Bracing for another delay - opening up innovation for medicines.

Open innovation, open access, crowd-sourcing innovation, innovation prizes.... All buzzwords we often hear in the media, employed by entrepreneurs, government officials or science journalists. The terms have become part of the discourse on innovation and science: companies crowd source their data and innovation, governments are opening up their data to allow for civic participation in innovation, open access publishing is gaining major ground, the US government now mandates it where government grants are involved. Various ideas and arguments play a role here.  Moral arguments about social justice and public goods are certainly important, but so are ideas on effectiveness and models of innovation.  Although many people have been working on open innovation initiatives for many years, the familiarity of these terms is a pretty recent phenomenon. 

UN institutions are usually not associated with cutting edge ideas.  Yet the World Health Organisation was actually ahead of the curve, its member states were discussing open innovation ideas on research and development for medicines a decade ago.

Why? Because it is urgent, because people are sick and dying, because the current bio-medical innovation system is unjustifiable.  The health R&D system excludes a large part of the world population in its business model and does not provide the innovation where its most needed. It focuses on wealthy markets and the pharmaceutical industry can charge monopoly prices on life saving medicines, their markets being protected by intellectual property rights. It is not so much up to companies to change this; they are merely agents limited in their outlook trying to maximize profits. It is up to countries and international governmental organisations to change the incentives and institutional framework for health R&D. Unfortunately, the World Health Organisations is no longer ahead of the curve, it has not been able to do anything substantial with proposals on new open models of innovation.

At the World Health Assembly this year, delegates from countries all over the world will come together to discuss an agenda that ranges from discussion on universal health coverage to health in Palestinian territories and WHO Reform.  One of the agenda items to be discussed is a Global framework for health R&D – finding a comprehensive solution to the broken research and development system. A system which excludes so many and innovates so little where it is really needed.

There is a wealth of ideas for the architecture and features of such a framework. The best proposals include open innovation approaches and the sharing of knowledge, where medicines are created as global public goods accessible to all.  After years of negotiations and struggle, industry influence scandals, reports and country consultations, a special high level expert commission looked at proposals and produced a report.  They recommended negotiations for a binding convention to start, they recommended ingraining open knowledge innovation and affordable access to resulting products into any roadmap countries agreed to, and they recommended more.

The thing is, vested interests are pretty happy with the status quo and are not about to let the health R&D system move to the 21^st century. So they are holding on, delaying, having the EU & US drag their feet and even sabotage the process - as reported in the Atlantic this month. Not always with good arguments,  but always with strong bargaining powers. This year again at the end of May, we brace ourselves for more unimaginable non- ambition of Member States and the WHO which do have the joint responsibility for the health of all world citizens. We do hope that finally some meaningful steps will be taken towards a structural solution.

Sophie Bloemen – Advisor to Health Action International

Staff Blog has been revived!

The HAI Europe staff blog has been revived! From now on, HAI Europe staff will keep you posted on the most recent political developments and events on access to medicines on this blog.

You can also follow HAI Europe on Facebook page or on @HAIEurope on Twitter to keep up to date on the latest development in HAI Europe's projects. All our publications can also be found on our website.

The HAI Europe staff

EU Policy Opportunities in Biomedical Innovation and the Public Good

Together with the Trans Atlantic Consumer Dialogue (TACD), HAI Europe is currently finalising a policy paper on biomedical innovation for the European level. Sophie Bloemen and David Hammerstein are now making the last edits to the paper and it should be out soon. At our conference in the European Parliament: Horizon 2020: Investing in the Common Good on November 30, we took the opportunity to introduce the policy paper with an Executive Summary to all participants. Some key points of the Summary are covered below.

The current model of biomedical innovation tends to enclose knowledge using intellectual property (IP) rights that are meant to be rewarded in exchange for innovation. However, driven by today’s social and economic reality this model of innovation often fails to take into account economic sustainability, does not always deliver needs-oriented innovation, and tends to neglect the least wealthy parts of the world’s population including many European Union (EU) citizens. The Horizon 2020 EU Research and Innovation Framework provides the EU with an opportunity to make socially responsible choices that lead to new sustainable models of innovation which contribute to the common good.

In light of Horizon 2020 and the Innovation Union agenda, this Policy Brief offers an overview of the most important contemporary discussions, initiatives and proposals on biomedical innovation, and provides recommendations to European institutions on how to become leaders in exploring new and complementary models of innovation, establishing a truly innovative research agenda while implementing their commitments to Health Equity within the EU and to Global Health. Business as usual is no longer an option.

Various proposals and projects have been developed by governments, civil society, academics and industry which promote access and innovation. These include;

Socially responsible IP management or Equitable licensing

Open Source research

Voluntary licenses to the Medicines Patent Pool

Product Development Partnerships (PDPs)

Innovation inducement prizes

Intergovernmental Instrument on Coordinating & Financing of Biomedical R & D

The EU´s Horizon 2020 project should condition any release of knowledge property to a business plan that conforms to ethical, social and environmental objectives in accordance with the public interest. Furthermore, for the EU to be a leader in technological innovation, it needs to take a broader perspective and look at key developments in open source research and open medicine. The upcoming Horizon 2020 EU Research and Innovation Framework provides the EU with an opportunity to make socially responsible choices that lead to new sustainable models of innovation which contribute to the common good.

The full Executive Summary can be found here.

