European Commission Presents Pharmaceutical Strategy for Europe
On 25 November 2020, the European Commission (the Commission) unveiled its Pharmaceutical Strategy for Europe (PSE), a wide-ranging document that discusses a series of broad policy statements, tentative considerations and concrete measures to tackle the many challenges faced by the pharmaceutical sector and its diverse stakeholders (see, attached Commission Communication (2020) 761 final; Commission press release; and Commission Q&A). The announcement follows an extensive period of consultation, study and preparation (see, Van Bael & Bellis Life Sciences News Alerts of 20 October 2020; 12 August 2020; 17 June 2020; 3 June 2020; and 28 May 2020).
According to the Commission, the PSE is built on four pillars, each of which covers a large terrain of its own.
1. Ensuring patients accessibility and affordability of medicines
Unmet medical needs
The PSE will focus on a range of unmet medical needs. Chief among these is the development of novel antimicrobials against the backdrop of the sustained fight against antimicrobial resistance. Other important policy areas are those of medicines for children and rare diseases. The existing regulatory framework will be revised.
Patient access to medicines
While the objective to improve patient access to medicines is universally acclaimed, there is less consensus regarding the means to achieve that goal. The pharmaceutical industry is wary of the supposed need to “revise the system of incentives and obligations in the pharmaceutical legislation taking into account the relationship with intellectual property rights” (PSE, p. 8). Similarly, plans to “understand better the root causes of deferred market launches” (PSE, p. 7) and “improve access to generic and biosimilar medicines, including interchangeability and the “Bolar” exemption” (which shields from patent infringement specific tests and trials for generics and biosimilars necessary for obtaining marketing authorisation) (PSE, p. 8), meet with great suspicion.
Affordability of medicines
This is an area largely reserved to the Member States. Still, the Commission says it will “foster transparency of price information to help Member States take better pricing and reimbursement decisions” (PSE, p. 8). This may take the form of guidelines for establishing the R&D costs of medicines (PSE, p. 9) and may pave the way for measures such as that adopted earlier this week in France to require applicants for the reimbursement of their medicines to disclose any public funding received in product development. The Commission also plans to spread knowledge on matters such as health technology assessment; savings derived from generics and biosimilars; responsible prescribing; and improved patient adherence (PSE, p. 9) and it will generally encourage cooperation on pricing, payment and the procurement of medicines (PSE, p. 9).
2. Supporting a competitive, innovative and sustainable European pharmaceutical industry
Creating a fertile environment for the European pharmaceutical industry
The adoption of the PSE coincides with further major policy initiatives in areas with an immediate bearing on the pharmaceutical industry involving intellectual property and data governance. In these categories, the Commission will revise the medicine-specific patent protection afforded by Supplementary Protection Certificates and propose legislation creating a European Health Data Space.
Enabling innovation and digital transformation
The Commission will seek changes to the regulatory framework governing pharmaceuticals to enable full use of new technologies such as genomics and personalised medicine combining both medicines and medical devices. It will also support collaboration on high performance computing and artificial intelligence. At the same time and importantly, the Commission will ensure the full implementation of the Clinical Trials Regulation which has already been adopted in 2014. Additionally, it will test a framework for the repurposing of off-patent medicines and plans to launch a vaccine platform to monitor the effectiveness and safety of vaccines (PSE, p. 14).
Adapting the regulatory system
Additional changes to the regulatory framework for pharmaceuticals will introduce simplification, streamlined procedures and more flexibility (for example to adapt technical requirements to scientific developments or to enable better lifecycle management of medicines). Other plans contemplate a single assessment procedure across Member States for active substances used for different generic medicines; changed rules for medicines containing genetically modified organisms; expanded powers for regulatory authorities to adapt marketing authoritsations of their own initiative; and modifications of the penalties system for non-compliance with applicable rules (PSE, pages 16 and 17).
3. Enhancing EU resilience and strategic autonomy in crisis preparedness and supply chain security
While the PSE addresses key challenges of patient access, affordability and technology, the central issue presently occupying regulators and legislators is that of medicine supplies and shortages. This explains the Commission’s focus on proposed legislation to impose stronger obligations on marketing authorisation holders with regard to supply; transparency; notification of shortages and withdrawals; and stocks. In the same vein, there will be enhanced EU coordination to monitor, manage and avoid shortages.
Furthermore, the Commission will continue to develop the EU’s “strategic autonomy” in medicines exploring ways to diversify production and supply chains; ensure strategic stockpiling; and foster investment in the European production of critical medicines, pharmaceutical ingredients and active substances (PSE, pages 17 through 19).
Safe and environmentally sustainable medicines
Further changes to the regulatory framework will enhance the environmental sustainability and quality of medicines. This implies a range of measures involving good manufacturing and distribution practices; supervision; audits; international cooperation; and environment-specific measures that cover the entire supply chain (PSE, p. 19).
Health crisis response mechanisms
As the Commission points out, a first important step in this area was the adoption of the European Health Union package (see, Van Bael & Bellis Life Sciences News Alerts of 12 November 2020). The next major proposal is expected next year and will provide for the creation of an EU Health Emergency Response Authority (PSE, p. 21).
4. Creating a strong EU voice on the global stage
The Commission will continue its current approach of working at a global level, backed by the European Medicines Agency and the network of national healh regulators (PSE, p. 22).