Advertising, marketing authorisation applications and imports are among the areas targeted by the draft proposals.
Nearly three years ago, the European Commission presented a new pharmaceutical strategy for Europe outlining priorities for a future-proof and patient-centred environment in which the EU industry can innovate further and continue to be a global leader in the field. As part of this strategy, a legislative reform was proposed on 26 April 2023.
The draft proposals would repeal and replace Directive 2001/83/EC, Regulation (EC) No 726/2004, and amend the current rules on medicinal products for paediatric use and orphan drugs.
New objectives
"Ex-post evaluations" of existing European legislation showed that patients' needs are not always sufficiently met, whereas affordability of medicinal products remains a challenge for health systems. Reports commissioned by the EU suggest patients have unequal access to medicinal products across Member States, while shortages of medicinal products are an increasing problem, on the back of a regulatory system that does not sufficiently cater for innovation and, in some instances, creates unnecessary administrative burden. In addition, the Commission has acknowledged that the drug lifecycle can have a negative impact on the environment.
The goal of the reform is to ensure that patients across the EU have timely and equitable access to medicines, to enhance security of supply and address shortages through specific measures, to simplify the regulatory pharmaceutical framework and to adapt it to recent scientific, technological and environmental changes. The proposed measures are intended to pursue these objectives.
Innovation and incentives
The legislative reform look to promote innovation and competitiveness through a simplified regulatory framework. The European Medicines Agency (EMA) is set to provide better early regulatory and scientific support for developers of promising medicines to facilitate the fast approval. Scientific evaluation and authorisation of medicines are meant to be sped up. Regulatory burdens would be reduced through simplified procedures and digitisation.
The reform introduces incentives in respect of regulatory data protection and rewards for innovation in areas of unmet medical needs. It attempts to move away from a "one size fits all" system of incentives for pharmaceutical companies. It promotes a modulated system that rewards businesses that fulfil important public health objectives. As far as regulatory data protection is concerned, this means that the period of protection can be extended if certain conditions are met; for example, the medicinal product addresses an unmet medical need).
Better access is also proposed to innovative and affordable medicines for patients and national health systems. Companies are encouraged to make their medicines available to patients in all EU countries. Furthermore, earlier availability of generic and biosimilar medicines are facilitated and market authorisation procedures simplified in the draft proposals. Measures for greater transparency of public funding of medicines development are to be introduced and the generation of comparative clinical data incentivised.
Environmental impact and supply
The environmental impact of medicinal products is also addressed. To limit the potentially negative consequences of medicines on the environment and public health, the reform offers greater enforcement of environmental requirements. Proposed measures include introducing a refusal ground for marketing authorisations when companies do not provide adequate evidence for the evaluation of the environmental risks or proposed risk mitigation measures are not sufficient to address identified risks.
It also addresses shortages of medicines and ensuring security of supply. Upgraded requirements for monitoring of shortages of medicines by national authorities and the EMA are to be introduced. There is also a stronger coordination role for EMA and its committees.
Obligations imposed upon pharmaceutical businesses will be strengthened, including earlier reporting of shortages and withdrawals of medicines, with shortage prevention plans. An EU-wide list of critical medicinal products will be established, and supply-chain vulnerabilities of these medicines will be assessed, with specific recommendations on measures to be taken by supply chain stakeholders.
Advertising tweaks
While the main advertising rules set out under Directive 2001/83/EC remain unchanged, some minor tweaks in the proposed text are worth noting as they will have a bearing for pharmaceutical companies active in the EU.
Directive 2001/83/EC currently states that advertising includes in particular advertising of medicinal products to persons qualified to prescribe or supply them. The proposal adds persons qualified to administer medicinal products to the list of providers concerned by the regulations on advertising to healthcare professionals.
Individuals entitled to deliver medicines are not mentioned in all new provisions; for example, they are excluded from compliance rules, such as anti-gift principles. The ban placed on supplying, offering or promising gifts, pecuniary advantages or benefits in kind (and on soliciting or accepting them) solely applies in respect of persons qualified to prescribe or supply medicines, per the current language of Directive 2001/83/EC.
