EU General Pharmaceuticals Legislation Review

EU Pharma Legislation Review Series

Regulatory Data Protection

The Commission's proposal to revise the EU's general pharmaceutical has shaken up the periods of regulatory data exclusivities available for new medicines. The proposal sets out that innovative medicines will have a minimum period of regulatory protection of 8 years (including 6 years of data protection and 2 years of market protection). Medicines may benefit from additional periods of protection if they satisfy certain criteria, which may increase the total period of regulatory protection up to a maximum of 12 years (as compared to the current maximum of 11 years). However, satisfying these criteria may be challenging in practice. We explore these changes further and discuss their pros and cons for medicines manufacturers.

Orphan Medicines

The Commission's proposal to revise the EU's general pharmaceutical legislation introduces major changes in the area of orphan medicines rules. In particular, the proposal significantly reshapes the incentive system and gives new powers to the EMA with regard to orphan designations. We discuss these changes and our takes on the proposals that were introduced in the hope of better identifying rare diseases, expediting the orphan designation procedure and incentivising R&D of orphan medicines addressing high unmet medical need.

Paediatric Medicines

The Commission's proposal to revise the EU's general pharmaceutical legislation introduces several key changes for paediatric medicines, especially for paediatric investigation plans (PIPs). We discuss these changes and our headline observations on the overall theme of more stringent obligations and scrutiny of PIPs, together with the new step-wise PIP system aimed at easing the regulatory burden.

The Regulatory Sandbox – A Safe Space for Innovators to Grow

The Commission has introduced a new concept of "regulatory sandboxes" in its latest proposal to revise the EU's general pharmaceutical. The regulatory sandbox is proposed to be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a “real world environment,” subject to appropriate safeguards. We take a look at how these sandboxes are intended to work under the draft legislation and their potential applicability for new and innovative technologies.

Pharmacy and Hospital Exemptions

The Commission's proposal to revise the EU general pharmaceutical legislation proposes an expansion of the existing pharmacy exemption for magistral formulations, and introduces several changes to the hospital exemption for ATMPs. In this blog, we discuss these changes. While these amendments were introduced to expand the availability of medicines, they may ultimately conflict with the other objective of the revision - to stimulate innovation.

Addressing Environmental Risks

The European Commission plans to refuse marketing authorizations for environmentally unfriendly medicines. Under the Commission's proposals, the European authorities will be able to refuse a marketing authorization application where the accompanying Environmental Risk Assessment (“ERA”) is not adequate, or if the environmental risks have not been sufficiently addressed. The European authorities will also be able to impose environment related conditions of use on authorized medicines, including limiting the product to prescription-only or requiring additional post-authorization ERAs. They will also be able to suspend, revoke or vary marketing authorizations where a medicine presents a serious risk to the environment.

AMR and Transferable Exclusivity Vouchers

The Commission has proposed broad measures to increase the supervision and monitoring of the use of antimicrobial medicinal products, with the aim to counter the spread of antimicrobial resistance. At the same time, the measures are also aimed at promoting and incentivizing the development of new priority antimicrobials through the use of transferable data exclusivity vouchers.

GMO Medicines

The European Commission is streamlining the rules for clinical trials of GMO medicines. Under the Commission's proposals, sponsors will include a detailed environmental risk assessment in a single, centralized application. In turn, the Commission will exempt clinical trials from the scope of many GMO rules. The new system will be leaner, greener and will get potentially life-saving treatments to patients with less administrative delay.

Access to Documents and Transparency of R&D Funding

The Commission's proposals contain some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of R&D activities of medicines. The changes include a new public disclosure obligation that can apply to any financial support from public authorities received for R&D activities for marketed medicinal products. We take a closer look at the proposed changes.

Bolar Exemption under Patent Rights

In its proposal to revise the EU's general pharmaceutical, the Commission has clarified the scope of the Bolar exemption under EU law (which grants an exemption for generic/biosimilar manufacturers to make use of the patent rights underlying an innovative medicinal product when preparing a corresponding generic/biosimilar marketing authorization application). The revised wording for the exemption now expressly encompasses pricing and reimbursement activities for such generic/biosimilar products, and will also apply to third party suppliers and service providers. We take a closer look at these proposed changes.

Supply Security and Shortages Control

The Commission has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages. In particular, there are new obligations for Marketing Authorization Holders and competent authorities are given more power to better monitor and control the availability of medicines on the market.

Marketing Authorisations

The Commission's proposal maintains the current flexibility to seek a marketing authorisation either centrally, purely nationally or through the decentralised or mutual recognition procedures. At the same time, the proposal introduces some significant changes to streamline the EU's regulatory procedures to promote innovation, increase access to medicines and reduce administrative burden.

Advertising Updates Reflect Evolution Rather than Revolution

Medicines advertising and promotion rules are of key interest to pharmaceutical companies operating in the EU. This blog looks into how the new legislative proposal might affect the advertising landscape, in particular for comparative advertising.

Decentralized Manufacturing

The Commission has proposed new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products. In particular, registered decentralized manufacturing sites will operate under the responsibility of a central manufacturing authorization holder, and new obligations will be imposed on manufacturers and on national competent authorities for decentralized sites.

National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure

This blog discusses the Commission's proposed changes to the Mutual Recognition Procedure ("MRP") and Decentralized Procedure ("DCP"). The procedures are broadly aligned with the current rules. However, there are some key changes. These include, the Directive allows Member States to “opt-in” to procedures, it potentially blocks MRP for a year after an initial marketing authorization (“MA”) is granted and it provides for a shorter examination period (now 180 days).

Temporary Emergency Marketing Authorizations

Following the COVID-19 pandemic, the Commission has proposed to introduce of a temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.” The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations. However, it is unclear whether in practice this will be a faster procedure than existing expedited approval routes.

Data Protection Aspects

The Commission's proposals to reform the EU's pharmaceutical regulations includes a number of updates to data protection issues, including a new legal right for the EMA to conduct "regulatory science activities" on any health data it receives without obtaining additional consents. We take a closer look at these proposed changes.


EU law requires marketing authorization holders, national competent authorities, and the European Medicines Agency ("EMA") to operate a pharmacovigilance system, which is key to ensuring that the safety of medicines is monitored during their use.  In its Proposal, the Commission has introduced only limited changes to the existing EU provisions on pharmacovigilance. However, the Proposal does introduce new provisions on risk management for generic and biosimilar products, and provide clarification as to the scope of the obligation to collect and report pharmacovigilance information.

New Classification Mechanism for Borderline Cases

Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product, and consequently, as to what legal rules must be complied with, can have significant consequences for product developers and innovators. In this blog post, we discuss the Commission’s new proposed borderline classification mechanism, which aims at clarifying whether a product could be considered a medicine early on in the development process.

Unitary Supplementary Protection Certificates and Recast

On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (SPCs) throughout the EU, as well as a draft recast of the basic SPC Regulation currently in force. We take a closer look at the proposed changes.

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