European Commission publishes the Roadmap to the Pharmaceutical Strategy

The publication of this Pharmaceutical Strategy Roadmap confirms the review of the orphan medicinal product and paediatrics regulations, but also announces actions going beyond these two regulations. 

Key points:

• The overall goal of the pharmaceutical strategy initiative is to help ensure EU’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry to remain an innovator and world leader.
• The Commission identified seven main challenges that need to be tackled, namely:

1. A rapidly changing global context which can have a major impact on access to medicines in the EU;
2. Unequal access to medicines that are not always affordable for patients and for national health systems across the EU;
3. Shortage of medicines;
4. Innovation efforts are not always aligned to public health and health systems’ need;
5. Challenges for the EU pharmaceuticals innovation ecosystem;
6. Technological and scientific developments may challenge the regulatory framework and consequently lead to unintended barriers to needs-driven innovation;
7. The way environmental risks are addressed needs to be improved.

• The initiatives taken under the Strategy will aim to meet the following 4 core objectives:

1. Ensure greater access and availability of pharmaceuticals to patients;
2. Ensure affordability of medicines for patients and health systems financial and fiscal sustainability;
3. Enable innovation including for unmet medical needs in harnessing the benefits of digital and emerging science and technology while reducing the environmental footprint;
4. Support EU influence and competitiveness on the global level, reduce direct dependence on manufacturing from non-EU countries, seek a level playing field for EU operators.

• As expected, the pharmaceutical strategy will also examine the need for legislative and non-legislative actions and EU investments. The Legislative actions will build on ongoing initiatives, such as the review of the orphan medicinal product (OMP) and Paediatric Regulations and include a targeted evaluation and subsequent review of the basic pharmaceutical legislation and, if necessary, also other legislative acts.
• EU investments would encompass several programmes, such as Horizon Europe, InvestEU, Digital Europe Programme.

Analysis:

• The Pharmaceutical Strategy forms an integral part of the Commission’s New Industrial Strategy for Europe, published in March this year. The Commission often underlines that the shortcomings in managing the current pandemic has exactly showcased the need for stronger and more assertive EU Industrial and Pharmaceutical strategies. Both aim at contributing to strengthen the global competitiveness of the EU in industrial manufacturing and pharmaceutical value chain. Securing the EU’s ‘strategic autonomy’ in these areas, is becoming the Commission’s new mantra.
• The scope of the Pharmaceutical Strategy is broader than expected as the roadmap underlines the need to better harness technological and scientific developments such as medical technologies, including artificial intelligence (AI). The Commission understands the need to ensure the access and analysis of data collected from clinical experience to support tailored clinical decision-making. There is a clear willingness to review the EU regulatory framework and make it fit to reap the benefits of R&I and new technologies but in a cautious and safely oriented way. 
• The Commission will review the incentives and obligations for innovation, market launch/entry and continuous supply of products as part of ensuring greater access and availability of pharmaceuticals. The review of the OMP and Paediatric Regulations will be part of the Commission’s actions to ensure the right incentives are given to industry, SMEs and other research stakeholders to enable the uptake and market launch of innovative treatments. 
• This Roadmap was published shortly after the Commission decision to propose a standalone Health programme of € 9.37 billion in its proposal for an EU budget for 2021-2027. Such a health programme would be of great support in helping the private sector in reaching some the objectives listed in the Roadmap, including with regards to improving the resilience of health systems and promote the development and access to innovation in healthcare.

Next steps:

• The period for feedback will remain open until 7 July (midnight Brussels time) and enables all interested stakeholders to provide 4000 characters as feedback to the Commission
• The Commission announced it will shortly open an open consultation for a 12-weeks period to collect the feedback of all interested stakeholders.
• The Commission’s final Communication on the Pharmaceutical Strategy is expected to be published in Q4 2020. This communication should provide more information on the legislative and non-legislative initiatives the Commission wants to undertake in the 5 next years.

The roadmap is available at this link