Recap: Access to Medicines Movement Meets in Brussels
On Wednesday the 31st of January, activists, doctors, advocates, MEPs and representatives of the European Commission met in the European Parliament during an event organised by Commons Network and Health Action International.
The main topic was the system of medical research & development in the current EU framework (Horizon 2020) and the next one, FP9. What are the biggest challenges of these frameworks for access to medicines for people in Europe?
Commons Network director David Hammerstein started the day with a speech on biomedical knowledge as a commons. Other speakers included members of parliament Nessa Childers, Michele Rivasi and Lola Sanchez Caldentey, and advocates Fanny Voitzwinkler, Silvio Garattini, Ursula Theuretzbacher, Martin Pigeon, Jaume Vidal, Spring Gombe, Aude Lapprand, and Erika Dueñas.
Today, we publish the remarks by David Hammerstein and Nessa Childers.
First up, David Hammerstein’s introduction:
FROM OPEN SCIENCE TO THE COMMONS FOR BIOMEDICAL INNOVATION
Until now, most EU institutions have embraced a supply-side scientific policy where scientists, experts and academics decide with large industrial players what to research with the dominant objective of bringing the products to the market for jobs, productivity and economic growth.
This top-down “supply-side” process, that some hoped would have a “trickle down” effect, helping to alleviate inequality, support sustainability and aid international cooperation, has not been successful nor has it generated enough trust among citizens around the world in the scientific process.
The commission have proposed a new open science policy. Firstly, in our view the EU’s “openness” has to focus on addressing the great social and environmental challenges of our time with applications both on a local and global level guided by the Sustainable Development Goals of the UN subscribed by the EU: one of those great challenges is universal access to the best health-care treatments.
Today, less than 1/3 of EU research funding is devoted to societal challenges, and much of that are hand-outs to the industry disguised as “technology initiatives” like the IMI. A great deal is devoted to subsidize large multinational companies. Social challenges will not be met by market dominated “supply-side” or “top-down” or “trickle down” strategies. EU policy should be demand-driven, problem-driven, in our case, health-needs driven.
Secondly, openness must mean experimentation. New models of innovation can replace the creation of value through today’s extraction and enclosure of public generated knowledge. These new models can add value through sharing biomedical knowledge production from its inception through technology transfer into products. New forms of public-civic partnerships or public-civic-private partnerships can have public goods as output. In these new models, research is driven by universal global demand and affordable access, independence, transparency and trust are the main values.
Today the EU, under the pressure of lobbies and corporate capture, doesn’t even dare carry out experimental pilot programmes on new ways of socialization of IP, de-linkage or socially responsible licensing or supporting non-profit production of medicines, even though many EC and member state groups have recommended it.
Thirdly, “openness” must be considered as a “Commons” as a socially inclusive, democratically governed, complex and holistic tool for systemic change. Here “openness” goes beyond the positive but still inconclusive present steps of open access, open data and citizen science to a new profoundly democratic commons approach. One that includes communities of both expert, concerned non-expert and ordinary citizens. Scientific research is planned, governed, refined, developed and brought to markets, based on principles of universality, equality and trust. In the commons, we generate trust, trust that has been lost by today’s extractive rent-seeking enclosure of knowledge. This means to fundamentally challenge the taboos of IP enclosure, of health research guided by stock shareholders and double digit profits. It means challenging the tragedy of the “anti-commons”. Here we are talking about opening up science to a new social contract.
Under such governance of knowledge, the creation of value is not mainly judged by monetary criteria but by increased public health and accessible technologies. Here there is a social mutualization of production and benefits. Use value tends to take priority over exchange value in the context of the market where public-civic-private financing aims at a high level of generative return to communities in form of greater public health for longer and happier lives.
As Michel Bauwens points out how knowledge is a key part of the commons:
“Knowledge is a non- or anti-rival good which gains in use value the more it is shared. Although it can be shared easily and, when in digital form, at very low marginal cost, many extractive firms still use artificial scarcity to extract rents from the creation or use of digitized knowledge.Through legal repression or technological sabotage, naturally shareable goods are made artificially scarce so that extra profits can be generated. This is particularly grievous for life-saving or planet-regenerating technological knowledge.”
