article | 06 Dec 2023

Proposal for new Directive and Regulation on medicinal products for human use

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As previously reported, the European Commission published its proposal for the reform of the EU pharmaceutical legislation on the 26 April 2023. The long-anticipated framework outlines several significant proposals affecting stakeholders in the industry. In this article, Setterwalls’ Nicolas Pershaf and Johan Montan highlight the most-debated proposals in the framework, based on the consultative responses recently submitted by key stakeholders. All of the responses from the consultative bodies can be found here.



Through the introduction of a new Directive and Regulation, the proposal adopted by the Commission amends and replaces the existing legislation on medicinal products for human use, including Regulation 726/2004 and Directive 2001/83/EC, as well as the legislation on orphan and paediatric medicinal products, Regulation 1901/2006 and Regulation 141/2000/EC, respectively.

The proposal, which represents a major reform of the EU framework for medicinal products, aims to ensure that patients have timely and equitable access to medicines, to enhance security of supply and to promote innovation and sustainability. It includes several initiatives to simplify, streamline and modernise the regulatory framework. For example, the period for scientific evaluation of a new application is shortened from 210 days to 180 days from receipt of a valid application. The Regulation also has a provision enabling the Commission to issue temporary emergency marketing authorisations during a public health emergency.

However, other parts of the proposal have been met with critique in several key areas, the most notable of which are presented below.


Regulatory data protection

According to Articles 80 and 81 of the proposed Directive, the minimum period for regulatory data protection for a medicinal product, i.e. the period during which the marketing authorisation holder holds the exclusive rights to the results of preclinical tests and clinical trials, is shortened from eight to six years. The period of time is based on the date on which the marketing authorisation for the medicinal product was granted. Under the proposal, this period may be extended in certain circumstances, allowing an extension of between six months and two years. The marketing authorisation holder may be eligible for one or more of the conditional periods below:

  • An additional two years of data protections is granted if the medicinal product is released in all Member States covered by the marketing authorisation within two years (three years for small- and medium-sized companies);
  • An additional six months of data protections is granted if the marketing authorisation addresses an unmet medical need. An unmet medical need is defined in Article 83 as a medicinal product where at least one of its therapeutic indications relates to a life-threatening or severely debilitating disease, and where certain additional conditions are met;
  • An additional six months of data protection is granted if the medicinal product contains a new active substance[1], provided that the clinical trials supporting the initial market authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the EMA;
  • An additional twelve months of data protection is granted if the marketing authorisation holder obtains authorisation for an additional therapeutic indication.

The change in regulatory data protection represents a major change in the EU pharmaceutical framework, compared to the current eight-year period, which may be extended to eleven years for new therapeutic indications. This may be regarded as a way for the Commission to influence behaviour on the market to promote innovation. However, in its response the Swedish Association of the Pharmaceutical Industry (LIF) states that the various conditions are very difficult to fulfil, and from the company’s and investor’s perspective it will be unpredictable whether they will be able to obtain data protection beyond the basic period of six years, which is of major relevance when making investment decisions. Furthermore, LIF states that the proposal increases the complexity of the already difficult-to-access pharmaceutical regulatory framework, and that the administrative burden will be heavier for both authorities and companies.

On the contrary, some consultative bodies consider that many companies are likely to fulfil the criteria for an extended period of data protection (see for example, the response by the Dental and Pharmaceutical Benefits Agency (Sw. Tandvårds- och läkemedelsförmånsverket, TLV). However, as is pointed out by the Swedish Municipalities and Regions (Sw. Sveriges Kommuner och Regioner, SKR), introduction of a tiered model for data protection such as the one in the proposal creates uncertainty as to when protection periods actually expire and risks obstructing competition and the introduction of generic substitutes.

It should be noted that the Commission’s proposal also provides additional data protection periods for repurposed medicinal products, change in prescription status and for orphan drugs. However, as these changes have not been major points of contention for the consultative bodies they are not covered in this article.


Obligation of appropriate and continueous supply

Article 56 of the proposed Directive states that the marketing authorisation holder for a medicinal product placed on the market in a Member State shall, within the limits of its responsibilities, ensure appropriate and continued supply of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products, to ensure that the needs of the patients in the Member State in question are covered.

