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“If that change becomes law, generic entry will b
e 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.” S 44 | NORDICLIFESCIENCE.ORG econdly, 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-ofstock 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 February, and with 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 hosted a webinar on new incentives in AMR management on February 15th – with more activities certain to come in the springtime. ANASTASIA FLANAGAN, MARKETING MANAGER AND LOVISA ROSENQUIST, DIRECTOR, POST-MARKETING PROJECTS, AREX ADVISOR AREXADVISOR.COM 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. NLS Impactful meetings further down the line are scheduled for the following dates: 6-7 MARCH High-level meeting on antimicrobial resistance, Stockholm 14 MARCH, 13 JUNE Meeting for the Employment, Social Policy, Health and Consumer Affairs Council with a focus on health, Brussels 20-21 APRIL High level meeting of combatting loneliness, Stockholm 4-5 MAY Informal meeting of health ministers, Stockholm 5-6 MAY Visit by attachés to the Working Party on Public health, Stockholm 19-20 JUNE Meeting on Global Health, Stockholm BUSINESS // COMMENTARY