For six months, starting in January 2023, Sweden has the Presidency of the Council of the European Union. It is much more than an honorary role, encompassing an opportunity for Sweden to both influence new guidelines and to drive to completion the implementation of important existing policies – not least those relevant for our industry.
A very own vantage point
When Sweden accepted the baton of the Presidency on January 1st, it followed in the footsteps of France and the Czech Republic, countries which held the same role in the first and second periods of 2022, respectively. Previous presidencies give a good insight into both the practicalities that Sweden will conform to – such as a live schedule of events for each priority track – and into the subtle way that the focal points of a Presidency may correlate to Sweden’s current challenges and unique strengths.
The Czech Presidency program, for example, introduced the topic “Health” with a mention of measures to combat the fallout of the COVID pandemic. With its below-average COVID vaccination rate at 65%, the Czech Republic gave the topic much airtime. Unsurprisingly, it is mentioned only in passing in Sweden’s programme for 2023.
Other subjects, such as the commitment to early detection of cancer and to the harmonization of health data, are found in both the Swedish and the Czech plans – as indeed in programs for several preceding presidencies.
What is truly different in the Swedish program is the clear focus on the pharmaceutical sector. The actions to be taken are very specific and will have an impact for all companies established on the EU market – or that are on their way to being that. We find a good summary in the section named “Employment, social policy, health care and consumer affairs.”
“If that change becomes law, generic entry will be possible already after eight years instead of the current ten, a rather drastic reduction in the length of time companies have in order to capitalize on massive investments made in the development phase.”
Firstly, what is clear is that legislation is going to be a strong priority in the coming months. The program states that the proposals for the major update of pharmaceutical legislation, including the overarching directive 2001/83 and the pediatric and orphan regulations, will be published. Specifically, according to policy news source Politico, the proposed amendments challenge the currently established period of market protection for new substances. If that change becomes law, generic entry will be possible already after eight years instead of the current ten, a rather drastic reduction in the length of time companies have in order to capitalize on massive investments made in the development phase. There could be a caveat to this as well, however. For companies willing to put the product on the market in all EU member states, the period of market protection will stay almost – but not quite – the same. This proposal will, without a doubt, generate a strong response.
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.
“This will certainly strike a chord with local industry stakeholders whilst we await the reaction to the Swedish government’s proposal on fines for undeclared out-of-stock situations.”
Secondly, what we see in the program is a willingness to learn from the lessons of the recent pandemic response, and to shift from corrective to preventative action, 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, efforts will be made to prevent shortages of important medicines and to improve access. This will certainly strike a chord with local industry stakeholders whilst we await the reaction to the Swedish government’s proposal on fines for undeclared out-of-stock situations.
Finally, a range of “traditional” 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 program in action
It is already March, and with more than a full month of the Swedish Presidency behind us, several of the 150 key meetings have already taken place. A high-level conference on cancer was held on February 1st, focusing on prevention, early detection, and equitable, data-driven cancer care.
Lif, the Association of the Research-Based Pharmaceutical Industry in Sweden, intends to cooperate with and take an active part in thought-exchange platforms connected to Sweden’s Presidency. To begin with, they have hosted a webinar on new incentives in AMR management on February 15th – with more activities certain to come in the springtime.
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.
Impactful meetings further down the line are scheduled for the following dates:
March 14th and June 13th – Meeting of the Employment, Social Policy, Health and Consumer Affairs Council with a focus on health (Brussels, Belgium)
April 20th-21st – High-level meeting on combatting loneliness (Stockholm, Sweden)
May 4th-5th – Informal meeting of health ministers (Stockholm, Sweden)
May 5th-6th – Visit by attachés to the Working Party on Public Health (Stockholm, Sweden)
June 19th-20th – Meeting on Global Health (Stockholm, Sweden)
Text by Dr. Anastasia Flanagan (left), Marketing Manager, and Lovisa Rosenquist (right), Director, Post-Marketing Projects, Arex Advisor
This Commentary was originally published in NLS magazine No 01 2023, out March 2023
