At the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). As we discussed in a previous blog, the new Strategy seeks to introduce new policies and ideas, whilst bringing into the spotlight long standing challenges which were exacerbated by the Covid-19 pandemic. The new Strategy puts forward numerous proposals for legislative reforms that are likely to affect the regulation of the entire life cycle of a medicinal product and the regulation of medical devices. As a reminder, the key elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply of medicinal products.
In this post, we focus on the developments in the first half of 2021, including a pilot project launched by the European Medicines Agency (EMA) on market access and the Commission’s Roadmap on revisions to the pharmaceutical legislation.
Pilot Project on Market Launch of Centrally Authorised Medicinal Products
The new Strategy emphasised the importance of access to medicines. As a first step, in March this year, the European Commission, jointly with the EMA and EU countries, launched a pilot project with the objectives of:
- better understanding the root causes of deferred market launches; and
- improving the EMA’s knowledge of planned marketing of centrally authorised medicinal products and the reasons behind delayed launches.
The pilot invites applicants for marketing authorisations for orphan medicines and cancer therapies to share, on a voluntary and confidential basis, their market launch intentions. The pilot will run until August 2022, and applicants are also offered the opportunity to make suggestions to address and improve any gaps identified. Participation is voluntary and any information supplied will remain confidential and be used solely for the pilot, although the information collected will be published in aggregated form.
The intention is for the EMA to use this research to map out the variations in access to medicines across the EU, and identify the reasons for such variations. This, it would seem, is the first step before proposing policy-based legislative solutions to improving patients’ access to medicines.
The Commission’s Combined Evaluation Roadmap
In line with the new Strategy, in March 2021, the Commission launched the “Combined Evaluation Roadmap/Inception Impact Assessment” to evaluate whether the general pharmaceutical legislation – Directive 2001/83/EC and Regulation (EC) 726/2004 – has delivered its initial objectives. Feedback on the Roadmap was requested through April, and the Commission plans to launch a public consultation for citizens and stakeholders in the second half of 2021. The ultimate likely goal is for the Commission to propose legislative changes in order to strengthen the regulatory system against future crises, with current plans indicating a timeline of Q4 2022.
The proposed amendments to the legislative regime will seek to address perceived weaknesses that come to light during the evaluation phase. The issues identified thus far include:
- unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines;
- varying and unequal access to affordable medicines across the EU;
- current legislation being ill-equipped to deal with and respond effectively to innovative and emerging technologies, such as genomic sequencing, genome editing, artificial intelligence and products based on genetically modified organisms;
- a need for the simplification of applicable rules and procedures, digitisation of tools, and optimisation of interfaces with other frameworks (e.g. medical devices); and
- vulnerability in supply chains, ensuring a greater security of supply and identifying shortages early.
The Commission is considering a number of different options to address these issues. While it is possible that there will be no changes to the current regulations, it is acknowledged that addressing these issues and achieving the overarching objectives of the new Strategy would prove challenging within the existing legislative framework. Therefore, it is likely that revisions will need to be introduced to simplify, amend and future-proof existing legislation.
Stakeholder comments on the Roadmap are available to the public. In particular, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has stated that legislation alone is not the solution to addressing issues around access to medicines or affordability, especially as many of the solutions fall within national competencies. Further, EFPIA observed that the legislative framework must be robust and flexible enough to adapt to innovations in technology, encourage novel clinical trial design, and enhance transparency of supply chains.
Security of medicines supply
Covid-19 has demonstrated that shortages of medicines compromise patient health, and current systems have a limited ability to manage these issues. In our previous blog, we considered the Commission’s proposals to address these issues. In addition, on 26 February 2021, the European Commission launched a “structured dialogue initiative” to seek to strengthen the resilience of pharmaceutical supply chains and ensure the security of supply of medicines. The aim of the dialogue is to put forward, by the end of 2021, a set of policy recommendations to address identified vulnerabilities in the pharmaceutical manufacturing supply chain.
Supply chain issues are also one of the main concerns identified in the Roadmap. It acknowledges that the current provisions need to be enhanced to increase transparency of stock, ensure early notification of anticipated shortages and strengthen the obligation to supply. To this end, the Roadmap proposes potential solutions including placing greater responsibility on actors and increasing oversight of the supply chain.