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Getting ready for the EU Pharma Package: key changes to regulatory exclusivities, orphan medicinal products and the “Bolar” exemption provisions

Getting ready for the EU Pharma Package: key changes to regulatory exclusivities, orphan medicinal products and the “Bolar” exemption provisions

From our blog

A&O Shearman on life sciences
Published Date
Mar 12 2026
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Image of Eda Zhuleku
Eda ZhulekuCounsel, Munich
Image of Florian Preinfalk
Florian PreinfalkAssociate, Munich
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Michaela LindnerAssociate, Munich
After the Council and the European Parliament have reached an agreement in the trilogue negotiations on the so-called Pharma Package in December 2025, the texts of the provisional agreement (comprising a new regulation and a new directive) have now been published. In this first article of a series on the EU Pharma Package, we will have a deep dive on the topics of regulatory exclusivities, orphan medicinal products, and the revised “Bolar” exemption, and assess how the industry can prepare for the upcoming changes.

1. Regulatory exclusivity

Which baseline regulatory exclusivity periods apply?

There will be a baseline period of eight years of regulatory data protection (Article 80(1) of the new directive), followed by a one-year period of regulatory market protection (Article 80(2) of the new directive). 

For so-called “re-purposed” medicinal products, i.e. medicinal products based on a known active substance that are granted a marketing authorization for a new therapeutic indication not previously authorized in the EU for that active substance(s), a regulatory data protection period of four years applies under the following conditions (Article 84 of the new directive):

  1. The medicinal product has not previously benefitted from regulatory data protection or 25 years since the initial marketing authorization have passed.
  2. Clinical (and non-clinical) studies demonstrate a significant clinical benefit in the new therapeutic indication.

This four-year regulatory data protection period can only be granted once per medicinal product.

How can regulatory exclusivity periods be extended?

Regulatory exclusivity periods can be extended more flexibly than under the current “8+2(+1)” formula, leading to a new “8 (+1) +1(+1)(+1)” formula:

One year of additional regulatory market protection may be granted under each of the two following mechanisms, which apply independently:

  • New therapeutic indication—if the medicinal product is authorized for a new therapeutic indication during the regulatory data protection period, provided that it brings a significant clinical benefit (Article 81(2a) of the new directive). This extension can only be granted once, irrespective of the number of additional new therapeutic indications.
  • Development and launch-related criteria—if one of the following scenarios applies (Article 81(2) of the new directive):
    • The medicinal product addresses an unmet medical need at the time of the initial marketing authorization application.
    • Comparative clinical trials have been conducted, and the marketing authorization application has been submitted in the EU no later than 90 days after the first marketing authorization application outside the EU.
    • Comparative clinical trials have been conducted, and clinical trials have been conducted in more than one EU member state.
    • Where comparative clinical trials are not possible or appropriate, clinical trials have been conducted in more than one EU member state, and the marketing authorization application has been submitted in the EU no later than 90 days after the first marketing authorization application outside the EU.
  • Such extension can only be granted once per medicinal product, even if several of the above scenarios are fulfilled. 

One year of additional regulatory data protection can be obtained through an exclusivity voucher granted for a "priority antimicrobial” (Article 41(1) of the new regulation).

Overall, the new framework sets a maximum period of nine years of regulatory data protection (in case the exclusivity voucher is used) and three years of regulatory market protection.  

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How does the transferable exclusivity voucher work?

To support one of the main aims of the Pharma Package, namely combating antimicrobial resistance, a transferable exclusivity voucher is introduced as an incentive for the development of new priority antimicrobials. 

A priority antimicrobial is defined as an antimicrobial that addresses a multi-drug-resistant organism with a significant clinical benefit regarding antimicrobial resistance and either (i) has a new mechanism of action or (ii) contains a new active substance that addresses a serious or life-threatening infection (Article 40(3) of the new regulation).

Furthermore, the applicant inter alia has to demonstrate its capacity to supply sufficient quantities of the priority antimicrobial in the EU and demonstrate that the marketing authorization application has been submitted in the EU no later than 180 days after the first marketing authorization application outside the EU (Article 40(4) of the new regulation).

