Biopharma industry’s response to EU reform proposals varies: GlobalData

Survey reveals mixed sentiments among industry leaders regarding impending EU regulatory changes

New Delhi: The biopharmaceutical sector is navigating mixed sentiments regarding proposed reforms to the European Union’s (EU) pharmaceutical legislation, according to findings from GlobalData, a prominent data and analytics firm.
Survey results revealed a diverse range of opinions among industry stakeholders, with views on the potential impact of EU reform proposals varying significantly.
GlobalData’s recent survey, titled “The State of the Biopharmaceutical Industry 2024 (mid-year update),” shed light on the complex attitudes within the pharmaceutical sector towards impending EU regulatory changes. The survey highlighted a lack of consensus among industry leaders, showcasing a balanced distribution of positive, negative, and neutral perspectives regarding the proposed reforms.
Eoin Ryan, Managing Analyst at GlobalData, remarked, The overhaul of pharma legislation in the EU has the power to affect nearly every aspect of medicine regulation, from marketing exclusivity, access, to addressing innovation incentives. However, the survey was conducted at a time when some of the more contentious proposals, such as those that promoted the idea of linking conditional data exclusivity extensions to near-simultaneous market launches in the EU, were viable policy options. The EU authorities have since abandoned that concept and softened others. This may inject more optimism into industry views if the survey is rerun.”
One significant aspect influencing the varied responses is the ongoing evolution of EU policy discussions, characterized by trialogue negotiations and the shifting political landscape within member states. The intricacies of EU governance, compounded by political challenges in certain countries, add layers of complexity to the reform process, potentially impacting the final outcomes.
Ryan concluded, “The bottom line is that pharma still lacks clarity on what type of reforms are likely to emerge. But, with so much uncertainty in the air, the pharma sector must be slightly hopeful of potentially winning concessions that could potentially make some parts of the reform proposals more palatable.”
“There remains significant momentum among some policymakers for further amendments in several areas that would be beneficial to the competitiveness of the innovative pharmaceutical sector in the EU, hence the overall neutral or even slightly optimistic views evident from the survey results.”
GlobalData’s survey, conducted from April 4, 2024, to May 10, 2024, engaged 124 healthcare professionals globally, providing valuable insights into the industry’s outlook on EU regulatory reforms.