And Yokhai Benkler observes how the enclosure of knowledge is being confronted by new social commons oriented practices propelled by digital technologies:
“Patents have expanded to new domains and are given greater leeway. All these changes are skewing the institutional ecology in favor of business models and production practices that are based on exclusive proprietary claims; they are lobbied for by firms that collect large rents if these laws are expanded, followed, and enforced. Social trends in the past few years, however, are pushing in the opposite direction. These are precisely the trends of networked information economy,of nonmarket production, of an increased ethic of sharing, and an increased ambition to participate in communities of practice that produce vast quantities of information, knowledge, and culture for free use, sharing, and follow-on creation by others.The political and judicial pressures to form an institutional ecology that is decidedly tilted in favor of proprietary business models are running head-on into the emerging social practices.”
A positive note: The movement towards Open Access, open data and citizen science is transforming and broadening into the emerging practice of open scholarly communication, addressing not only publications and data, but also scholarly outreach, research assessment, online collaborative writing and even online collaborative discovery and even biomedical research, like what DNDI and the Mario Negri Institute are doing.
We hope this leads to the constitution of a scientific commons allowing the free flow of knowledge and data throughout the entire research cycle, including discovery and analysis. At every level of the scholarly process new private and/or public initiatives are in place or being created that allow the research process to be carried out differently and with efforts to capture all this in a “commons”.
Such a commons, however, as illustrated by the will to compete with private initiatives offering particular services at the different stages of the research cycle. A parallel commons power is growing! Let the commons advance!!
In a more general sense: commoning is about maintaining relationships among people, between humans and non-humans, between people and things, between past and future generations. This relational understanding of the world gives a new sense of value, helping us overcome standard economic thinking, where every thing has a price and nothing has real value, where we often fail to capture meaningful social dynamics and the satisfying connections that make life worth living.
Here are some proposals from a soon to be published Commons Network paper called “From lab to commons”
Investing in new models
The EU should carry out feasibility studies and pilot programmes into alternative business models based on universal public health needs and affordable access.
The EU and/or its member states should consider the establishment of a Cancer Innovation Fund to finance R and D, evaluate the therapeutic value, exploit the results and produce affordable cancer drugs without patent monopolies.
The EU should commit itself to the de-linkage of high medicine prices from of R and D costs, the enshrining of social conditions on public research investments, including socially responsible licensing norms for all EU research financed projects.
The EU and Member states should explore the possibility of a European Patent Pool to ensure access to for certain expensive lifesaving medicines.
EU support for the recommendations of the UN High Level Panel on Access to Medicines concerning affordability, new innovation models such as delinkage of R and D costs from end prices , a global R and D fund and much greater transparency.
Ensuring public return on public investment
The EU must take measures to guarantee a greater public return on public investments of EU research programmes, and faciltate the (open) knowledge commons with public-civic control over socially responsible licensing of research results.
EU Public-Private partnerships such as the Innovative Medicines Initiative should be reformed to assure the priority of public health objectives, public ownership of research results, affordability of final products, transparency of all research data and democratic decision making.
The EU should take the necessary measures to assure total compliance with policies for open access of scientific publications and open data of all research financed by the EU and extend these policies to EU member state financed research.
The EU should expand the Open Cloud initiative with mandatory broad-based accessible public repositories of scientific data, research results and academic articles. EU member states should mandate similar open science measures.
Public & democratic governance of knowledge
EU promotion and co-financing of publicly controlled independent Clinical Trials in key disease areas for more reliable and open evidence production on the efficacy and safety of new biomedical products.
Establishment of EU programmes for democratic and transparent bottom-up debate and decision-making by researchers, patients, health-care professionals professionals and citizens, in general, on the objectives, paradigms,v methods and ethics of of biomedical research, the exploitation of results and the affordable access to technologies.
New EU policies to mandate the transparency of prices, existing and new clinical trial data, of private R and D expenditures,and the economic relationship between health-care professionals and the pharmaceutical industry (an EU “sunshine act”).
The EU should develop new indicators of innovation and metrics of success of EU public research investments based on public health needs, affordability of health-care treatments and knowledge sharing, rather than the present predominant focus on the metrics of patents, citation in certain journals, competivity and job creation.
