 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. 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?

Ward Health, as part of the Baird’s CMC global network, has put together a team which can help monitor every aspect of developments throughout this very busy year and can help you to provide information and perspectives to those working in each of the tracks. 

  • The core Baird’s CMC team has worked on policy and communications projects involving innovation, intellectual property and middle income countries free riding for over 15 years. We have expert shareholders in France, Germany, the UK and the USA and in Brazil, India, Russia and South Africa (and 25 other expert shareholders around the world). 
  • Chitra Subramanian and CSD Consulting in Geneva brings very detailed knowledge of the WHO, WTO and Geneva public health community as well as unparalleled access to relevant Indian policy makers and influencers. She has followed the Uruguay Round of trade talks from start to finish. She also has access to key WTO negotiators in Geneva as well as human rights activists and jurists.
  • We have experienced implementation partners with excellent policy analysis skills in China, in Indonesia and in other countries that are likely to be important in 2015 -- such as Colombia (a future OECD member which has taken a strong stance on drug pricing in several international forums) and the Netherlands (which has the rotating presidency of the EU in the first half of 2016). 
  • Several of our shareholders own or are co-owners of companies which bring additional skills to our network. 
    • Chris Ward worked at PhRMA for many years and was, before that, with the group representing Canadian R&D-based companies. He now runs Ward Health.
    • Martina Dörmann has worked on trade, pricing and formulary issues in Germany and throughout Europe for over 15 years. She is the Managing Director of IPSE.
    • Mark Chataway has worked on issues of access to medicine for clients including foundations, inter-governmental organisations, governments, companies and the Global Health CEO Roundtable. He is the Director of Hyderus.


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