Major Review Of EU Pharmaceutical Legislation Kicks Off
Executive Summary
The European Commission has launched the process for reshaping and addressing the long-standing weakness in the EU’s pharmaceutical legislation. It has listed in a roadmap the issues it wants to address as it considers policy options for reforms.
The European Commission has formally kick started its much-publicized plan to revise the EU’s long standing pharmaceutical legislation and deliver the ambitious changes outlined in the pharmaceutical strategy it adopted last November.
As a first step, the commission has published for consultation a “combined evaluation roadmap/inception impact assessment” for the evaluation and revision of the pharmaceutical legislation, which comprises Directive 2001/83/EC and Regulation (EC) No 726/2004. The combined document describes the problems to be tackled, the objectives to be met and the possible impacts of available solutions.
The document was published on 30 March for a four-week consultation period. Feedback is being sought on a range of issues to help the commission evaluate the extent to which the directive and regulation have delivered against their initial objectives.
The commission wants to know, for example, the extent to which existing measures can effectively address the problems identified in the pharmaceutical strategy. Also, it wants to assess the suitability of existing mechanisms for the continuous and timely adaptation of technical requirements in light of emerging science and technologies.
The evaluation will cover the period from 2005 to the present. It will not include all the provisions of the legislation but will “focus on those that relate to the objectives of the Pharmaceutical Strategy,” the commission clarified.
Among other things, the strategy aims to address “potential inefficiencies and administrative burden of regulatory procedures” in the current legislation. The commission noted that there could be room for the “simplification and streamlining of procedures and internal processes to reduce timelines and regulatory burden.” (Also see "EU Regulator Raises Possibility Of Shorter Drug Approval Timelines" - Pink Sheet, 26 Mar, 2021.)
The strategy is designed to reinforce the EU pharmaceutical system’s patient-centered focus and make it future-proof and crisis-resistant. It will also take into account learnings from the COVID-19 pandemic, which has highlighted the importance of ensuring timely access to safe, high quality and affordable medicines, the commission said. (Also see "Radical Shake-Up In Store For Entire EU Pharma Legislation" - Pink Sheet, 25 Nov, 2020.)
To address the weaknesses identified in the current legislation and to implement the objectives of the pharmaceutical strategy, the commission intends to develop policy options that would cover elements such as:
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- Reaching a common understanding (either criteria-based or through a common definition) of the notion of “unmet medical needs.”
- Simplifying legislation and reducing, where possible, regulatory approval times and costs. For this, the commission said, it would consider allowing member states more flexibility in adapting the terms of marketing authorizations in some cases.
- Revising the current system of incentives to promote innovation and establish a tailored system of incentives that links rewards with possible obligations, such as a requirement to place products on the market in most or all EU member states or introducing more transparency on research and development costs.
- Considering specific incentives to promote the development of new classes of antimicrobials.
- Examining ways to increase support and accelerate product development and authorization in areas of unmet need.
- Introducing elements of flexibility that allow future proofing of the legislation by making it adaptable to new innovative ways medicines are developed and evidence is generated.
- Improving the provisions relating to generic/biosimilar competition.
- Providing for a single assessment process across the EU member states for active substances used in different generic medicines (active substance master files) to facilitate their authorization and life-cycle management.
- Enhancing medicines supply, manufacturing and quality, and environmental sustainability. (Also see "EU Launches ‘Structured Dialog’ To Thrash Out Supply Chain Concerns" - Pink Sheet, 1 Mar, 2021.)
The policy options will be developed on the basis of the commission’s evaluation of the current pharmaceutical legislation. It is therefore urging all stakeholders to respond to the evaluation roadmap and inception impact assessment, on which comments will be accepted until 27 April.
Stella Kyriakides, EU commissioner for health and food safety, said the pharmaceutical strategy was the cornerstone of a stronger European Health Union. (Also see "EU Health Ministers To Deliberate Over Commission’s Pharma Strategy" - Pink Sheet, 1 Dec, 2020.)
“To ensure that all patients have access to safe, high quality and affordable medicines, we need a pharmaceutical legislation that is fit for today's world. This is the chance for everyone, citizens and stakeholders alike, to take part in this ambitious reform and help us reshape and strengthen our legislation,” Kyriakides said.
The commission intends to hold another public consultation on the topic in the fourth quarter of 2021. It then plans to issue a legislative proposal for the revision of the general pharmaceutical legislation by the end of 2022.
The revision of the legislation is complementary to other ongoing initiatives in this context, such as the European Health Data Space, which aims to provide high-quality health care while making the most of digital health, and the work on the EU Health Emergency Preparedness and Response Authority.