Once granted:

  • The voucher gives the right to one additional year of regulatory data protection for any medicinal product with a Union marketing authorization. This can be the priority antimicrobial or another medicinal product. However, its use is restricted so that the voucher cannot be used for products with annual gross sales in the EU of more than EUR490 million in the preceding four years (Article 41(1) of the new regulation).
  • The voucher can only be used in the fifth or sixth year of the regulatory data protection period of the receiving product and only if the marketing authorization for the priority antimicrobial for which the voucher was initially granted has not been withdrawn (Article 41(1a) of the new regulation). 
  • The voucher can also be transferred once to another marketing authorization holder (Article 41(3) of the new regulation).
  • The voucher is valid for five years from the date it was granted (Article 42(1) of the new regulation).

The provisions regarding the transferable exclusivity voucher are currently only applicable for the first 15 years after the entry into force of the new regulation or until five vouchers have been issued, whichever occurs first (Article 43 of the new regulation). 

How can the industry prepare?

The more fragmented and conditional regulatory exclusivity periods require early planning and a holistic exclusivity strategy to obtain maximum regulatory protection. In particular, extension options such as conducting comparative clinical trials, conducting EU clinical trials or early launches in the EU as well as future indication expansions need to be considered, also taking into account the duration and expected robustness of patent protection. 

In addition, regulatory exclusivity planning should be more closely integrated with broader IP, market access and commercial strategies in order to avoid protection gaps and ensure coherent lifecycle management. Early, portfolio level assessments can help identify those products for which additional regulatory exclusivity is realistically achievable and commercially meaningful.
Companies developing antimicrobials should consider obtaining an exclusivity voucher, which may represent a significant commercial value.

2. Orphan medicinal products

How is an orphan designation granted?

A medicinal product can be granted an orphan designation if it is:

  1. intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition
  2. the condition affects no more than five in 10,000 persons in the EU
  3. there is no satisfactory treatment method authorized in the EU or the medicinal product would provide a significant benefit (Article 63 of the new regulation).

The European Commission is entitled to further specify these requirements by implementing acts.

Under the current Orphan Regulation (EC) No 141/2000, decisions on the orphan status of a medicinal product are taken by the European Commission based on an opinion by the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA). Under the new regulation, the EMA itself will grant orphan designations within 90 days of the receipt of a valid application (Article 64 of the new regulation).

The orphan designation will only be valid for seven years, which can however be extended in case of ongoing, promising clinical studies (Article 66 of the new regulation). Orphan designations can be transferred to another orphan medicinal product sponsor subject to prior approval of the EMA (Article 65 of the new regulation).

What exclusivity periods apply for orphan medicinal products?

The key regulatory incentive for the research and development of orphan medicinal products, the orphan market exclusivity, is substantially modified under the new regulation. Currently, an indication-specific orphan market exclusivity is granted for ten years, during which marketing authorization applications may not even be accepted and marketing authorizations may not be granted for similar medicinal products in the same therapeutic indication (Article 8(1) of regulation (EC) No 141/2000). 

Under the new regulatory framework, a more differentiated approach will take place (Article 70 of the new regulation):

  • Eleven years orphan market exclusivity for breakthrough orphan medicinal products—these are orphan medicinal products for an indication, for which no authorized product exists, and which bring a clinically relevant reduction in disease morbidity or mortality (Article 70 of the new regulation)
  • Four years orphan market exclusivity for orphan medicinal products authorized based on bibliographical data
  • Nine years orphan market exclusivity for all other orphan medicinal products

Other than today, this orphan market regulation). This means that later orphan marketing authorizations for other indications for the same medicinal product do not trigger new orphan market exclusivity periods. The orphan market exclusivity is, however, prolonged by one additional year if the orphan marketing authorization holder obtains a marketing authorization for a new orphan indication at least two years before the end of the exclusivity period. This prolongation can be granted twice, allowing for a maximum extension of two years (Article 72(2) of the new regulation). The prolongation option does not apply for orphan medicinal products authorized based on bibliographical data.

