Change is on the horizon for the regulatory data exclusivity and market protection regime in the European Union (EU), commonly referred to as “8+2+1” in reference to the number of years of regulatory protection that can be obtained. The proposed new regime reduces the basic period of data protection, but - in return for meeting additional requirements - the term of protection can be increased to exceed the current maximum term. Also changing is the EU’s generous exclusivity regime for Orphan Medicinal Products, and valuable regulatory protection ‘vouchers’ will be offered as an incentive for developing new anti-microbials that address the growing problem of antimicrobial resistance. When implemented, these changes will represent a significant change to the timelines of regulatory protection for medicinal products that have obtained marketing authorisation. We recommend that companies start planning now for these changes and what will be required in order to gain additional periods of exclusivity.
The European Parliament has recently voted to adopt a new draft Regulation and draft Directive from the European Commission. These proposals set out significant amendments to the rules regarding regulatory data exclusivity and market protection for new medicines in Europe. The draft legislation will need to be approved by the European Council, before implementation in the EU. Once implemented, the Regulation will take effect in all EU Member States on a defined date, likely to be three to four years from now.
Under the current regime, pharmaceutical companies enjoy generous periods of data exclusivity and market protection for innovative medicines with respect to generic medicines. In many cases, the ability to rely on such protection can be extremely valuable, especially if patent protection is about to expire or has expired. The current regime is often referred to as the “8+2+1” approach, since a new medicinal product can enjoy eight years of data exclusivity from the date the marketing authorisation (MA) is granted. During this time, no competitor is able to use the innovator company’s regulatory clinical trial data in its own submission for an MA for a generic medicine. The data exclusivity period is followed by two years of market protection, during which time a competitor cannot launch a rival product. An additional one year of market protection is available if a new therapeutic indication is developed for the medicine. The maximum period of regulatory protection is therefore currently 11 years.
The current proposal from the European Commission and European Parliament includes significant revisions to the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on paediatric medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively). The aim of the proposed revisions to the legal framework is to promote innovation, including for unmet medical needs and in the field of antimicrobials, as well as to ensure supply of and access to safe, affordable medicines in the EU.
The proposed regime reduces the basic period of data protection, but there are incentives to increase the term of protection in return for meeting additional requirements. The current draft Directive sets out the following:
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Companies marketing innovative medicines will have a period of regulatory data protection of seven years and six months from the date the MA was granted in the EU. This period of data protection can be extended by: (i) adding 12 months if the medicinal product addresses an unmet medical need1; (ii) adding six months if comparative clinical trials are conducted in accordance with advice provided by the European Medicines Agency; or (iii) adding six months if the MA holder demonstrates that a significant share of research and development, including preclinical and clinical, related to the medicinal product has been done within the EU and at least in part in collaboration with public entities located in the EU, such as university hospital institutes, centres of excellence or bioclusters. However, the total period of data protection cannot exceed eight years and six months.
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The data protection period is followed by two years of market protection. This period can be extended once by one year if, during the data protection period, the MA holder obtains an MA for an additional therapeutic indication and demonstrates a significant clinical benefit in comparison with existing therapies.
So, as standard, seven and a half years of data protection and two years of market protection will be provided (nine and a half years total), with the possibility of extending the total regulatory protection time to eleven and a half years by fulfilling specified criteria.
For medicines to treat rare diseases2, often referred to as ‘Orphan Medicinal Products’ (OMP), a market exclusivity period of 10 years is currently available, extendable by two years if a paediatric investigation plan (PIP) is completed. During this time of market exclusivity, a third party cannot launch any similar product onto the market, even if it generates its own clinical data; and even if the third party product is not structurally identical to the authorised OMP, unless it is shown to be clinically superior. Further, an OMP can currently benefit from a separate 10-year market exclusivity period for each new indication with an orphan designation for which an MA is obtained.
In the proposed new Regulation, the market exclusivity periods available for OMPs are scaled back. The standard duration of market exclusivity for an OMP will be nine years. If the OMP meets a high unmet medical need3 the duration will be 11 years.
In a significant change compared to the current regime, the period of market exclusivity for an OMP can be prolonged by 12 months, if at least two years before the end of the exclusivity period, the MA holder obtains an MA for one or more new therapeutic indications for a different orphan condition. This 12 month extension to the market exclusivity period can be obtained twice, if the new therapeutic indications are each for a different orphan condition. Accordingly, under the new Regulation, an OMP addressing a high unmet medical need could obtain up to 13 years of market exclusivity. Another significant change to OMP market exclusivity compared to the current regime is a new stipulation that the submission, validation and assessment of an application for, or the granting of, an MA for a similar medicinal product, including generics and biosimilars, is not prevented where the remainder of the duration of the initial market exclusivity of an OMP is less than two years. This is in line with the EU’s goal of improving affordability and patient access, and to encourage innovation to meet the medical needs of patients with rare diseases.
In view of the rise in antimicrobial resistance, further incentives are provided for developing antimicrobials. An applicant for an MA for a ‘priority antimicrobial’4 may request the grant of a transferable data exclusivity ‘voucher’ for one authorised medicinal product. The period of data protection bestowed by the voucher will be six, nine or 12 months, depending on the considered ranking of the antimicrobial product, based on the ‘WHO bacterial priority pathogen list’5 or an equivalent EU list. The data exclusivity voucher would be a valuable asset to its holder. According to the proposal, the MA holder can choose to extend the data protection period of the antimicrobial, or to use the voucher for any other centrally authorised product in its own portfolio. The voucher can even be sold to another MA holder for a different centrally authorised product, although there are some restrictions on the use of the voucher if it is transferred to another product. For example, the product must be within its first four years of regulatory data protection. Further, the voucher cannot be used for a product which already benefits from the maximum data protection period (see above).
Another proposed change relates to authorised medicinal products whose initial MA was granted over 25 years ago, or which have not previously benefitted from data protection. Where significant clinical benefit of a medicinal product is demonstrated for a new therapeutic indication that has not previously been authorised in the EU, a regulatory data protection period of four years will be provided.
The above comments represent a summary of the main changes to be brought into law in the EU. Although we expect it will be three to four years before these are implemented, companies should start considering how these changes will impact their products and pipeline. While the basic data protection period has been slightly reduced, at least some extensions appear to be readily obtainable, but will require forward planning. These extensions can result in the overall data protection time being equal to, or even longer than, the eight years provided in the “8+2+1” regime. There is much more detail in the draft laws so for specific queries, please seek further advice. If you have any questions or require further information, please do not hesitate to contact Andrea Coles, Benjamin Heller, Nick Bassil, or your regular advisor at Kilburn & Strode.
1 A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening or severely debilitating disease and there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; and the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.
2 To meet the definition of a rare disease, a prevalence of not more than 5 persons per 10,000 in the EU is generally regarded as the threshold
3 An orphan medicinal product shall be considered as addressing a high unmet medical need where it fulfils the following requirements:
(a) there is no medicinal product authorised in the Union for such condition; or
(b) where a medicinal product is authorised for such condition, in addition to having a significant benefit, it will bring exceptional therapeutic advancement and the use of the orphan medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.
4 As defined in the draft Directive: ‘An antimicrobial shall be considered a ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with regard to antimicrobial resistance and it has at least one of the following characteristics:
(a) it represents a new class of antimicrobials;
(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;
(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life-threatening infection.
5 WHO bacterial priority pathogens list, 2024: Bacterial pathogens of public health importance to guide research, development and strategies to prevent and control antimicrobial resistance