How's it going for pharma SMEs in the EU?
In the EU, there are regulations - lots of them. There's even a specific regulation for micro, small and medium-sized enterprises (SMEs) in the pharma sector. The EU is seeking opinions on support for pharmaceutical SMEs.
The SME Regulation relates to:
- Regulation(EC) No726/2004, which is about EU centrally authorised products.
- Regulation(EC) No297/95, which allows the EMA to charge fees.
- Recommendation 2003/361/EC, which sets out the criteria for qualification as micro, small or medium-sized enterprises.
In August, the EMA published a survey intended to collect feedback from SMEs and interested stakeholder organisations. It provides SMEs with an opportunity to let the EMA know about pain points and experience of working with the EMA, as well as a chance to praise or grumble about the incentives on offer (or offer suggestions for alternatives). The survey results will be discussed at a roundtable meeting in 2025 and the EMA will publish a report after that.
The EMA has provided reassurance that contributions and contributors will remain anonymous, so there are no public relations or privacy reasons to hold back - although clearly, it would be sensible to play nicely with the EMA.
Most successful businesses will start small, grow to medium-sized, and then either decide to stay happily and comfortably in that bracket or seek to scale up or enter into a corporate transaction to propel them beyond SME status. In the Commission's summary of Recommendation 2003/361/EC, "SMEs represent 99 % of all businesses in the EU. They are the backbone of its economy. They generate 2 out of every 3 jobs. In 2013, over 21 million SMEs provided almost 90 million jobs throughout the EU. They stimulate a sense of entrepreneurship and innovation, helping to foster European competitiveness, economic growth and employment.".
SMEs are and will always be a very important part of the pharma sector.
The consultation can be found on the EMA's website. Have your say. The deadline is 16 September 2024.
The survey points out that these incentives are available:
- Financial fee incentives pre-authorisation
- Financial fee incentives post-authorisation (including Pharmacovigilance fee incentives)
- Regulatory assistance services (pre- and post-authorisation)
- Support to EMA’s clinical data publication (Policy 0070)
- Support to Priority Medicines Scheme (PRIME)
- SME briefing meetings
- Translation assistance
- Advanced Therapies incentives (certification)
- Public SME register
- Training events (workshops and SME info days)
- SME user guide
- SME newsletter
The EMA is clearly identifying medicine shortages as an issue for SMEs, although it has not provided background information on its concerns. The laws and regulatory guidance documents relating to EU shortages (and preventing them) are detailed and complex. More information can be found here. In short, known or suspected shortages need to be reported to regulators.
Do you qualify as an SME and are you accessing SME support in the EU? Is it working? Have you experienced problems with shortages? We'd love to hear from you. You can contact Harry Jennings in our Pharmaceuticals and Life Sciences team on 07789 533 122, or complete the form below.