Supposedly building on recent European case law, the proposal now also covers "advertising related to medicinal products which does not refer to specific medicinal products". In the Euroaptieka SIA case (C‑530/20), the Court of Justice of the European Union (CJEU) ruled that dissemination of information that encourages the purchase of medicinal products may fall within the concept of "advertising", even when that information does not refer to a specific medicinal product, but to unspecified medicinal products. The wording of the proposal is, however, much broader than the language of the CJEU ruling in Euroaptieka SIA, which – if passed into law – is likely to create challenges for foreign and local businesses advertising medicines in the Union.
As regards comparative advertising, a number of clarifications have been introduced by the proposal. For example, any form of advertising that aims to highlight negatively another medicinal product should be prohibited, whereas advertising that suggests that a medicinal product is safer or more effective than another medicinal product should also be prohibited, unless demonstrated and supported by the summary of product characteristics.
The conditions in which samples may be supplied to healthcare professionals have been aligned with the CJEU ruling in the ratiopharm GmbH case (C-786/18). The proposal states that, on an exceptional basis, free samples of medicinal products not subject to medical prescription may also be provided to persons qualified to supply them (for example, pharmacists).
The proposal specifies that the scientific service in charge of information about medicinal products, which must be put in place by marketing authorisation (MA) holders, may be established within their undertaking "or not-for-profit entities", which raises potential questions as to delegation of promotional approvals to such non-profit entities.
Manufacturing and import authorisation
Member States must keep taking appropriate measures to ensure the manufacture of the medicinal products and their import within their territory is subject to a manufacturing and importation authorisation (MIA). Applicants must submit MIA applications by electronic means, which is a new requirement at EU level.
Once the MIA is granted, regulatory obligations applicable to MIA holders are in essence comparable to what is required under Directive 2001/83/EC. Furthermore, if the substance imported, manufactured or distributed is an active substance, registration of activities with the relevant national competent authority remains a legal requirement.
Specifics apply where a MA holder conducts MIA activities in a "decentralised site", including as regards registration and listing. Notably, while decentralised sites do not require a separate MIA from the one granted to the relevant central site, they should be registered by the national competent authority of the Member State in which the decentralised site is established.
Principles of good manufacturing practices (GMP) and good distribution practices (GDP) have to be respected in connection with both medicines and active substances as is the case under the current regime.
The proposal refers to requirements of Directive 91/356/EEC laying down the principles and guidelines of GMP for medicinal products for human use and to the principles and guidelines on GMP, published by the Commission in EudraLex (volume 4). It further enables the Commission to adopt implementing acts supplementing the proposal provisions by specifying principles of GMP and GDP for medicines and active substances.
Marketing authorisation applications
Current procedures for introducing a medicine into the Union market are partly simplified by the proposal, and the scientific evaluation and authorisation of medicines at EU and national levels are intended to be sped up.
All MA procedures are affected. The EU procedure, which is a centralised MA and currently regulated by Regulation (EC) 726/2004, leads to authorisation in all EU and European Economic Area Member States granted by the Commission. Under the proposal, the Commission is set to have 46 days instead of 67 days between the opinion of the Committee for Medicinal Products for Human Use and the final decision on the application for a MA.
The national MA procedure, which is currently regulated by Directive 2001/83/EC, leads to authorisation in one country at a time. The proposal provides that competent Member State authorities are expected to have 180 days instead of 210 to assess local MA applications.
Osborne Clarke comment
The Commission's initiative is a great step towards implementing Europe's Pharmaceutical strategy and its main objectives, including access, availability and safety of medicines and environmental protection.
The proposal has been open for feedback from 26 April.
The feedback period is currently set to end in late October 2023 but will likely be extended further until the proposal is available in all EU languages. It allows contributors to raise comments on the new legislation, which is set to impact a variety of matters ranging from medicinal products' advertising to manufacturing and import authorisation, and marketing authorisation applications.
The next Insight in this "deep dive" series on the EU's proposed reform of the pharmaceutical sector will focus on medical devices and combinations, medicinal products' information and pharmacovigilance.
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