Statement on Medicines Patent Pool

HAI Global and HAI Europe congratulate the Medicines Patent Pool (MPP) on the licensing agreement with generic companies, most notably Aurobindo. The sublicenses are a major step forward in the development of an effective MPP and will have a tangible impact on the lives of many patients and promise the prospect of real improvements in global Access to Medicines.

While acknowledging that these licences are an important step forward, with the potential to deliver real improvements in global Access to medicines, HAI also supports efforts for an inclusive and transparent dialogue with MPP, in order to ensure that persons living with HIV, the broader public health community and the MPP work together, and that everyone has an opportunity to be informed and consulted on core policy choices.

We have followed the discussion on the MPP Gilead licence and have been saddened at the discord to which it has led, both in and between the Access to Medicines network. There is no doubt that the opinions on the DPP differ; even within the HAI network we acknowledge disagreement on the MPP mechanism and its worth. We also recognize that there are outstanding issues and questions on the MPP and the Gilead licence, for example we are particularly disappointed the licence terms limit production to India.

Despite differences on specific substantive and process isuess, HAI has confidence in the competence and integrity of the MPP Staff and Board, and sees value in the MPP as one of several mechanisms to improve public health and bring greater transparency to the patent system. As part of international civil society, HAI will continue to campaign for strategies alongside the MPP, like supporting the use of TRIPS flexibilities and opposing TRIPS plus trade policies, addressing conditions and circumstance that cannot be addressed by the MPP. HAI will also continue to follow broader voluntary licence trends, such as opaque licensing negotiations between companies that exclude other stakeholders and we will campaign for alternative R&D models and incentives that de-link the cost of R&D from the price of the product. However, the MPP is an important contribution to contemporaneous access issues whilst we work towards perfect solutions.

There is a need for constructive dialogue between all stakeholders around the MPP issues in contention, without it frustrating or derailing the efforts of the MPP team in bringing us to this point. An informed and critical content discussion with MPP is important and should lead to improvement. What should be avoided is an accusative and aggressive tone which is unnecessary and not conducive to further fruitful cooperation on Access to Medicines. It will take time to have a clear view on the contributions and faults of the MPP, and critical voices from different regions will help the pool to develop. For now though, we are impressed by what the MPP staff has achieved and are anxious to see how it further develops.

Tim Reed HAI Global

Sophie Bloemen HAI Europe

Public Event on EU-MERCOSUR in Buenos Aires

On Friday the 29th of July the first public event on the MERCOSUR-EU negotiations took place in the University of Buenos Aires, Argentina. Organized by the research institute CEIDIE, speakers included public officials from several ministries, academics such as Carlos Correa, Sandra Negro and Xavier Seuba, as well as representatives from the civil society (ABIA and HAI Europe).

Speakers discussed the background and the current state of the negotiations, as well as the prospective goals envisaged by the parties. Particular attention was devoted to agriculture and intellectual property. The event discussed the significant differences in approach and the difficulties to be overcome, with a view put on the public interest and development concerns.

Civil society presented its concerns with regards to public health and access to medicines and the possible role of the European Parliament in the negotiations.

With respect to intellectual property, fundamental differences between the parties were raised. Dr. Correa put the agreement in the context of the ever-increasing level of demands, while X. Seuba pointed out that in fact parties where not negotiating an IP chapter, but exchanging views on the role of intellectual property on economy and society.

The next round of negotiations will take place in November in Uruguay.

Sophie Bloemen

Study provides recommendations on European Medicines Agency's communication on medicines

A recently published study produced by an independent expert offers recommendations to assist the European Medicines Agency's communication on the benefits and risks of medicines.

The report is a result of a year long project carried out by Dr Frederic Bouder and aims to provide evidence based input.

The study not only contains a detailed analysis of the expectations and attitudes of the different stakeholders of the agency regarding its communication on medicines but also draws up detailed recommendations for the agency such as the setting up of a risk communication advisory board.

The report further recommends the involvement of patients in communication activities, a review of the handling of its communication tools and to shape a strategic view on transparency.

The agency has already implemented some of the suggested recommendations.

Read the entire report here

The Diagnosis of Childhood Bipolar Disease has led to Catastrophic Consequences

There has been a call for the diagnosis of childhood bipolar disease to be axed from the Diagnostic and Statistical Manual of Mental Disorders (DSM) by one of its early editors. Experts argue that Bipolar disease emerges in early adolescence, no sooner. Jon Ronson reports in this month’s edition of the New Scientist on the controversial condition.

The DSM offers a checklist of symptoms to help diagnose psychiatric illnesses. The ever-expanding index of the manual is said to be an attribute of society’s perception of what is normal behaviour; further influence stemming from the pharmaceutical industry and patients groups.

Mr. Frances Allen, former editor of the DSM, is now critical of aspects of the diagnostic tool, stating that the inclusion of Childhood Bipolar disease was a mistake. Tragically, in the United States, a four year old child died after receiving a fatal dose of her prescribed medication to treat the disease. Her parents administered the bipolar medication whenever the child was “being annoying”.

HAI Europe advocates the rational use of medicines and will be addressing issues relating to conflicts on interest and psychiatric medicines at an open-seminar: Mad Medicine: Are conflicts of interest driving you crazy? It will be held in Cork, Ireland, on the 24^th of September, 2011. Please contact Lorraine at events@haieurope.org for further information.