The Pharmaceutical Legislation: A Challenge to Solve Everything

In November 2020, the European Union published the Pharmaceutical Strategy for Europe. One of its key initiatives includes the revision of the EU’s general pharmaceutical legislation and the legislation on medicines for children and rare diseases. The revision, happening for the first time in 20 years, will update the EU general pharmaceuticals legislation.

The new pharmaceutical legislation aims to establish an innovation-focused environment with a strong intellectual property system that supports European industries and promotes regional strategic autonomy. The European Commission has emphasized that the upcoming legislation prioritizes both patient welfare and the competitiveness of the EU industry. Importantly, the process will affect the whole life cycle of medicines, from the way they are developed, authorized, put on the market, and disposed of. The ongoing revision intends to simplify the existing regulatory framework, which consists of Regulation 726/2004, Regulation 141/2000, Regulation 1901/2006, and Directive 2001/83, and compile it into one Regulation and one Directive. Additionally, the package includes Council Conclusions on Antimicrobial Resistance (AMR).

Timeline

Following the publication of the Pharmaceutical Strategy for Europe, the roadmap/inception impact assessment was published on 30 March 2021. The feedback period saw good participation from European stakeholders active in EU health policy. The Commission’s legislative proposal for this revision was initially planned to be adopted in December 2022 but it was finally presented on 26 April 2023. The package had been postponed at least three times, the last one being from 29 March 2023 to 26 April 2023, causing major criticism from different Members of the European Parliament, who eagerly awaited the publication of these proposals to start negotiations as soon as possible. Now that the proposal has been introduced, it is the turn of the European Parliament and the Council to begin negotiations that lead to a compromise text. European’s Parliament Committee on the Environment, Public Health and Food Safety (EP ENVI) is the one to lea the file at the Parliament level. Once the approval of Council and Parliament is achieved, the report is set for vote at the EP Plenary. However, given the length and complexity of the file, it is not expected to be adopted until 2025.

Key topics

In early February, POLITICO had access to a leaked draft of the proposal to a first version of the file, that have been watered down for the final version of the text that was presented. The key measures presented could be summarised in the following points:

1. Orphan medicinal products: the duration is set at 9 years, with exceptions that can grant additional time ranging from 6 months to 1 year which include new medical indications or the simultaneous launch of the medicine in all EU27 Member States.
2. Unmet medical needs: the modulation of regulatory data protection has also been made conditional on unmet medical needs. The baseline protection has been reduced to 6 years and a set of incentives has been proposed to add extra time the current standard period. Examples include an EU27 launch, comparative clinical trials, or new therapeutic indications.
3. Transferable Exclusivity Vouchers (TEV): These vouchers grant one additional year of regulatory data protection for companies which develop new antimicrobials . The number of vouchers is limited in quantity and time, with total of 10 vouchers to be awarded in the 15 years following the approval of the legislation. After such period, the EU will revise the effectiveness of this measure.
4. Temporary Emergency Marketing Authorization (TEMA): in the event of a public health emergency, a possibility to grant a temporary emergency marketing authorization is proposed, given that the benefit of immediate availability outweighs the risk of incomplete clinical data.
5. Regulatory sandboxes: They provide a structured testing environment in which innovative methods and novel medicines can be tried out under the supervision of regulators.
6. Shortage prevention plans: companies have the obligation to notify regulatory authorities of potential shortages in advance and create prevention plans to mitigate the possible interruption of supply.
7. List of critical medicines: The EU, in collaboration with the European Medicines Agency (EMA) and Health Emergency Preparedness and Response Authority (HERA)will establish a list of critical shortages of medicinal products and a list of critical products to enhance preparedness and monitoring.
8. New structure for EMA: the structure of the EMA scientific committees is reduced to two main Committees, the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC).

On 26 April 2023, Commissioner for Health and Food Safety, Stella Kyriakides, held a press conference with Commissioner for Promoting a European Way of Life, Margaritis Schinas to introduce the legislative proposal. She mentioned that the proposal is focused on three A’s: affordability, availability, and accessibility. It brings a set of measures that balance innovation, access, competitiveness, and patient rights.

Relevance for pharmaceutical companies

The proposal includes measures such as modulation of regulatory data protection, TEVs, shortage plans or environmental assessments that affect pharmaceutical companies, from companiess that manufacture generics to those that develop innovative medicines. Commissioner Kyriakides mentioned during the press conference, and in other events after, about the importance of striking a balance between competitiveness and innovation vis-à-vis access to affordable medicines for all patients.

As it usually happens when the Commission launches a proposal, almost no one is happy about it. Associations like European Federation of Pharmaceutical Industry and Associations (EFPIA) or Medicines for Europe, representatives of innovative and biosimilar industry respectively, have voiced their concerns regarding the proposal. Overall, they agree on the fact that regulating and reducing the regulatory data protection is, on one hand, dis-incentivising investment in the European pharmaceutical sector, and on the other hand, not bringing the market entry of generics any closer.

Other concerns include higher requirements in terms of environmental risk assessment and the need to create shortage prevention plans and mitigating measures. While, initially, this should not be a problem, in reality it could pose bigger burdens, specially on small- and medium-sized enterprises (SMEs).

What’s next

In conclusion, the revision of the pharmaceutical legislation in the EU seeks to create a regulatory framework that supports both the industry and the European citizens. However, the challenges surrounding the new proposal were only further sparked by its constant delays. The files are already at Parliament and Council levels and negotiations are likely to start progressing soon. Upcoming negotiations and outreach activities will shape the final outcome of the pharmaceutical legislation, which will try to ensure a fair solution that benefits patients and promote a thriving innovative and competitive environment for the pharmaceutical companies in the region. The legislative proposal is unlikely to become effective before 2025 and, given the interplay of interests of such diverse groups, the final outcome is sure to disappoint some of them regardless of amendments.

This review is happening for the first time in 20 years, whether it is a well-seized or wasted opportunity, time will tell.

Who will be the final winners/losers of the final text?

Will the EU need to adopt other measures before the legislation is finalized by 2025?

Will this mandate of the European Parliament finish negotiations before elections?

Suggested readings:

Naujokaitytė, Goda, “New EU pharma rules still under wraps“, Science Business, 28 March 2023.

Koffel, Jessica, Turtle, Edward, Wright, Elizabeth, “Five potential EU regulatory changes impacting the life sciences industry in 2023”, European Pharmaceutical Review, 7 February 2023

Moll, Nathalie, “Pharmaceutical Legislation: Two things that need to happen now“, EFPIA, 5 April 2023