Following a sustained campaign of opposition, the President-elect of the European Commission, Jean-Claude Juncker, withdrew his proposal to reassign responsibility for pharmaceutical policy to the Commission’s department for industry in the week before last. Celebrations immediately ensued amongst the public health community, which launched an energetic and well-targeted ‘thunderclap’ campaign to oppose the reassignment and successfully brought together leading voices from politics, academia and health organisations to highlight the dangers of the proposal. However, it soon became apparent that Mr Juncker’s retraction did not address the entirety of the issue. The original proposal had stated that health technologies and pharmaceutical policy would be moved to the DG for Enterprise and Industry when the new Commission began its term (which it did on Saturday 1 November). Whilst Mr Juncker’s statement confirms that pharmaceutical policy will now remain with the new DG Health and Food Safety, nothing has been said about responsibility for health technologies, leading to concern that the Commission still intends for this important area of health policy to be reallocated to the new DG Internal Market, Industry, Entrepreneurship and SMEs. The public health community has already issued an open letter demanding clarification and outlining the risks for patient safety and coherent health policy should the Commission proceed with the reallocation.
In my previous blog post outlining the original proposal to move health technologies and pharmaceutical policy, I speculated that ‘the political implications of reversing the announcement make this an unlikely outcome’. Clearly this prediction has been proven wrong. Much has been written in recent days congratulating the Commission for withdrawing the proposal (in the case of pharmaceutical policy) and rightly praising the public health community’s campaign to bring about the reversal. Very little has been said, however, about the circumstances of the Commission’s change of approach. Indeed, whilst opposition to the original proposal demanded full disclosure of the circumstances in which it emerged and detailed justification, this has been given for neither the original decision nor the subsequent reversal. The Commission has not explained why it proposed reassignment in the first place, what public health interests were served by doing so or which stakeholders were consulted in the run up to the decision. Neither has it adequately accounted for its change of heart. Addressing the European Parliament on 22 October, President-elect Juncker told MEPs ‘I have listened to you carefully’ and shortly thereafter retracted his proposal to reassign medicines and pharmaceutical products policy. But is this enough to justify such a significant reversal of policy in such a short space of time? Should we be more concerned by the error of judgement evidenced in the original proposal or the lack of commitment to it once it was adopted?
Far above and beyond the political ramifications of a presidential flip-flop, the public health implications of the prevailing proposal to reassign medical devices are cause for great concern. Medical devices policy regulates the full spectrum of devices and products used to treat European patients – from straightforward bandages and dressings to complex technologies such as MRI (magnetic resonance imaging) scanners. It also covers the manufacturing and safety of products designed for implant – the recent PIP breast implant scandal provided a stark reminder of how crucial this area of policy is for patient safety and how susceptible it is to the forces of commercial interest. Like pharmaceutical products, medical devices are too intrinsic to the health of Europeans to be considered ‘goods like any other’.
The health community’s campaign opposing reassignment, though perhaps allowing the importance of pharmaceutical policy to overshadow that of medical devices in its initial stages, was well conceived, efficiently executed and ultimately successful in ensuring that the interests of Europeans were not undermined by industry prerogatives. It must now re-focus to force the European Commission to pay its own Health in All Policies (HiAP) principle more than lip service.