The impact of the orphan market exclusivity is further reduced by the fact that the new regulation allows the submission, validation and assessment of marketing authorization applications for similar medicinal products during the last two years before the orphan market exclusivity expires (Article 71(6) of the new regulation). Accordingly, generic or biosimilar products could be on the market immediately upon expiry of the orphan market exclusivity, and thus much earlier than today.

On the other hand, the current possibility to review the eligibility criteria for orphan market exclusivity six years after the marketing authorization has been abolished, increasing predictability for orphan marketing authorization holders.

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How can the industry prepare?

The new regulatory framework for orphan medicinal products will in general lead to a lower level of regulatory protection for orphan marketing authorization holders. In particular, the concept of a global orphan marketing authorization with one single orphan market exclusivity period significantly limits the maximum duration of orphan market exclusivity. Orphan marketing authorization holders should therefore be prepared for earlier generic/biosimilar market entries. The timing and sequencing of indication development should be carefully managed, given that additional orphan indications will no longer trigger new exclusivity periods but may only extend the existing one under limited conditions. In line with the legislative purpose, a specific focus could be put on breakthrough orphan medicinal products, which are eligible for the maximum orphan market exclusivity of 11 years. 

3. “Bolar” exemption

What is the scope of the new "Bolar” exemption?

The current “Bolar” exemption, which allows generic or biosimilar marketing authorization applicants to conduct necessary studies and trials during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, has been inconsistently transposed across the EU.

The new directive aims to harmonize the application of the “Bolar” exemption and clarify its scope. Accordingly, the conduct of the necessary studies, trials and other activities for the following purposes will not be considered a patent/ SPC infringement:

  • Obtaining a generic, biosimilar, hybrid or bio-hybrid marketing authorization
  • Conducting health technology assessment
  • Obtaining pricing and reimbursement approval
  • Complying with subsequent practical requirements associated with the aforementioned activities
  • Submitting an application on procurement tenders for the sale of the medicinal product after the expiry of patent or SPC

Any activity conducted for these purposes, including the offer, manufacture, sale, storage, import, use and purchase of medicinal products or processes, including by third party suppliers and service providers, will also be exempt from patent or SPC infringement proceedings.

How can the industry prepare?

Innovators generally have to expect earlier generic/ biosimilar market entries and resulting revenue losses. Therefore, early planning and robust IP portfolio strategies as well as commercial preparedness for generic/ biosimilar market entries will become even more important.

4. Next steps

What are the next steps in the legislative procedure?

The provisional agreement must now be endorsed by both the Council of the European Union and the European Parliament before being formally adopted. The new directive and regulation will enter into force upon publication in the EU's Official Journal. The regulation will become applicable in 2028, two years after publication in the EU's Official Journal (Article 181 of the new regulation), the new directive needs to be transposed into national law of the member states at the same time (Article 219 of the new directive).

What transitional provisions apply?

Regulatory data and market protection: The new regulatory data and market protection periods will only apply to marketing authorization applications submitted after the new regulation and directive become applicable in 2028. For applications submitted before that date, the current regulatory exclusivity periods under Article 14(11) of Regulation (EC) No 726/2004 and Article 10 of Directive 2001/83/EC will continue to apply (Article 180(4) of the regulation and Article 218(5) of the new directive).

Validity of orphan designations: For orphan designations granted before the new regulation becomes applicable, the seven-year validity period shall begin to run from the date of application of the new regulation (Article 180(7) of the new regulation).

Period of orphan market exclusivity: For orphan medicinal products with initial marketing authorization applications submitted before the new regulation becomes applicable, the exclusivity periods referred to in Article 8(1) of Regulation (EC) No 141/2000 will continue to apply. For any subsequent applications for an orphan medicinal product containing the same active substance, as well as for marketing authorization applications of orphan medicinal products submitted after applicability of the regulation the exclusivity provisions of the new regulation will apply (Article 180(7a) of the new regulation).

“Bolar” exemption: Since there is no explicit transitional provision for the new “Bolar” exemption, it will apply 24 months after the directive enters into force, when the member states have transposed it into national law (Article 219 of the new directive).

 5. Overview of new regulatory and orphan exclusivities

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