In November 2009, following a sustained campaign by health actors and against strong opposition from the pharmaceutical industry, responsibility for EU policy on health technologies and pharmaceuticals was moved under the purview of the Directorate General (DG) for Health and Consumer Policy (SANCO). On 10 September 2014, the President-elect of the new European Commission, Jean-Claude Juncker, announced a reversal of this decision, placing the portfolio (back) under the direction of the re-structured DG Internal Market, Industry, Entrepreneurship and SMEs.
Health technologies and pharmaceutical policy is a field which, at the European level, involves the regulation of medicines for human and veterinary use, the production of medical devices, the development of new drugs for rare and communicable diseases, the operation of the European Medicines Agency (EMA) and many other vital elements of European health systems.
The Commission’s announcement has drawn fierce criticism from public health advocates concerned that is poses a threat to the unity of European health policy. The European Public Health Alliance (EPHA) warns of ‘potential disaster’ and damage to health leadership in health emergencies, such as the H1N1 virus, which was the primary motive for reassigning responsibility in 2009. Health Action International (HAI) highlights the danger of regulatory-capture which is inherent in bringing the EMA under the direction of the DG responsible for the interests of those it regulates. Meanwhile, Jim Murray, a former director of the European Consumers Organisation (BEUC), urges the Commission to re-think its decision before the new structure is put into place to prevent loss of clarity and clash of interests in public health policy.
Health is a field unlike any other, in that it could feasibly be assigned to almost any of the Commission’s 27 portfolios. Health is affected by policy in trade, competition, agriculture, social security coordination, occupational health and safety, employment, economic growth, migration, environment and many other fields. This is the core notion behind the EU’s Health in All Policies (HiAP) principle; since all policies affect health, health must be taken into consideration in all policies. HiAP also means that it is necessary to involve other DGs in the governance of health. The production and distribution of food, for example, is a vital component of national health systems but is largely the purview of DG Agriculture. Similarly, Europe’s pharmaceutical industry was responsible for an estimated €316.5 billion of exports in 2013 – as such, it is logical that some elements of pharmaceutical policy might need to involve DG Trade.
Collaborative governance is vital for good public health policy, but the understanding that sectors outside of health have a role to play should not be misinterpreted to mean that interests outside of health should be served on an equal basis, much less that they can be served by the same regulatory structure.
The responses of the public health community illustrate the plethora of issues which arise from designating a single DG responsible for promoting both public health and pharmaceutical industry interests. In addition to policy concerns around the management of health emergencies and access to essential medicines, the decision is bad for competition, innovation and, ultimately, growth in the pharmaceutical industry. The current model of R&D encourages the production of profit-generating ‘me-too’ drugs which offer no added therapeutic value to the patient but which preserve patent-level prices for high-consumption medicines – often those for the treatment of ‘lifestyle conditions’ rather than serious illness. This is a model based upon the interests of big business. Only when these are balanced with the interests of public health will the industry be prompted to develop drugs which fulfil unmet medical needs and serve wider societal interests.
More fundamentally, the decision has undermined confidence in the governance process; made without public debate, justification or apparent motive, it was also announced after the European Parliament’s deadline for submitting written questions to be put to the nominated Commissioners. This kind of secretive, elite governance could not come at a worse time. Economic recession, austerity politics and falling standards of living have bred disenchantment, Euroscepticism and unrest amongst Europeans – perspectives which can only be altered by ensuring open, transparent and democratic decision-making.
Whilst Mr Murray’s call for the Commission to re-think its choice is laudable, the political implications of reversing the announcement make this an unlikely outcome. It is already affecting the broader governance of health – on 12 September, EPHA was forced to withdraw its support from the European Parliament’s proposed Health for Citizens Intergroup, since its composition and functioning will no longer be in line with EPHA’s core values. In addition to harming public health outcomes and the well-being of European citizens, the reassignment is a disaster for progress in health and broader EU governance. The Commission’s White Paper on European Governance highlighted the need for ‘greater openness, accountability and responsibility’ in the policy-making process. This latest decision honours neither the conclusions of the White Paper nor the HiAP principle.