Data protection periods

The current period of data exclusivity is known as the “8+2+(1)” regime, whereby innovators have eight years of data protection from the date of marketing authorisation, followed by two years of marketing protection and a further one year of protection in some circumstances. This will now be replaced by an “8+1+1+1” model. In this model the marketing protection period is reduced to one year, with the possibility of a one-year extension in certain circumstances to address unmet clinical needs. A further one-year extension is available for drugs with an additional indication. Whilst the overall period available remains unchanged at eleven years, there will be an increased hurdle to obtaining the full period.

Orphan drugs

So-called “orphan” diseases are rare diseases attracting limited funding and research. All orphan products currently benefit from ten years of market exclusivity. Under the new regime all orphan products will be entitled to nine years of market exclusivity, with the possibility of a further two years for products to treat diseases for which no therapy is currently available. A further extension of twelve months may be available for a new therapeutic indication covering a different orphan condition (provided the approval is obtained at least two years prior to expiry of the marketing authorisation). Orphan market exclusivity prevents the approval of all equivalent products, innovator or generic/biosimilar. Authorisation for new orphan products or indications will only take effect after existing exclusivity expires.

Antimicrobial resistance 

The new legislation seeks to improve incentives for tackling the issue of antimicrobial resistance. A transferable exclusivity voucher (TEV) has been introduced for priority antimicrobial drugs, wherein the holder of the voucher benefits from twelve additional months of regulatory data protection for any one of their authorised products (not necessarily the antimicrobial drug). The voucher may be sold to other pharmaceutical companies. The introduction of the TEV provides a new financial incentive to pharmaceutical companies to develop antimicrobial products.

Generics and biosimilars 

The new legislation also aims to streamline the launch of generic and biosimilar products. For example, there are changes to the data requirements and an expansion of the scope of the Bolar exemption. The Bolar exemption allows the use of generics/biosimilars for studies and trials required for marketing authorisation to be carried out prior to expiry of a patent or SPC without being considered an infringing act. The scope of the exemption is now significantly increased to cover preparatory activities related to marketing authorisation, health technology assessment applications, pricing and reimbursement applications, and participation in public tenders. The exemption now covers acts that would previously have been considered infringing acts (for example submissions for procurement tenders, that is, offering for sale). The changes aim to enable a more expedient entry to the market for generic and biosimilar manufacturers.

Paediatric drugs

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines must include the results of studies as described in an agreed PIP, unless the medicine is exempt. Under the new legislation PIPs will need to be submitted at an earlier stage with the aim of improving access to paediatric treatments. Furthermore, if the holder of the marketing authorisation withdraws a product from sale, they must give a notice period of twelve months and must ensure that paediatric patients can continue to access the drug (for example by transferring the marketing authorisation to a different manufacturer).

Once formally adopted, the regulation and the directive will enter into force on the twentieth day following their publication in the Official Journal of the European Union. Member states will have 24 months from the directive’s entry into force to transpose it into domestic law. 

Useful links

• Council of the European Union, directive on the union code relating to medicinal products for human use - analysis of the final compromise text with a view to agreement (PDF): dycip.com/eu-directive-analysis 
• Council of the European Union, regulation laying down union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency - analysis of the final compromise text with a view to agreement (PDF): dycip.com/eu-regulation-analysis