EU Pharma Package: Regulatory data and market protection

The Commission’s initial draft provided for a significant reduction in both regulatory data protection and regulatory market protection. It was on this point that the differing interests of the stakeholders involved, as well as the proposals from the Commission, Parliament and Council, were most at odds. The breakthrough in the trilogue negotiations in December 2025 on this point was, therefore, a key enabler for the continuation and successful conclusion of the legislative process. 

Currently, a protection period of eight years is provided for regulatory data protection (Art. 14(11) of Regulation (EU) No 726/2004 ["Medicinal Products Regulation"] and Article 10(1) of Directive 2001/83/EC ["Medicinal Products Directive"]). During this protection period, reference to the clinical data (in the dossier) of an authorised medicinal product is not permitted for the purposes of a marketing authorisation application for a generic medicinal product. Such generic marketing authorisation applications are not processed or are rejected within the regulatory data protection period. 

Furthermore, currently the authorised medicinal product is generally granted a ten-year regulatory market protection Article 14(11) of the Medicinal Products Regulation and Article 10(1) of the Medicinal Products Directive), i.e. even though the clinical data of the authorised medicinal product can be referenced in a generic marketing authorisation application, the originator medicinal product enjoys further two years protection against generic competition in the market. Regulatory market protection may be extended by a further year to eleven years if, within the first eight years following the granting of the marketing authorisation, the marketing authorisation holder obtains authorisation for the authorised medicinal product for at least one new indication which, during the scientific assessment prior to its authorisation, is considered to offer significant clinical benefit in comparison with existing therapies. 

However, the protection periods for regulatory data protection and regulatory market protection are always calculated from the date of the first marketing authorisation (so-called initial authorisation) for the active substance in question. Medicinal products containing the same active substance in different strengths, pharmaceutical forms, routes and methods of administration, as well as all changes and extensions, must also be authorised or included in the initial authorisation. However, all such additional or subsequent authorisations form part of the same global (initial) marketing authorisation, particularly for the purposes of applying the regulatory data and marketing protection periods (Article 6(1) of the Medicinal Products Directive). 

Under the Commission’s 2023 proposal, the basic protection period for clinical data was to be reduced to six years. This basic protection period was to be followed by a two-year period of regulatory market protection (i.e. the market protection should last eight years at maximum). The Commission’s proposal thus envisaged a significant reduction of the periods of regulatory data and market protection, which led to considerable resistance from the industry. 

Regulatory basic protection in the EU Pharma Package 

As before, the basic protection period provided for regulatory data protection is eight years from the date of the first (initial) authorisation of the reference medicinal product (Article 80(1) of the Revised Medicinal Products Directive. During this protection period, reference to the clinical data (dossier) of the reference medicinal product for the purposes of applying for a marketing authorisation for a generic, hybrid, biosimilar or biohybrid medicinal product is not permitted. In this regard, Article 80(1), second sentence of the Revised Medicinal Products Directive clarifies that the start of the protection period is to be based on the initial authorisation in the EU in accordance with Article 5(2) of the Revised Medicinal Products Directive. This means that, in accordance with Article 5(2) of the Revised Medicinal Products Directive, following an initial authorisation in the EU, all further developments of the medicinal product covered by the initial authorisation – such as additional therapeutic indications, strengths, pharmaceutical forms, routes of administration and packaging forms – as well as all variations to the initial authorisation, also require authorisation. However, these authorisations continue to be regarded as part of the same global authorisation, in particular for the purposes of the expiry of the regulatory data protection period as well as the regulatory market protection.

Regulatory data protection is then followed by regulatory market protection under the basic protection regime, with a basic protection period of one year (Article 80(2) of the Revised Medicinal Products Directive). This regulatory market protection, which is in principle for one year, means that a medicinal product authorised by reference to a reference medicinal product may not be marketed despite the authorization. In other words, the original medicinal product enjoys basic regulatory protection against generic competition for a total of nine years as basic protection period. 

For the regulatory protection of medicinal products authorised under the Revised Medicinal Products Regulation  (through centralised procedure), Article 29 of the Draft Medicial Products Regulation refers to the protection period regime set out in Chapter VII of the Drat Medicinal Products Directive.

The new, more flexible extension options

The basic regulatory protection outlined above can be extended more flexibly under the Revised Medicinal Products Directive than under the current legal framework (the so-called "8+2(+1)" formula). In the best-case scenario, regulatory protection for the original medicinal product against generic competition may result in a protection period of up to a total of 12 years (the new so-called "8 (+1) +1(+1)(+1)" formula). The extension options largely apply independently of one another.

