The EU Pharma Package - what will, and what will not, change following adoption
the EU Pharma Package has not yet been adopted, but it will be soon. The final European Parliament vote is anticipated for November 2026.
It is unlikely that there will be any fundamental changes in the provisions of either the current draft Directive that will replace Directive 2001/83/EC or, the current draft Regulation that will replace Regulation (EC) No 726/2004 prior to adoption.
While the new provisions will result in substantial changes to the existing rules governing medicinal products in the EU, there are provisions that will remain unchanged.
Data protection
The current 8 years’ data protection period is retained. This means, in principle, that other parties will be unable to rely on an innovator’s data to support an application for marketing authorisation of their product in the EU during this period.
The revised Bolar provisions may, however, compromise this protection.
Bolar provisions
The aim of the revised Bolar provisions is to permit access by generics from “day one” following expiry of IP rights.
Consequently, protection of patent rights, or supplementary protection certificates will not be considered to be infringed where necessary studies, trials, and other activities are conducted for the purposes of
obtaining a marketing authorisation for medicinal products;
conducting health technology assessment as defined in the HTA Regulation (Regulation (EU) 2021/2282);
obtaining pricing and reimbursement;
complying with subsequent practical requirements associated with the above activities;
submitting an application related to procurement tender procedures, in compliance with EU and national law.
As the circumstances in which this exemption applies are specifically defined in the draft Regulation EU Member States will no longer have a discretion concerning the scope of the exemption. This will hopefully lead to consistency in application of the Bolar provision throughout the EU.
Market exclusivity
The current 2 years of market exclusivity will be reduced to 1 year.
Moreover, the current additional 1 year’s market protection for innovative indications will be subject to compliance with specific obligations. These are:
conduct of comparative clinical trials and early application for marketing authorisation in the EU;
conduct of comparative clinical trials and clinical trials in more than one EU Member State;
where comparative clinical trials are not possible, conduct of clinical trials in more than one EU Member State and early application for marketing authorisation in the EU.
Early application in the EU occurs either, when an application for marketing authorisation is submitted first to a competent authority in the EU or, where it is submitted no later than 90 days following submission of the application for the first marketing authorisation for the new indication outside the EU.
An additional 1 years’ market protection is available for products that address an unmet medical need. Unmet medical need arises where at least one of the product’s therapeutic indications relates to a life threatening or severely debilitating disease and either of the following conditions are met:
there is no medicinal product authorised in the EU for such disease; or
the use of that medicinal product to treat such a disease results in clinically relevant improvement in efficacy or in safety with at least comparable efficacy, in comparison with existing medicinal products or other methods of prevention, diagnosis, or treatment authorised in the EU.
Maximum permitted combined data and market exclusivity is 11 years (or 12 if the transferrable exclusivity voucher for antimicrobials is applied)
Orphan medicinal products
The Orphan Products Regulation (Regulation (EC) No 141/2000) will be repealed and its provisions integrated into the forthcoming regulation.
The definition of an orphan medicinal product remains the same:
the condition affects not more than five in 10 000 persons in the EU when the application for an orphan designation is submitted;
no satisfactory method of prevention, diagnosis, or treatment of the condition has been authorised in the EU; or
where there is an existing method of prevention, diagnosis, or treatment, the medicinal product would be of significant benefit to those affected by that condition.
Basic market exclusivity related to orphan products will be reduced from 10 years to 9 years
2 additional years’ market exclusivity will be available for orphan products, also referred to as breakthrough orphan medicinal products, that address an unmet medical need. A medicinal product shall be considered to address an unmet medical need if at least one of its therapeutic indications relates to a life threatening or severely debilitating disease and either of the following conditions are met:
there is no medicinal product authorised in the EU for such disease; or
the use of that medicinal product for such a disease results in clinically relevant improvement in efficacy, or in safety with at least comparable efficacy, in comparison with existing medicinal products or other methods of prevention, diagnosis or treatment authorised in the EU.
New therapeutic indications for existing orphan medicinal products will no longer benefit from separate marketing authorisations and related market exclusivity. The draft Regulation provides that a 12-month extension of market exclusivity shall be permitted for a maximum of two new therapeutic indications.
Antimicrobial resistance
The introduction of a transferable exclusivity voucher intended to encourage pharmaceutical companies to help combat antimicrobial resistance through the development of priority antibiotics has garnered substantial interest. This voucher will provide an additional 1 year of market exclusivity for antibiotics that are priority antimicrobials and for which marketing authorisation has been granted. Transfer of the voucher is permitted. However, transfer includes a limitation intended to reduce the potential related impact of authorisation on national healthcare budgets by excluding use of the voucher in relation to products with annual gross sales of more than €490 million in the preceding four years.
The criteria for entitlement to benefit from the voucher are also provided. Priority antimicrobials are medicinal products that represent a real advancement against antimicrobial resistance. This will be considered to have occurred if:
the product addresses a multi-drug resistant organism;
the preclinical and clinical data demonstrate a significant clinical benefit with respect to antimicrobial resistance; and
it has at least one of the following characteristics:
its mechanism of action is distinctly different from that of any authorised antimicrobial in the EU;
it contains a new active substance that, when used either alone or in combination with other active substances, addresses a serious or life-threatening infection.
A priority antimicrobial shall be reserved for use exclusively in the treatment of humans for a period of 10 years to preserve the efficacy of those antimicrobials.
Supply
EU Member States will be granted power to require the marketing authorisation holder for a medicinal product, within 1 year of grant of marketing authorisation for the product, to place it on the national market of that EU Member State and to supply it in volumes sufficient to meet the needs of patients in the country as specified by that Member State. Failure by the manufacturer to fulfil this obligation within 3 years could result in withdrawal of the marketing authorisation for that country.
Will the review period change from 210 days?
Both the national timelines for procedures provided in the proposed Directive and that for the centralised procedure provided in the proposed Regulation have been reduced from 210 days to 180 days, excluding clock stops. As the existing 210 day period is often exceeded the reduced deadline may not always have practical effect.
The timeline for the existing accelerated procedure shall remain at 150 days.
Implementation period
Following its adoption, EU Member States will be required to implement the provisions of the draft Directive into their national laws within 24 months of the date of its entry into force.
Following its adoption, the draft Regulation will enter into force on the 20th day following its publication in the Official Journal of the European Union and enter into application from 24 months for this date.
The transitional period of 24 months from the date of its entry into force for which the draft Directive provides means that the Directive would only become applicable after this period has expired. With certain exceptions, applications to the national competent authorities of EU Member States for marketing authorisation that are submitted before entry into force of the Directive will be reviewed in accordance with Directive 2001/83EC. The related reference products will benefit from the data protection periods for which the existing Directive provides.
Where marketing authorisation applications by the centralised procedure are pending on the date of application of the draft Regulation, these shall be reviewed in accordance with Regulation (EC) No 726/2004. The related reference products will benefit from the data protection periods for which the existing Regulation provides.