Potential Limits of the European Union’s new Pharmaceutical Strategy
By: Tiyash Banerjee, The City Law School, City, University of London
On 25th November 2020, the Commission adopted a Pharmaceutical Strategy for Europe. This Pharmaceutical Strategy is underpinned by four main objectives:
- Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
- Supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and greener medicines
- Enhancing crisis preparedness and response mechanisms, and addressing security of supply;
- Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.
The Pharmaceutical Strategy is multi-faceted, with various aspects to be rolled out over the coming years. This includes a reconsideration of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use which establishes the European Medicines Agency.
The Inception Impact Assessment recognises the need to have a “future-proof and crisis-proof system to ensure timely access to safe, quality and affordable medicines under all circumstances.” The Pharmaceutical Strategy is informed both by the coronavirus pandemic and the ageing population of the EU. Lessons learned from the pandemic can be seen through proposals to reduce the time it takes to gain regulatory approval for new pharmaceuticals and vaccines. These proposals should not be misconstrued as short-cuts, as was often argued during the pandemic. Working more efficiently in the regulation of medicines and medical devices, whilst also maintaining high standards of regulation, can have significant medical benefits.
The aims, and reception, of this Strategy are well-reflected by the public consultation on the ‘Evaluation and revision of the general pharmaceutical legislation’ which was accessible between 28 September and 21 December 2021. The Commission review of the Public Consultation identified 16 key themes which emerged through analysis of the 478 consultation responses.
These were: 1) Future proofing to address emerging technological developments; 2) Incentive system; 3) Rationalising/simplifying the regulatory system; 4) Safeguarding public health 5) Functioning of the EU market; 6) Alignment with other EU legislation (coherence); 7) Access to medicines; 8) Continued relevance of the legislation; 9) Security of medicines supply; 10) Engagement of Health Technology Assessment (HTA) agencies, healthcare professionals and patients; 11) Harmonisation of evidence requirements by European Medicines Agency (EMA), HTA authorities and pricing and reimbursement bodies; 12) End-to-end transparency; 13) Environmental impact; 14) Global health; 15) Publicly-funded medicine development; 16) Other.
Of these concerns, the fourth seems to be one of the most significant: any EU strategy must safeguard the public health of all who are in the EU.
The Strategy is ambitious, primarily with regard to medical and economic developments, but risks overlooking important aspects. The proposals seem to focus on motivating innovation and creating regulatory attractiveness, yet these cannot be achieved without adequately considering patient safety. Whilst patients’ interests are considered with regards to unequal access to affordable medicines, balancing patient safety does not feature prominently enough in the proposals for innovation.
Further, the Strategy reflects a focus on industry rather than recognising the broader processes of pharmaceutical development. Whilst recognising the value of medical developments and the potential for economic growth, the Strategy understates the role of non-profit parties such as academia and research institutes, where instead it should be promoting these through research funding.
The Pharmaceutical Strategy proposes a number of interesting policies, modernising the existing regime with an ambitious approach to medical innovation. It is important however that innovation and market concerns are considered in line with the underpinning objective of patient safety. Scientific progress must also be recognised within the academic context, rather than an exclusively market-based one.