Evaluation of Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products, and Regulation (EC) 1610/96 concerning the creation of a supplementary protection certificate for plant protection products

Executive summary

1.Background

This evaluation concerns Regulations 469/2009 and 1610/96 on supplementary protection certificates (SPCs). It is relevant to the analysis of pharmaceutical incentives called for by the June 2016 Health Council. Its findings will feed into the implementation of the intellectual property action plan and the pharmaceutical strategy for Europe.

SPCs are intellectual property rights that may extend by up to 5.5 years the protection conferred by a patent on a medicinal or plant protection product (PPP).

The objectives identified in the intervention logic underpinning the Regulations are to:

(1)encourage global R&D in the field of new active ingredients of medicines and PPPs;

(2)attract R&D centres and jobs to the EU and prevent R&D relocation;

(3)promote a uniform SPC system in the EU.

This evaluation relies on legal and economic studies as well as on several surveys.

2.Main Findings

As regards the effectiveness of the SPC Regulations in achieving their objectives:

·SPCs promote innovation and the availability of new medicines and PPPs, as they help companies recoup their R&D investments.

·SPCs promote R&D in Europe to some extent. The EU remains a hub for R&D in the fields of pharmaceuticals and PPPs despite strong global competition. However, R&D location also depends on other factors such as the local availability of skilled labour, public funding and tax schemes. Patents and SPCs may be especially helpful in supporting innovative EU pharmaceutical SMEs, which have fewer resources to embark on lengthy development cycles.

·Although the SPC regimes provide a common framework within the EU, they are administered at national level. This causes fragmentation, leading to high costs and imposing an administrative burden on applicants (especially SMEs) and national administrations. It also leads to legal uncertainty, as the scope of protection can differ across the EU. This has a negative impact on SPC users and generic makers.

·The negative effects of fragmentation are amplified by a lack of transparency, especially from a cross-border perspective, making it difficult to trace what SPC protection exists for which products in which Member States. This affects both SPC holders and generics manufacturers.

As regards efficiency, the SPC system appears to be reasonably balanced. SPCs may delay the market entry of generic medicines and PPPs, which may negatively affect the accessibility and affordability of medicines and PPPs. (For a sample of 232 medicines, we estimate that the SPC protection adds 13% of gross profits during the first 12.5 years after market launch). However, this negative effect is offset by the need for companies to recover investments in R&D, amid a steady increase in timelines and the costs of developing new products, and rising global competition. Moreover, SPC protection affects only a fraction of all medicines and PPPs. In many cases it is not the last protection to expire.

The SPC system remains relevant today for the following reasons.

·Its three objectives remain of major political importance.