EU General Pharmaceuticals Legislation Review

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.