Below is a short summary of my talk at the event "Health for sale", The Hague, February 6th, 2016
The EU can take the lead for affordability, openness and accessibility
The present model of biomedical innovation is morally unacceptable because it cannot be universalized to permit affordable, effective and safe health treatments for the vast majority of the world´s population. The principles of a new model that considers health a common good must be based on transparency, scientific openness and sharing, affordability and guarantees for a much greater social return on public expenditures. These principles can be advanced by a general reconsideration of patent monopolies as the main drivers of innovation, the promotion of new, health-needs-oriented r and d incentives and the promotion of a new fair social contract between citizens, patients, public and private health insurers and industry.
The main indicators of success of biomedical innovation must be universal access, efficacy, safety and affordability not the level of profits for shareholders (Big pharma is among the the industrial sectors with the highest level of profits). Enormous profits based on high prices that exclude most of the world´s population cannot be the source of innovation. On the contrary, much greater investment and sharing in the fields of global public health and environment health is a moral obligation for the common good and one of the most responsible ways of responding to a world full of growing existential dangers fueled by stark inequality, climate change and national/ethnic conflicts.
The EU can take the lead for positive change. EU policymakers are in the position to take some concrete steps such as: pilot programmes on alternative R and D models, the expansion of the “Horizon Prizes” within the Horizon 2020 programme for medical innovation inducement with cession of IPR rights, a socially-responsible licensing policy to assure affordability when EU R and D funding is involved, the consolidation of clinical trial transparency, open access and open data measures, the reform of the Innovative Medicines Initiative to assure the health-driven defense of the public interest and democratic plurality, the development of an EU public platform for the development of affordable and universally accessible new generation of antibiotics to be able to bring them out as generics from the first day, EU support for a global R and D Treaty at the World Health Organization that promotes new socially-responsible models of innovation and the withdrawal of any EU bilateral trade proposal that could harm affordability, transparency and accessibility to medicines. Other EU measures could include a European “sunshine act” to prevent conflicts of interests between pharma and health professionals, a mandatory transparency regulation to reveal pharmaceutical R and D costs and financing, the promotion of joint procurement between EU states and greater political flexibility (limiting data exclusivity rules) to permit compulsory licensing of very expensive, life-saving medicines in EU member states. In general, there is an imperative for much greater North-South transfer of health-related technology and knowledge. Tighter enclosures and higher walls around our opulent, satisfied Europe could very well be a recipe for disaster in the future. Solidarity, openness and sharing on all fronts is a morally clear path for mitigating suffering, exclusion and inequality that might very will impact us all sooner than we think.
Some positive proposals for access to medicines in the EU recently made by the S and D (Socialist) group of the European Parliament:
Encourage joint procurement of vaccines and other medicinal products by Member States, which would strengthen their negotiating power driving down purchasing prices, thus providing lower costs for patients.
Call for a new Transparency Directive following the withdrawal of Directive 89/105/EEC, that aims to ensure the transparency of measures established by EU countries to control the pricing and reimbursement of medicinal products.
Call on drug developers to respect transparency in the production costs of medicines, in order to understand the proportion of R&D investment reflected in the purchase price, with a view to ensuring the right balance between a fair price for patients and a fair return on investment for industry.
Ensure easy public access to data on all clinical trials carried out for new and existing medicines in line with the revised Clinical Trials Regulation.
Stimulate competition between generic medicines and established medicines where the patent has expired, which can incentivise innovation and reduce l the costs of pharmaceuticals.
Take measures to ensure that generic medicines are not being unfairly prevented from entering the market by big pharma.
Rethink patenting rules to find a way to incentivise and finance R&D, as investment by industry tends to focus on areas where a return can be expected.
Consider alternative incentive models such as prizes and conditional public funding.
Introduce conditions such as affordable pricing and non-exclusive licencing if a large share of R&D needed to develop a new medicinal product is publicly funded.
Gather statistics on the proportion of funding provided by public, industrial and philanthropic sources to pharmaceutical R&D.
Consider establishing conditionality within the Horizon 2020; claim co-ownership of IP for projects funded by EU grants.
Monitor whether patents are granted for genuine innovation; examine the practice of ‘evergreening’, where pharmaceutical companies get patents for inventions that are not actually new, but are ‘old science’ with minor modifications to existing products in order to keep their patents indefinitely.
Defend the independence and transparency of EMA in the assessment and approval of medicines so as to ensure high quality, safety and efficiency.
Support cooperation through the Health Technology Assessment networks to identify the safest and most clinically effective treatments.
Develop a European framework, in line with Article 15 of Directive 2011/24/EU, to provide reliable, timely, transparent, comparable and transferable information on the relative efficacy of health technologies to support Member States’ decisions