Trade policy, IP & policy coherence
The EU will promote an international trade policy that respects intellectual property flexibilities for the access to medicines of lower and middle income countries and will refrain from proposing TRIPS plus provisions(more stringent intellectual property rules) in bilateral trade agreements.
The EU will propose new legislation to facilitate the use of compulsory licenses, including a limitation of data exclusivity rules, by EU member states when a life saving medicine is abusively priced or otherwise unavailable to significant patient populations.
The EU should promote and regulate for scientific methodologies that produce more reliable evidence for health-care decisions:
The default regulatory path for all drugs should include rigourous testing against the best current standard of care in randomised clinical trials in order to rule in or rule out a meaningful difference in patient-centered outcomes in a representative population.
The use of surrogate endpoints and modeled measurements should only be accepted in very limited and defined circumstances.
All post market authorization trials on new products should seek to prove clinically meaningful patient-centered health outcomes (including harms) and must be carried out independently, completed and the results and methods published in full with clear penalties for non-compliance.
All clinical data on health outcomes, including quality of life, harms and survival, must be shared with Health Technology Assessment agencies, as well being available for peer evaluation and systematic reviews. EU clinical trial policy must include access to individual patient data.
And here is the text of Nessa Childers:
Timely access to affordable medicines has become increasingly difficult, and an acute problem over the past decade.
We face difficulties that, for most of Europe, used to be a matter of overseas development but are now public healthcare problems for us too.
Shortages, price hikes and the rationing of exorbitant pharmaceutical breakthroughs are a reality for European patients in the care of healthcare systems struggling under the weight of increasing costs and demands, with the inadequate resources spared by the legacy of austerity.
But this is not simply a matter of public finance capacity, even if extreme profiteering has, in some cases, turned some Pharma brands and heads as the anti-heroes of our age.
It is also a matter of how we choose to allocate these scarce resources and what returns we expect from them.
Healthcare, as we conceive of it in Europe, is not a business but a fundamental right. If we were to think of it as such, however, we won’t be hard pressed to conclude we are getting a bad deal on behalf of the citizens who pay for it and who expect affordable, good quality care in return.
Rowing against this tide can be frustrating. Last autumn, I had the honour to host the chair of the UN High Level Panel on Access to Medicines here in Parliament.
I told her of our frustrated attempts at improving transparency in the European medicines markets.
I told her of my rejected amendments to Parliament’s report on access to medicines, such as a demand to exclude price-setting and reimbursement policies by public authorities from the scope of EU trade negotiations. Same for safeguarding clinical trials or pharmacovigilance data.
Yet, here she was, armed with the knowledge and the conclusions of the high-level report.
The Dutch EU presidency in 2016 also represented a step forward, with the EU member states recognising the need to put the knowledge acquired by publicly funded research, and the dividends it yields, to more equitable and public-minded use.
Our colleague who steered Parliament’s own report on the matter also saw to it that at least some important lessons and policy goals survived the onslaught of lobbying in this house.
Those are now Parliament’s position, and we need to work to ensure that we build upon it.
Horizon 2020 can and should be improved on the biomedical research front, for public benefit.
We cannot accept the current intellectual property regime as an article of faith, when closer scrutiny reveals rent-seeking rather than innovation, and certainly shouldn’t when public money and publicly funded resources are at stake and private profits are being made.
This is how we ended up with serious under-investment and unmet needs in areas that are not profitable or fraught with uncertainty as to their outcomes.
Neglected diseases, poverty-related diseases or anti-microbial resistance are some of the areas which are seriously in need of alternative, needs-driven approaches to innovation.
The alternatives needn’t even be mutually exclusive, but they’ll certainly beat what we have now, which we can describe as a monopoly on the very idea of innovation, with public money siphoned into monopoly profits.
Transparency is currently lacking throughout the research and development process. We need access to information not only in terms of, say, clinical trials, but also licencing terms.
We would benefit from a consolidated, publicly accessible register for biomedical research where the overall purpose and objectives of studies are logged beforehand, and checked against a positive or negative outcome, so we could mitigate publication bias and avoid redundancy.
Public-Private Partnerships need to disclose enough information regarding the terms reached between the parties to allow us to gauge whether the public interest is safeguarded in terms of the goals and the outcomes of undertakings.