When it comes to exclusivity in the pharmaceutical and biopharmaceutical fields, patents and supplementary protection certificates (SPCs) are not the only games in town. In Europe, it is important to consider another layer of exclusivity, associated with regulatory data.
Before a medicinal product can be put on the market in Europe, it must receive a marketing authorisation (MA). For new active substances, a full application must be made. As part of a full application, the applicant must provide certain information including sufficient preclinical and clinical trial data to demonstrate that the product is safe and effective.
For active substances that are not new, a MA may be granted based on an ‘abridged application’, which can refer to the information provided as part of the application for a first ‘full application’. This allows a company to demonstrate the efficacy and safety of a product whilst avoiding excessive and repetitive testing on human subjects. This is the route commonly sought by generic companies.
A company that has secured a MA on a product for the first time benefits from a period of ‘data exclusivity’ in which the market authorisation holder’s pre-clinical and clinical trial data cannot be used in an abridged application by a third party. However, it does not prevent another company submitting a full-application based on their own clinical trials.
- The 8+2+1 regime
Data exclusivity lasts for eight years from grant of the MA. After eight years, a third party can use the clinical trial data of the original MA in their applications, but they are not able to market their product until after ten years from the grant of the MA.
In some circumstances, the ten year period can be extended by one year to a maximum of eleven years. This may be possible if, during the first eight years, the market authorisation holder obtains an authorisation for one or more new therapeutic indications which are held to bring a significant clinical benefit in comparison with existing therapies. A significant clinical benefit could be improved efficacy, improved safety, or a major contribution to patient care (such as a new mode of administration which can be easily self-administered). One example of where a new indication could bring significant clinical benefit is where there is no existing treatment at all for that particular disease.
- ‘Stand-alone’ shorter periods of data exclusivity
- Where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity can be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication.
- Medicinal products are classified according to whether or not they are subject to a medical prescription. Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the regulatory authority shall not refer to the results of those tests or trials when examining another application by another applicant for or holder of a MA for a change of classification of the same substance for one year after the initial change was authorised. So, if classification data is changed, there is a data exclusivity period of one year.
In Europe, a market authorisation holder may obtain ten years of market exclusivity following grant of a MA for an orphan drug. An orphan drug is one which is intended for the diagnosis, prevention or treatment of:
a) a life-threatening or chronically debilitating condition affecting not more than five in 10,000 people) when the application is made; or
b) a life-threatening, seriously debilitating or serious and chronic condition that, without incentives it is unlikely that marketing the medicine would generate sufficient return to justify the necessary investment.
No satisfactory method of diagnosis, prevention or treatment of the condition concerned must already be available, or, if such a method exists, the drug must be of significant benefit to those affected by the condition.
An additional two years of market exclusivity may be available for paediatric medicines, if certain paediatric studies are undertaken.
An application for orphan drug status is separate to a MA application, so orphan drug exclusivity is independent of data exclusivity. Consequently, a drug designated as an orphan drug may benefit from a market exclusivity which runs in parallel with the basic market exclusivity if the drug is also authorised (through a separate MA) for other indications. Any additional orphan indication for the same product benefits from its own period of marketing exclusivity.
What are the implications of Brexit?
In Europe, exclusivity associated with regulatory data is governed by European Union Directives and Regulations. So what will happen in the UK post-brexit?
It is expected that transitional legislation will ensure that ‘centrally authorised products’ (i.e. those products which have been through the European Medicines Agency (EMA) approval process resulting in a single approval for the whole of the EU) will benefit from an automatic UK MA.
A Directive concerning the 8+2+1 regime has already been implemented in UK law by the Medicines Act, and so UK law will largely replicate EU law, at least initially. The UK also has its own regulatory body which handles MAs in the UK (the Medicines and Healthcare products Regulatory Agency (MHRA)), which deals with applications for authorisations of medicinal products. However, in terms of administration, it is not clear whether MAs issued by the MHRA will automatically become valid in the UK, or if separate applications would be required in the EU and UK. One proposal has been implementation of a new assessment procedure based on a review of a positive opinion from the EMA. If MAs issued by the EMA do not automatically become valid in the UK, it is likely to place a significant extra administrative burden on the MHRA and market authorisation seekers.
Current EU law means that the MHRA does not have authority to grant MAs for all medicinal products for all medicines. Presently, certain types of medicines must be assessed in a central procedure by the EMA, such as cancer treatments and orphan drugs. So, if the MHRA is expected to begin examining applications for products that currently fall under the EMA’s authority, it may further add to their burden.
The EMA is based in London, but it appears likely that it will move to an EU state post-Brexit. It is anticipated that such a move is likely have a knock-on effect for users, such as delays in assessing applications.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.