Biopharma industry remains mixed over EU reform proposals, finds GlobalData

Respondents’ opinions on the impact of EU reform proposals were mixed, with the percentage of participants expressing positive, negative, or neutral views remaining varied

Reforms to the European Union’s (EU) general pharmaceutical legislation emerge as one of the key policy developments affecting the operating environment for the pharma industry. In a survey, respondents’ opinions on the impact of EU reform proposals were mixed, with the percentage of participants expressing positive, negative, or neutral views remaining varied, according to GlobalData.

GlobalData’s recent survey*, “The State of the Biopharmaceutical Industry 2024 (mid-year update)”, finds that pharma sector leaders are deeply ambivalent over the pros and cons of planned EU reform measures. The lack of a uniform opinion for or against probably reflects the different impacts that the reforms are expected to have on innovative, generic, and branded generic companies, as well as uncertainty over which reforms are likely to be finalised and implemented.

Eoin Ryan, Managing Analyst at GlobalData, comments, “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.”

Another factor that may have contributed to the nearly equal three-way split in the industry’s response to the survey question is that the future of pharma reform is still uncertain in many aspects. Trialogue discussions aimed at finalising the reform package seem likely to open up the possibility of further changes. Moreover, the emergence of political crises in certain EU countries, and difficulties forming effective governments after elections in Belgium and Bulgaria, among others, risk complicating EU negotiations.

In addition, the possible growth of right-wing, populist, and anti-EU political parties in June 2024’s European Parliament elections may exacerbate policy differences in upcoming negotiations between EU institutions and could result in a greater willingness to dilute more controversial parts of the EU pharma reforms.

Ryan concludes, “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 fielded with 124 healthcare industry professionals globally from April 4, 2024 to May 10, 2024