On 1^st June 2016 the European Medicines Agency (EMA) released the outcome of the assessment of the first group of applications for its PRIME (PRIority MEdicines) scheme, a new initiative to enhance support for the development of medicines that have the potential to address unmet medical needs.

18 applications for PRIME were received as of 6^th April 2016 and subsequently assessed by EMA. 4 medicines have been accepted for PRIME. EMA is making available detailed information on the applications that have been granted or denied access to PRIME, including statistics on the type of applicants, the therapeutic areas represented and the data supporting the applications. The names of the four active substances that will benefit from PRIME support are also released.

Since 6^th April 2016, another 14 applications have been submitted and, going forward, the Agency will release information on PRIME on a monthly basis, on the Wednesday following the plenary meeting of the CHMP.

EMA launched PRIME (PRIority MEdicines) on 7^th March 2016. The scheme is built on the existing legal and regulatory framework, so as tools already available such as scientific advice, accelerated assessment and conditional approval.

Through PRIME, the Agency offers early dialogue, interaction and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and so to speed up evaluation and availability for the patients of therapies that may significantly improve their quality of life.

Key benefits for applicants are:

• early appointment of Rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy;
• kick-off meeting with the CHMP/CAT Rapporteur and a multidisciplinary group of experts;
• assignment of a dedicated EMA contact point;
• scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment (HTA) bodies;
• confirm potential for accelerated assessment at the time of an application for marketing authorization (in principle, developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorization).

In order to be eligible and accepted for PRIME scheme, a medicine has to show its potential to benefit patients with unmet medical needs, based on early clinical data.

Particular interest is shown for SMEs and academia, which generally have less experience with the regulatory framework and therefore would benefit from earlier scientific and regulatory advice. In fact, while PRIME is open to all companies on the basis of preliminary clinical evidence, applicants from the academic sector and micro-, small- and medium-sized enterprises (SMEs) can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials. They may also request fee waivers for scientific advice.

EMA PRIME scheme comes after the U.S.’s Breakthrough Therapy and Japan’s SAKIGAKE processes also attempting to speed access to new medicines.

By encouraging dialogue with regulators earlier in the development process, PRIME allows for extended consideration of a potential product’s efficacy and safety profile and seeks to address the bottlenecks of the regulatory framework that currently impact medicines development and access.

According to the most recent discussions on PRIME scheme, including EFPIA comments, it seems that one of the key issues to be addressed in order for PRIME to be a success is the involvement of HTA bodies early in PRIME discussions to help avoid delays in reimbursement and pricing decisions after regulatory approval. This is crucial to actually bring new treatments to patients sooner.

The ongoing reform of the EU pharmaceutical legislation is entering a crucial phase. After more than 20 years since the last comprehensive revision, the European Commission’s ambitious proposal aims to create a more agile, competitive, and equitable regulatory framework. In this article, we summarize the key recent updates, the next steps in the legislative process, and highlight some of the most debated aspects from the perspective of the pharmaceutical industry and stakeholders.

Brief Recap: How We Got Here

• April 2023: The European Commission published its long-awaited proposal for a new Regulation (replacing Regulation 726/2004) and Directive (replacing Directive 2001/83/EC).
• The reform focuses on improving access to medicines, strengthening EU competitiveness, tackling supply chain shortages, addressing environmental impact, and streamlining regulatory processes.
• April 2024: The European Parliament adopted its position, advocating for longer data protection periods and additional incentives for innovation.

Latest Updates (as of June 2025)

• June 4, 2025: The Council of the European Union (under the Belgian Presidency) adopted its position:
  • Regulatory Data Protection (RDP): Set at 8 years, with Market Protection (MP) reduced from 2 years to 1 year. MP can be extended by up to 1 additional year if certain conditions are met (e.g., unmet medical need, clinical trials conducted in the EU).
  • Obligation to Supply: Introduces binding obligations for companies to ensure product availability across Member States, with the possibility of penalties for non-compliance.
  • Orphan Medicinal Products (OMPs): Retains 10 years of exclusivity, but introduces a “Global Orphan” system to avoid double protection if products are already marketed elsewhere.
  • Transferable Exclusivity Vouchers (TEVs): Introduced to incentivize the development of new antimicrobials.
  • Bolar Exemption: Expanded to facilitate generic entry, including exemptions for tendering and responsible generics development.
• Interinstitutional negotiations (Trilogues): Officially launched on June 17, 2025, marking the start of final political negotiations. A potential agreement expected in late 2025.

Key Points of Controversy

The reform package has triggered significant debate among industry stakeholders, patient organizations, Member States, and academia:

• Reduced IP Incentives: Many pharmaceutical companies and trade associations (including EFPIA) argue that shorter protection periods could make the EU less attractive for investment in R&D, shifting innovation efforts to markets with stronger IP frameworks such as the US or Asia.
• Obligation to Supply: Industry representatives have voiced concerns about the feasibility and legal implications of mandatory supply obligations, especially for products with limited demand or complex manufacturing chains.
• Environmental Requirements: The introduction of a mandatory “quaternary treatment” to address pharmaceutical residues in wastewater has been criticized as placing disproportionate burdens on the industry compared to other sectors.
• Transferable Vouchers: While intended to stimulate antimicrobial innovation, transferable exclusivity vouchers remain controversial, with doubts about their cost-effectiveness and potential unintended consequences for access and affordability.

Main Differences Compared to Current Legislation

What’s Next? Timeline & Expected Entry into Force

• June 17, 2025: Trilogue negotiations officially started.
• Late 2025: Possible political agreement and adoption.
• 2026: Formal publication of the new Regulation and Directive.
• Entry into force:
  • Regulation: 20 days after publication (immediate applicability).
  • Directive: Transposition period of up to 36 months (~2029 full implementation across Member States).

Implications for the Pharmaceutical Industry

This reform will have far-reaching implications for companies active in regulatory affairs, market access, and pharmaceutical development:

• Companies will need to reassess launch strategies, IP management, and market access planning across the EU.
• The balance between encouraging innovation and accelerating access to generics and biosimilars remains at the center of political debates.
• Increased environmental obligations may lead to significant investments in greener production processes and infrastructure.
• Early engagement with regulators, payers, and national authorities will be key to successfully navigating the new framework.

The EU pharma legislation reform is one of the most comprehensive regulatory overhauls in recent years. As the legislative process moves toward finalization, companies should proactively prepare to adapt to the evolving landscape.

Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through the future European Pharma landscape.