Extension of regulatory data/document protection through an exclusivity voucher

Firstly, pursuant to Article 41(1) of the Revised Medicinal Products Regulation, an extension of regulatory data protection by one year is possible through the use of an exclusivity voucher granted for the development of a new priority antimicrobial medicinal product. Each exclusivity voucher may be used only once and only for one-time extension of regulatory data protection. These exclusivity vouchers are not only applicable to the extension of regulatory data protection for the authorised priority antimicrobial medicinal product, but may also, pursuant to Article 41(1) of the Revised Medicinal Products Regulation, be used to extend the regulatory data protection of another authorised medicinal product of the same or another marketing authorisation holder. However, a transfer may only be made to a medicinal product authorised under the centralised procedure. Furthermore, the exclusivity voucher may only be transferred in the fifth or sixth year of the regulatory data protection period of the other authorised medicinal product. In addition, the marketing authorisation holder of the other medicinal product must demonstrate that the annual gross turnover of that medicinal product, to which the exclusivity voucher is to be transferred, did not exceed EUR 490 million in the European Union in any of the first four years following the grant of the marketing authorisation. The exclusivity voucher is, therefore, not transferable for the purpose of extending the regulatory data protection of so-called blockbuster medicinal products. 

Extension of regulatory market protection

Regulatory market protection may be extended by a further year in each instance if the requirements of one of the extensions options set out below are met. The extension options apply independently of one another and, where applicable, each results to a one-year extension. It is clarified, however, that regulatory market protection may be extended by a maximum of two years, i.e. to a maximum of three years, but only if the grounds for extension under Article 81(2) and (2a) of the Revised Medicinal Products Directive are combined. If the requirements of several extension options provided in Article 81(2) of the Revised Medicinal Products Directive apply simultaneously, these cannot be combined, meaning that the extension remains limited to one year, i.e. resulting in a regulatory market protection of two years only after expiry of the applicable regulatory data protection period.

For the extension under Article 81(2) of the Revised Medicinal Products Directive, the marketing authorisation holder has several alternative options available to obtain an extension for one further year. 

• In the first alternative (a), the applicant for marketing authorisation must demonstrate, at the time of the initial application, that the medicinal product meets an unmet medical need within the meaning of Article 83 of the Revised Medicinal Products Directive. 
• The three further alternatives (b) to (d) in Article 81(2) of the Revised Medicinal Products Directive are linked to the fact that the medicinal product contains a new active substance. In the first two alternatives (b) and (c) the applicant must demonstrate that the initial application for a medicinal product containing a new active substance is based on a comparative clinical trial conducted with a relevant and evidence-based comparator substance agreed upon following scientific consultation with the European Medicines Agency (EMA). In addition, either the marketing authorisation application must first be submitted to the competent authority in the European Union or was submitted to the competent authority in the European Union no later than 90 days after the submission of the application for the first marketing authorisation outside the European Union (alternative (b)), or the clinical trials relied upon in the marketing authorisation application to assess the efficacy of the medicinal product must be conducted in more than one Member State (alternative (c)). If the applicant can justify that a comparative study required under alternatives (b) and (c) is not possible or inappropriate, this may be replaced under alternative (d) by the applicant demonstrating that the clinical trials relied upon in the marketing authorisation application were conducted in more than one Member State and that the marketing authorisation application was first submitted to the competent authority in the EU or was submitted to the competent authority in the European Union no later than 90 days after the submission of the application for the first marketing authorisation outside the European Union.

Under Article 81(2a) of the Revised Medicinal Products Directive, regulatory market protection may be extended by one year if the medicinal product is authorised for new therapeutic indications during the period of regulatory data protection, provided that this authorisation for the additional therapeutic indication results in significant clinical benefit. The extension under Article 81(2a) of the Revised Medicinal Directive is granted only once for the medicinal product concerned, regardless of the number of additional new therapeutic indications with significant clinical benefit.

Regulatory protection for ‘repurposed’ medicinal products

For so-called ‘repurposed’ medicinal products, Article 84 of the Revised Medicinal Products Directive provides for a separate period of regulatory data protection which is reduced to four years. Covered by this provision are medicinal products based on a known active substance for which a marketing authorisation is granted for a new therapeutic indication the concerned active substance was not previously authorised for in the European Union. The granting of this shortened regulatory data protection is subject to two conditions which must be met cumulatively. Firstly, clinical (and, where necessary, pre-clinical) studies must demonstrate that the medicinal product has a significant clinical benefit in the new therapeutic indication. Secondly, the concerned medicinal product must not have previously enjoyed regulatory data protection, i.e. must be authorised as a generic, hybrid, biosimilar or biohybrid medicinal product, or alternatively, 25 years must have elapsed since the initial authorization of the concerned medicinal product. This four-year regulatory data protection period may be granted only once per medicinal product.

What should be done in light of the revised legal framework?

As before, regulatory protection mechanisms should form part of a comprehensive protection strategy for medicinal products and be closely coordinated with the protection afforded by intellectual property rights. In this context, the more fragmented options for extending regulatory protection periods – which in many cases are already subject to conditions that must be met at the time of the initial marketing authorisation application – present a particular challenge and must be incorporated at an early stage into the planning of a holistic market exclusivity strategy for an originator medicinal product. The exclusivity voucher, which offers the extension of regulatory data protection of a medicinal product, represents an additional tradeable asset for companies specialising in the development of antimicrobial medicines, enabling them to finance their development.