EFPIA welcomes the publication of the Staff Working Document (SWD) on the evaluation of the Supplementary Protection Certificate (SPC) Regulation. ,

At its heart, the SPC is about stimulating the investment needed to bring new diagnostics, treatments and vaccines to meet the needs of patient across Europe and around the world. Bringing new therapies to patients is a long, complex, and risky process that, on average, takes 12 to 13 years and requires long-term and sustained investments. As recognized by the Copenhagen Economics study, “the average development time of a medicinal product – defined as the time that elapses from the first patent filing protecting the molecule to the first marketing authorisation of the final product in the EU – has increased from 10 years to 15 years in the analysed period based on our dataset” IP must incentivize and protect those investments. This is why in 1992, to restore the protection lost during the lengthy testing and clinical trials period, the EC introduced Supplementary Protection Certificates (SPCs). The EC recognized that:

“the period that elapses between the filing of an application for a patent for a new medicinal product and authorization to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into that research”.

Today, the SPC Regulation is even more relevant to ensure sustainable investments into researching and developing new medicines. According to the Copenhagen Economics study, the time taken to develop new products has increased and consequently, the effective protection period for the medicinal products in the dataset has declined from an average of 15 years to 13 years between 1996 to 2016. Without SPCs, this effective period of protection would have shrunk even further.

The CE study also confirms that there is a positive relationship between the effective protection period and the level of pharmaceutical research and development both in and outside the EU. Indeed, a strong SPC system is critical to ensuring that Europe can compete effectively for R&D investment and create a thriving environment to encourage world-class innovation.

Since the Regulation’s adoption 28 years ago, we have witnessed unprecedented evolutions of biopharmaceutical science. The CJEU has played a critical role in clarifying a number of questions raised by novel scientific and technological developments confirming the relevance of the SPC Regulation and its potential to accommodate complex situations going forward. Due to the speed and nature of innovation, changes to the SPC legislation would unlikely cover all eventualities and any new provision or wording would inevitably raise new questions for interpretation. We therefore agree with the Commission that case law is an appropriate tool to address the potential questions that national patent offices and courts may face in the future.

We also support the Commission’s continued efforts to further harmonise the EU SPC framework. We particularly await the entry into force of the Unitary Patent (UP) & Unified Patent Court and further support the creation of a unitary SPC (uSPC): one SPC for the EU rather than one SPC by country.

As recognised in the SWD and accompanying studies, the uSPC can simplify the application procedure, reduce duplication and facilitate a consistent application of the SPC Regulation across the EU. As the timeline for the entry into force of the UP/UPC system remains unknown, EFPIA commends the Commission’s reflection to provide an intermediate solution. A single application portal and a unified grant mechanism can be helpful steps towards a uSPC.

The EU’s Pharmaceutical Strategy, also published last week, aims to “support the competitiveness and innovative capacity of the EU’s pharmaceutical industry”. IP and within that framework the SPC is critical to realise that ambition, supporting European innovation, better patients outcomes, our resilience and our economic recovery.