The Technopolis study questions the importance of protection certificates for accessing medicines.

UM – 11/2023

A study led by the Technopolisgroup policy consultants has analysed the legislative proposals covering supplementary protection certificates (SPCs) and the introduction of a unitary supplementary certificate. The client - the European Parliament's Committee on Legal Affairs (JURI) - was interested in analysing the potential impact of the European Commission`s proposals for further developing the SPC system for accessing innovative medicines within the EU.

The system remains complex

A reminder: an SPC is intended to compensate for the sometimes long period between patent application and market approval by extending market protection by up to five years. Its further development is part of the reform of intellectual property rights that was initiated by the European Commission on 27 April this year. In addition to the existing system of issuing national SPCs for nationally authorised products, a centralised procedure for issuing national SPCs will be introduced in some or all member states. There will also be a standardised SPC for use throughout Europe, which will complement the standardised European patent that has already been introduced. As combining the procedures will also be possible, this means that there will be four ways to obtain an SPC.

Simplifications are questionable

The Technopolisgroup's consultants also concluded that the planned new system will simplify the application procedure to be used for standardised SPCs by creating a single administrative office for applications and payments, i.e. the EUIPO (EU Intellectual Property Office). However, as the current system will be maintained in parallel, the situation for non-standardised SPCs will remain complex, as separate assessment notices for each country might result in parallel appeal and objection procedures. There is also a risk that the centralised procedure for national SPCs will lead to parallel positive and negative assessment decisions, as the application requirements might differ in the member states.

Fewer SPCs - more competition

However, positive effects are also conceivable. Prompt access to generics could be improved if extended appeal options result in fewer SPCs being granted. It is unlikely that the current national differences in handling SPCs will play a significant role in the unequal access to innovative medicines. This is largely determined by national market characteristics - i.e. market size, availability of alternative treatments, pricing and reimbursement - and not by the SPCs.

Less can be more when it comes to intellectual property rights

The study followed a similar line to a study commissioned by the Committee on the Future of Science and Technology in the European Parliament that surprisingly was not presented for discussion. This has caused a bit of a political stir at Brussels level in recent weeks. The tenor of the "Improving access to medicines and promoting pharmaceutical innovation" study was that the generous intellectual property rights granted for developing medicines do little to make it easier to access medicines in Europe. Prepayment models, joint procurement or publicly funded research would be more effective.