The European Parliament defines its negotiating position.

UM – 02/2024

When the European Parliament meets in Strasbourg on 27 February, it will also adopt its position on most of the dossiers enshrined in the legislative package for the protection of intellectual property. These include the two dossiers on protection certificates for medicinal products. The decision in the plenary meeting will be based on the reports by Tiemo Wölken (S&D, DE) on the unitary Supplementary Protection Certificate and the revision of the Regulation on the Supplementary Protection Certificate for medicinal products, which were voted on by the responsible European Parliament's Committee on Legal Affairs (JURI) on 24 January.

Competition vs. innovative ability

Even if further amendments are possible in the plenary meeting, the JURI reports show the negotiating priorities with which Parliament's negotiators will enter the trialogue. The guiding principle for the MEPs in the committee was that, as with the reform of pharmaceutical legislation, it is crucial to maintain a healthy balance between the timely entry of generics and biosimilars and thus competition on the one hand, and the preservation of the innovation and competitiveness of European pharmaceutical manufacturers on the other. 

Market presence via licence

Protection certificates act like patents and protect an original preparation from competition. Their purpose is to compensate the manufacturer for the sometimes long and complex procedures required to obtain marketing authorisation for a product through additional protection periods of up to five years. MEPs want to use the introduction of a unitary European protection certificate as an opportunity to develop it into an instrument that helps to ensure that new medicinal products are available on as many markets as possible. To this end, the certificate holder should be able to grant the rights from it by licence if there is no own interest in marketing it.

Equal rights for all

However, in order to protect European manufacturers from competitive disadvantages, it should also be possible to restrict the rights arising from protection certificates. Namely, in cases where the medicinal product is to be manufactured exclusively for export to third countries. After all, the property rights would not apply to competitors from third countries either way. In these cases, it should be possible to manufacture the medicinal product without the consent of the certificate holder. 

For more process efficiency

The JURI is also of the opinion that in certain cases it may be necessary to bring about decisions on the granting of supplementary protection certificates more quickly. An accelerated review procedure is to be set up for this purpose. All applications, statements, complaints and other administrative processes must be carried out electronically to ensure procedural efficiency. The competent offices - the European Union Intellectual Property Office (EUIPO) based in Alicante in the case of the unitary European certificate and the national patent offices in the case of national Supplementary Protection Certificates - shall be obliged to decide on the applications within six months, or four months in case of an accelerated procedure. The deadlines were apparently so important to the MEPs that they did not want to leave their definition up to the implementing acts of the European Commission.

Transparency is a must

The European Commission's draft regulations already contained requirements for the establishment of registers - both for the unitary supplementary certificate and for the certificates to be issued nationally. In addition to the basic details of the application, these should also summarise certificate validity periods and procedural information. JURI urges that these registers be made publicly accessible and that they also include information on direct public financial support for the development of the product. However, the committee does not go as far as the Green MEPs did with the pharmaceutical reform. The Green shadow rapporteurs had suggested that the dates of expiry of patent protection and regulatory protection be made transparent together. A demand that would see generic competition fostered, and which the DSV fully agrees on. Perhaps this idea could be taken up in the trialogue on the reform of intellectual property protection?