While the sentiment of such a provision is understandable, in particular since temporary disruptions in supplies of medicinal products have increased in recent years, several stakeholders have requested clarification as to how the inclusion of wholesale distributors in the obligation applies in the Swedish context. As the Swedish Competition Authority (Sw. Konkurrensverket) states in its response, in Sweden pharmaceutical companies own the medicines until they have been distributed to pharmacies, and there is no scope for wholesalers to buy up stocks of prescription pharmaceuticals. The Swedish Competition Authority therefore considers it crucial that such an obligation to supply does not mean that pharmaceutical companies are obliged to supply wholesalers who intend to trade on markets other than the Swedish market. Such an obligation would pose major difficulties for generic companies, as they would have to be able to meet demand not only on the Swedish market during the month in which their own product is designated as a “product of the period” (Sw. periodens vara), but also demand from wholesalers. According to the Swedish Competition Authority, the product-of-the-period system could be jeopardised if such an obligation to supply is introduced.

In light of the above, several consultative bodies have requested clarification as to whether the proposed article should be interpreted as meaning that the obligation to supply is fulfilled as long as the supplier fulfils supplies to any of the three listed categories, or whether the obligation should be interpreted solely as an option between pharmacies and persons authorised to supply medicinal products. According to the Association of Pharmaceutical Distributors (Sw. Läkemedelsdistributionsföreningen, LDF), this is the single most important issue for Sweden in the proposal, as it could radically change the conditions for the Swedish system of pharmaceutical distribution.


Notification of shortages

The Commission’s proposal also contains provisions regarding a responsibility for the marketing authorisation holder to notify the competent authorities in the event of a permanent cessation of marketing or withdrawal of the authorisation, temporary suspension or temporary disruptions in supply. Under Article 116 of the proposed Regulation:

  • A decision to permanently cease marketing or a withdrawal of the authorisation shall be notified no less than twelve months before the last supply, and
  • A decision to temporarily suspend marketing or a temporary disruption in supply shall be notified no less than six months before such suspension or disruption occurs.

For reference, the requirement (in Sweden) today is that anticipated shortages must be reported no less than two months in advance, at the risk of being sanctioned if the requirement is not fulfilled.

While the timeframes when a company itself chooses to stop, permanently or temporarily, supplying the medicinal products are considered reasonable, several stakeholders have commented on the difficulties in notifying a temporary disruption in supply six months in advance of the disruption.

In its consultative response, the Swedish Association for Generic Medicines (Sw. Föreningen för Generiska Läkemedel, FGL) holds that, for companies that participate in the product-of-the-month system, such an obligation would be impossible to fulfil, since they do not know whether they will provide the product of the month until four weeks before the start of such a period. The overwhelming risk for sanctions due to reporting requirements not being fulfilled is that they may not only cause an “over-reporting” of disruptions in supply, but also increase the risk that pharmaceutical companies withdraw their products from the Swedish market altogether. The Swedish Medical Products Agency (Sw. Läkemedelverket) and LIF share FGL’s doubts about the period for notifying temporary shortages, as companies rarely have the information needed so far in advance.


A more effective regulatory process

For instance, Article 46 of the Directive and Article 17 of the Regulation state that a marketing authorisation for a medicinal product shall be valid for an unlimited period and that a renewal every five years is no longer required. However, the competent authority may in some cases limit the validity of the national marketing authorisation to five years. As the Swedish Medical Products Agency notes, this could lead to a non-harmonised situation in the EU, whereby some Member States would issue authorisations without a time limit, while others do not. Such a situation would send mixed signals regarding the medicinal product’s safety profile and would be impractical, not least from a procedural perspective.


Summary remarks

While the Commission’s proposal contains several welcome changes to the European pharmaceutical regulatory framework, it has been met with critique in some notable respects. Now further discussions are awaited at Union level before the European Parliament votes on the implementation of a final version of the proposal. In view of the many remarks by consultative bodies, the contents of the final Regulation and Directive are likely to differ from the Commission’s current proposal.

Setterwalls looks forward to seeing how this develops and is continuing to monitor the process. As the proposal is extensive, and this article only covers some of the main takeaways and responses from consultative bodies, we are of course happy to assist should you have any questions on the matter.

[1] A new active substance is one that has not already been used in another medicinal product for which marketing authorisation has been granted in the EU/EEA.


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