Overhauling the Human Medicines Directive and Regulation

The current European Union (EU) regulatory system was established in 1995, and the European Medicines Agency (EMA) works with the European Commission (EC) across 27 member states to ensure the efficacy and safety of human and veterinary medicines across Europe and to promote research and innovation in the development of medicines. New medicines are reviewed through either a centralized procedure or by national competent authorities, through a mutual recognition, decentralized, or national procedure, mainly through the Directive 2001/83/EC (1) and Regulation (EC) No. 726/20049 (2). However, over time the EU regulatory framework has become complex and inefficient and is now in need of an overhaul (3).

New EU framework fit-for-purpose

On 25 Nov. 2020, the EC published the Pharmaceutical Strategy for Europe (4) outlining a new regulatory framework based on a set of four pillars, to promote research and technologies (Figure 1). Work is already underway to revise the legislation on rare/orphan disease (5) and paediatrics (6). The Structured Dialogue initiative was launched on 26 Feb. 2021 to address security of medicine supply (7), and further amendments to the Human Medicines Directive and Regulation are anticipated later this year.

Figure 1: Four pillars outlined in the Pharmaceutical Strategy for Europe (4). [FIGURES ARE COURTESY OF THE AUTHOR.]

On 1 March 2021, the EC published its roadmap to revise the general pharmaceutical legislations building on lessons learnt from the COVID-19 pandemic to ensure that the future regulatory framework is fit-for-purpose and crisis-resistant (3). Since the EC published its strategy roadmap, it has conducted a series of consultations and has proposed a series of amendments to:

• ensure access to affordable medicines
• foster innovation, including in areas of unmet medical need
• improve security of supply
• adapt to new scientific and technological developments
• reduce red tape (8).

The Regulatory Scrutiny Board (RSB), an independent body within the EC that undertakes impact assessments and evaluation fitness checks, has reviewed the proposal and drafted a number of negative opinions. These issues will need to be addressed, and the draft report reviewed and resubmitted to the RSB before the proposal can proceed and be accepted by EU policymakers (9). In 2020, the RSB initially rejected the proposal on the legislation on medicines for children and rare disease, but following resubmission, it was accepted (10).

Feedback from the EC regulatory reform was planned for the fourth quarter of 2022 (8), but given the RSB rejection, it is anticipated this feedback will be delayed until 2023 or further, given that European Parliament elections take place in 2024. However, a delay gives the EC more time to review the pharmaceutical landscape and take on board the RSB comments and other organizations such as European Federation of Pharmaceutical Industries and Association (EFPIA), which has been very vocal in this area.

The time to act is now

A report by Charles River Associates (CRA) undertaken on behalf of the EFPIA highlights the lack of competitiveness in Europe which has led to a decline in pharmaceutical R&D investment, clinical trials, and manufacturing output in recent years (11). Another report published by the Centre for Innovation in Regulatory Science (CIRS), highlights that EMA’s timeline for regulatory review lags behind other regulatory agencies (12).

According to EFPIA, the overall goal of the new regulations should be to reinforce expertise-driven assessment and enable a more agile centralized authorization framework by facilitating member states and removing unnecessary, burdensome interfaces between committees and the EC (Figure 2). To achieve this goal, EFPIA has proposed a number of radical changes which include:

• Implementing high-quality assessments by revising the governance framework, to encourage experts from EU member states to contribute, where appropriate
• Establishing an agile system and rethinking outdated committees and working parties’ structure to improve agility and efficiency
• Identifying and resourcing gaps based on current and future workload and implementing forward‑looking strategies regarding funding and resourcing mechanisms for EMA and the Network.

Figure 2: Building blocks for a new regulatory framework.

More haste, less speed

EMA and its member states have been collaborating for more than 27 years and the pharmaceutical regulations have evolved to meet scientific and regulatory demands. Push back from the RSB has given the EC time to reflect on its reform package and make sure the new regulatory framework is fit-for-purpose and meets the goals laid out in the Pharmaceutical Strategy for Europe and roadmap. It also enables the EC to take into account the lessons learnt from the COVID-19 pandemic, environmental challenges, and to reassess new opportunities presented by the digitalization of healthcare data. More haste and less speed may be necessary to ensure that the EU and its member states are in a strong position to compete in the global arena and attract future investment so it can deliver safer, better medicines to patients, faster.

References

1. EC, Directive 2001/83/EC available from ec.europa.eu [Accessed 10 Nov. 2022].
2. EC, Regulation (EC) No 726/2004 available from ec.europa.eu [Accessed 10 Nov. 2022].
3. EFPIA, “EU Regulatory Network—New Architecture for a New Era,” Guest Blog, efpia.eu 28 April 2022.
4. EC, A Pharmaceutical Strategy for Europe, Communication Document, ec.europa.eu 25 Nov. 2020.
5. EC, Orphan Medicinal Products available from ec.europa.eu [Accessed 10 Nov. 2022].
6. EC, Medicines for Children available from ec.europa.eu [Accessed 10 Nov. 2022]
7. EC, Structured Dialogue on Security of Medicines Supply available from ec.europa.eu [Accessed 10 Nov. 2022].
8. EC, Revision of the EU General Pharmaceuticals Legislation available from ec.europa.eu [Accessed 10 Nov. 2022].
9. Pinsent Masons, “EU Pharma Law Reforms Face Delay,” Out-Law News, 31 Aug. 2022.
10. RSB, Regulatory Scrutiny Board Annual Report 2020, Report, ec.europa.eu 25 May 2021.
11. CRA on behalf of EFPIA, Factors Affecting the Location of Biopharmaceutical Investments and Implications for European Policy Priorities Final Report, Report, efpia.eu, 3 Oct. 2022.
12. CIRS, New Drug Approvals in Six Major Authorities 2011–2020: Focus on Facilitated Regulatory Pathways and Worksharing, Report, cirsci.org, 25 June 2021.

About the author

Cheryl Barton is director of PharmaVision, info@pharmavision.co.uk

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 12
December 2022
Pages: 8–9

Citation

When referring to this article, please cite it as C. Barton, “Overhauling the Human Medicines Directive and Regulation,” Pharmaceutical Technology Europe 34 (12) 2022.