The European Parliament provided an update on the reform process for the modernisation of the European Union's pharmaceutical legislation.

The legislative package consists of a directive and a regulation, both of which have been approved with amendments that appear to be less rigid than the first drafts, in some key points, where they take into account the grievances expressed in recent months by the pharmaceutical industry, in particular:

- the minimum regulatory period of data protection (during which other companies cannot access product data), which in the Commission's draft had been reduced from 8 to 6 years, is extended 7.5 years, i.e. almost to current levels.

- market protection (during which generics or biosimilars cannot be marketed) remains at two years, as today and as in the executive text.

Further premium regulatory protection can be added, according to the logic promoted by the Commission.

In particular, a maximum of 8.5 years of data protection will be possible, based on new conditions introduced by the European Parliament:

- 12 months of additional data protection if the product fulfils an unmet medical need;

- 6 months if comparative clinical trials are conducted;

- 6 months if a significant part of the research and product development takes place in the EU and at least partly in cooperation with EU research institutions.

An additional 12 months can be added to the existing market protection if the company obtains a marketing authorisation for an additional therapeutic indication that provides significant clinical benefit over existing therapies. Orphan drugs developed to treat rare diseases may, on the other hand, benefit from up to 11 years of market exclusivity if they address a high unmet medical need.

The new rules for marketing authorisations (MAs) for medicines change the system from the European Commission's initial proposal. Instead of requiring marketing in all EU markets within two years of the EMA's go-ahead in order to achieve an extension of regulatory protection, the new system is more flexible and aimed at helping EU countries with limited administrative resources to manage marketing procedures. Procedures for entering a national market will only be initiated at the specific request of the country concerned.

The reform package for the EU pharmaceutical system, approved by the European Parliament, is not yet final. The baton now passes to the new Parliament that will emerge from the June elections. It will be up to the newly elected representatives to negotiate with the member states to find a final agreement on the law, and the EU Council will also have to adopt a position on the reform before arriving at a final version.