Access to Medicines 

France

  • The French Haute Autorité de Santé (HAS) has announced that it will review the basis for evaluating applications for early access to innovative drugs with its work expected to be completed early in 2025. The review will consider the minimum data requirements for early access to ensure informed decision making, patient safety and regulatory and ethical considerations. For further information on the review framework, see here 

Artificial Intelligence 

EU

  • On 12th July the EU Artificial Intelligence (AI) Act was published in the Official Journal of the European Union. The Act will enter into force on 1st August 2024 and will apply directly in all member states. The provisions of the Act and date of application in force depend on the categorisation of risk. See Official Journal publication for further information. 

 

  • The European Data Protection Supervisor (EDPS) and The University of Karlstad are hosting an Internet Privacy Engineering Network (IPEN) event on “Human supervision of automated decisions” on 3 September 2024. The aim of the event is to promote discussion on challenging questions related to AI. See here for further information.  

Clinical Trials 

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a press release on the EU-X-CT Cross Border Clinical Trials Initiative, detailing the work it has been doing with the European Forum for Good Clinical Practice (EFGCP) identifying barriers to participation in cross-border clinical trials and developing recommendations to overcome these challenges. Following publication of a Report and Six Point Action Plan, the Initiative is now working on drafting recommendations for cross-border trial access, which are expected to be shared for public comment by the end of 2024. 

 

Code of Practice 

UK

 

  • Novo Nordisk has received a public reprimand for failure to disclose transfers of value of approximately £7.8 million. The failures to disclose related to over 150 different bodies, mainly healthcare organisations. See AUTH/3847/11/23  for further information.   

Competition Law 

EU

  • The European Court of Justice (ECJ) has largely confirmed the General Court’s judgement in the perindopril pay for delay patent settlement case, confirming infringement of EU competition law. See ECJ press release for more information.  

Competitiveness Strategy 

EU

  • EFPIA’s Director General has commented on the EU Strategic Agenda 2024-2029: “We are pleased to see EU leaders aligning on the necessity of a new competitiveness deal and on the importance of health and pharmaceuticals as key sectors for Europe’s future. Over the last decades we have seen an erosion of the R&D base in Europe. After losing its crown to the US as the global leader in pharmaceutical innovation in 2000, Europe is now third behind China in terms of launching new active substances globally. As we begin a new EU mandate, the focus on competitiveness of the Strategic Agenda gives us an opportunity to restore Europe’s leadership in life sciences.” See EFPIA statement for further information. 

UK

Data Privacy 

EU

  • On 1st July the EU-Japan deal on cross border data flows entered into force. See EU Commission press release for further information. 

UK

  • The Information Commissioner’s Office (ICO) has announced it will hold its annual Data Protection Practitioners’ Conference (DPPC) online on Tuesday 8th October 2024. See here for further information. 

Intellectual Property 

EU

  • The European Council has adopted its position on the compulsory licensing regulation, seeking to protect intellectual property rights holders by limiting the legislative acts which can activate the crisis or emergency mode under which a Union compulsory license can be issued. See European Council press release for further information. 

Medicines Shortages 

Denmark

  • On 1st July the new Danish Act on Stockpiling Medicines came into force, requiring companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. See press release of the Danish Medicines Agency for further information. 

Pricing and Reimbursement 

Germany

  • On 4th July, the German Bundestag passed significant amendments to Germany’s drug pricing and reimbursement laws, including an option for pharmaceutical companies to keep pricing resulting from the AMNOG market access process confidential, thus preventing the price from being used in reference pricing in other countries. In order to meet the threshold for confidential pricing, companies need to demonstrate local research and development activities in Germany and pay a 9% discount on the agreed AMNOG reimbursement price. See here for the modified version (in German) of the proposed recommendation accepted by the German Parliament.  

Regulatory 

EU

  • The European Medicines Agency has opened a consultation on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis. The consultation is open until 30 September 2024. See here for the concept paper and further information on the consultation. 

 

  • See here for the European Medicines Agency July 2024 issue of the Human Medicines Highlights newsletter, including new information on medicines and CHMP opinions on new medicines.  

Research and Development 

EU

  • EFPIA has issued a statement on the European Framework Programme for Research and Innovation (FP10) urging the EU Institutions to significantly increase the current budget in view of FP10 and to make pan-European collaborative research the cornerstone of FP10. See here for the full EFPIA statement. 

 

  • EFPIA has published the latest quarterly edition of NIRO (Navigating Innovation and Research Opportunities), which lists research and innovation funding opportunities currently available from a variety of programmes and initiatives, as well as forthcoming opportunities. See EFPIA statement for further information. 

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

You can also stay informed and ahead of the curve by subscribing to our newsletter and following us on LinkedIn.