EMA Overhauls the Medicine Legislative and Regulatory Framework

On 26 April 2023, the European Medicines Agency (EMA) published two legislative proposals—a new Regulation 2023/0131 and a new Directive 2023/0132 to replace the current European Union (EU) regulatory framework for all medicines (1,2). This legislative proposal will amend the current regulations on advanced therapy medicinal products (ATMPs) (3) and clinical trials (4), while also repealing the regulation that sets out the procedures for authorization and supervision of medicinal products (5), and the regulations for rare disease and medicines for children (6). The new regulation aims to make medicine more widely available, accessible, affordable, and sustainable, and to drive innovation and enable the European pharma industry to compete in the wider arena.

Faster approval times

The proposal aims to reduce the timeframe of the approval procedure from the current average of 400 days, by cutting regulatory review times from 210 days to 180 days for most medicines and 150 days for medicines that are of major interest to public health. It also reduces the time taken for receiving a decision on marketing authorizations (MA) following recommendations from EMA, from 67 days to 46 days.

EMA will also simplify its structure from five to two main scientific assessment committees for human medicines: the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee (PRAC). The current ATMP, orphan, and paediatric committees will be discontinued.

In addition, EMA plans to adopt a “rolling review” system similar to the one that was implemented during the COVID-19 pandemic, which will allow the regulators to examine clinical trial data as they become available, rather than waiting for a single submission once all clinical trials are complete (7).

Potential changes to regulation protection periods

The revised legislation will overhaul the legislative framework and could result in a maximum patent protection of up to 12 years compared to 11 years for non-orphan drugs; however, this will result in market exclusivity being reduced from 10 years (eight years of data exclusivity plus two years of market exclusivity) to eight years (six years of data exclusivity plus two years of market exclusivity). However, new medicines may extend the period of protection by:

• addressing an unmet medical need (an additional six months)
• conducting comparative clinical trials (an additional six months)
• developing a new therapeutic indication (an additional one year)

• launching the new medicine in all EU member states (an additional two years).

Similarly, market exclusivity of orphan drugs could result in a maximum patent protection of up to 13 years compared to the current 10-year span for orphan drugs. The standard market exclusivity period will be reduced from 10 years to nine years; however, orphan medicines may benefit from additional periods of protection, increasing the total period up to a maximum of 13 years, with additional increments being available by:

• launching the new medicine in all EU member states (an additional year)
• addressing a high unmet medical need (an additional one year)
• developing a new therapeutic indication (up to an additional two years) (7).

Thus, the new regulation is likely to reduce the period of regulatory protection granted for innovator companies given that it is extremely challenging to gain approval in addition to pricing and reimbursement (P&R) in all member states—P&R is governed by national law and not in the control of the MA holder.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is concerned that changes in market protection will undermine pharma’s future investment in R&D and the development of innovative medicines (8). Responding to the proposed changes, Nathalie Moll, director general of EFPIA commented, “The approach set out in the pharmaceutical legislation, penalizing innovation if a medicine is not available in all member states within two years, is fundamentally flawed and represents an impossible target for companies. The vast majority of delays in access to new medicines are known to occur after a company has filed for pricing and reimbursement and is awaiting a decision so that the new treatment can be made available to patients” (8).

Contingency planning

In terms of contingency planning, EMA will compile an EU-wide list of critical medicines and will provide recommendations to companies to strengthen the supply chains should the need arise. Under the new proposal, all MA holders will need to put in place a shortage prevention plan for each medicine on the market, any critical shortages would need to be reported to EMA.

The new regulation also provides temporary measures such as emergency MA for crisis-related medicines allowing the EU to take control of drug manufacturing in response to an emergency. This point has raised concerns amongst the pharma industry as compulsory licensing could weaken pharma’s ability to protect its intellectual property (IP). In an interview with the Financial Times, Vas Narasimham, the CEO of Novartis, noted that “compulsory licensing will damage the ecosystem for emergency response” (9).

Incentives to tackle microbial resistance

EMA aims to incentivize the industry to develop novel antimicrobial resistance through the introduction of transferable data-exclusivity vouchers, which would grant an additional year of data exclusivity for any medicine and can be sold to other companies (10,11). The vouchers will be provided in limited numbers over a limited period; a maximum of 10 vouchers over 15 years. Strict rules will apply to their transfer and use.

Other important changes

Under the proposed changes, within 30 days of receiving a MA, pharmaceutical companies will be required to publish information regarding all direct financial support for the R&D of medicines received from public authorities or publicly funded bodies.

MA applicants are already required to include an environmental risk assessment (ERA) of the medicine; however, the EC will strengthen the use of the ERAs to reduce the potential adverse impacts of medicines on the environment and public health. Under the new proposals, medicine approvals may be refused if a company does not provide adequate evidence that environmental risks were evaluated, and risk mitigation measures were taken.

Currently, pharmacies are only allowed to prepare and dispense products in response to individual prescriptions. The legal proposal allows hospital pharmacies greater flexibility to prepare a product for dispensing medicines and clarifies rules on hospital exemptions (12).

Future outlook

The Council of the EU is in discussion with its preparatory bodies and will provide the legislative proposal to the European Parliament and the European Council for their consideration. It remains to be seen how the pharma industry will respond to the new proposal given the intense pressure companies are under to lower drug prices whilst recouping a return on investment. In the meantime, EFPIA is committed to working with members of the European Parliament, the Council of the EU, and other stakeholders “to ensure the revised pharmaceutical legislation and patent package meets the needs of patients, our healthcare systems, member states, and Europe’s life science sector” (8).

No timelines on the adoption of this new regulatory framework are forthcoming, but it is unlikely that the proposed reform will take place before the 2024 EU parliamentary elections.

References

1. EC. Reform of the EU Pharmaceutical Legislation. Health.ec.europa.eu, 26 April 2023.
2. EC. Proposal For a Regulation of the European Parliament and of the Council Laying Down Union Procedures for the Authorization and Supervision of Medicinal Products for Human Use And Establishing Rules Governing The European Medicines Agency, Amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and Repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (26 April 2023).
3. EC. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (26 July 2019).
4. EC. Consolidated Text: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC (16 April 2014).
5. EC. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorization and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency (31 March 2004).
6. EC. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on Medicinal Products for Paediatric use and Amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (12 Dec. 2006).
7. Worden, T; Nauth, L. The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years. Goodwin, Alert, 27 April 2023.
8. EFPIA, EU Pharma-Legislation Risks Sabotaging Europe’s Life Science Industry Putting European Patients Further Away from Cutting-Edge Healthcare. EFPIA.eu, 26 April 2023.
9. Mancini, D.P.; Kuchler H., Novartis Chief Criticizes EU Move to Control Pharma Licensing in Emergencies. Financial Times, 26 April 2023.
10. EC. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Reform of the Pharmaceutical Legislation and Measures Addressing Antimicrobial Resistance (25 April 2023).
11. EC. Proposal for a Council Recommendation on Stepping Up EU Actions to Combat Antimicrobial Resistance in a One Health Approach (12 May 2023).
12. Castle, G.; Bogaert, P.; Doyle-Rossi, M. EU Pharma Legislation Review Series: The EU’s Proposals to Amend its Pharmaceutical Laws Released Today. Inside EU Life Sciences, Covington, 26 April 2023.

About the author

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

Article details

Pharmaceutical Technology Europe
Vol. 35, No. 6
June 2023
Pages: 7–8

Citation

When referring to this article, please cite it as Barton, C. EMA Overhauls the Medicine Legislative and Regulatory Framework. Pharmaceutical Technology Europe, 2023, 35 (6), 7–8.