For six months starting in January 2023 Sweden will hold the Presidency of the Council of the European Union. It is much more than an honorary role, encompassing an opportunity for Sweden to both set new guidelines and see to the implementation of important existing policies.
The guiding document for Sweden’s Presidency is the Programme detailing the actions that will be taken – and the principles that underpin those actions. In the case of the pharmaceutical sector, the actions are very specific and will create impact for companies established on the EU market – or on their way to being that. We find a good summary in the section named “Employment, social policy, health care and consumer affairs”.
Firstly, what is clear is that legislation is going to be a strong priority in the coming months. The Programme states that the proposals for the major update of pharmaceutical legislation, including the overarching directive 2001/83 and the paediatric and orphan regulations, will be published. Other important legislative proposals will be advanced, such as the Regulation for a European Health Data Space. There will be a concerted effort to renew the EU Global Health Strategy. Another introduction which will affect almost all industry stakeholders is an update to the EMA (European Medicines Agency) fee structure. Furthermore, there will be an emphasis on the Medical Devices Regulation, which has already been adopted but has not yet seen a full-scale implementation, partly due to the lack of Notified Bodies.
“Sweden will use its time in office to coordinate a joint EU stance in discussions towards an international pandemic treaty, as well as supplementary amendments to other International Health Regulations.”
Secondly, what we see in the Programme is a willingness to learn from the lessons of the COVID pandemic response, and to shift action from corrective to preventative, whenever possible. Sweden will use its time in office to coordinate a joint EU stance in discussions towards an international pandemic treaty, as well as supplementary amendments to other International Health Regulations. Further deepening the safety focus, effort will be made to prevent shortages of important medicines and to improve access.
Finally, a range of specific health issues will be given extra attention during the coming months. Here we may name the European Beat the Cancer Plan; a call for continued prudence in the use of antibiotics for human and veterinary applications; and the recognition – for what must be the first time – of the impact of loneliness on the public healthcare system.
“The EU regulatory reality, which is anyhow in a continuous state of flux, will undergo some truly consequential changes in 2023.”
Considering all of the above, we conclude that the EU regulatory reality, which is anyhow in a continuous state of flux, will undergo some truly consequential changes in 2023. To stay abreast of new regulations, top-of-the-line regulatory competence is a must.