The EU commission has launched an initiative on the evaluation and revision of the general pharmaceutical legislation.
In November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe, with the intention of making the European pharmaceutical system patient-centred, future-proof and crisis-resistant. The EU pharmaceuticals system should ensure the quality and safety of medicines, while boosting the sector’s global competitiveness and creating a regulatory environment, which is attractive for innovation and investment and supported by international harmonised standards and regulatory convergence wherever possible. As such, the strategy is a key pillar of the Commission’s vision to build a stronger European Health Union.
About this initiative
This initiative is one part of the implementation of the Pharmaceutical Strategy for Europe. The steps of the initiative are:
- Publishing of a roadmap and seeking feedback between March and April 2021
- A public consultation in Q4 2021
- Commission adoption in Q4 2022 in the form of a regulation
Evaluation of the current legislation
The Commission is evaluating the current general pharmaceutical legislation, namely Directive 2001/83/EC and Regulation (EC) No 726/2004 to assess how they have delivered against their initial objectives.
The evaluation will cover the period from 2005 to the present (date covering the last fundamental amendments to the Directive and Regulation). The geographical scope will be the EU Member States.
The evaluation will focus only on those provisions that relate to the objectives of the Pharmaceutical Strategy for Europe as presented in the roadmap. The preliminary results of the evaluation will be used to establish the baseline situation for the impact assessment, refine the problem definition and the policy options and feed into their analysis.
What are the objectives of this initiative?
As detailed in the roadmap document, this initiative is driven by the following objectives:
- Ensure access to affordable medicines for patients, and address unmet medical needs;
- Enable innovation for the development of high quality, safe, effective medicines, harnessing the benefits of digital and emerging science and technology while reducing the environmental footprint
- Enhance the security of supply of medicines and address shortages;
- Reduce regulatory burden and provide a flexible regulatory framework.
How will the objectives of the initiative be achieved?
To achieve these objectives, 14 elements are listed in the combined roadmap/impact assessment document and include the following:
- Reaching common understanding (either criteria based or definition based) on the notion of ‘unmet medical needs’ building on the relevant discussion taking place in the field of medicines for children and rare diseases and discussions with public authorities responsible for health technology assessment, pricing and reimbursement
- Simplifying legislation and create regulatory attractiveness with the aim to reduce, where possible, regulatory approval times and regulatory costs while keeping the high standards of robust assessment of quality, safety and efficacy.
- Consider providing regulatory authorities the possibility to adapt on their own initiative the terms of marketing authorisations on the basis of scientific evidence
- Possible measures will seek to leverage digital technology and the use of electronic product information
- Revise the system of incentives aiming to ensure options that attract and promote innovation, especially in areas of highest medical need, and establish a tailored system of incentives that links rewards with possible obligations, including the placing on the market of the products in most/all Member States, or more transparency on R&D costs.
- Explore novel incentives that complement or replace or adjust the market protection (or a combination thereof) taking into account the relationship with intellectual property rights
Feedback on the initiative roadmap
The commission is inviting feedback on the roadmap. The feedback period is 30 March 2021 – 27 April 2021.
You can download the roadmap/impact assessment document and find out more about giving feedback, here.
Source: Europa website