A Reconstruction and Validation of the Rationale Underlying the Ec Proposal to Make Regulatory Data Protection (RDP) Conditional upon Supply in EU Member States

Author(s)

Cueva Oemer S1, Seyedmousavi S1, Hasson O2, Jansen C3
1Inbeeo, London, UK, 2Inbeeo Ltd, London, LON, UK, 3Inbeeo, Amsterdam, NH, Netherlands

OBJECTIVES: The European Commission (EC) has proposed a revision of the European Union (EU) pharmaceutical legislation. This includes a reduction of the current standard period of Regulatory Data Protection (RDP) from 8 to 6 years, with the possibility of obtaining 2 additional years when launching in all Member States within 2 years of marketing authorization. Given the controversy regarding this measure’s effectiveness, this research aims to reconstruct and validate its underlying rationale.

METHODS: A Theory of Change approach was used to 1) reconstruct the EC rationale based on a review of EC documentation 2) validate the EC rationale based on a review of currently available evidence.

RESULTS: The Theory of Change is based on 7 key assumptions, of which 3 were validated, 2 could not be validated, and 2 are contradicted by available data. Problem driver: (1) Manufacturer launch and withdrawal decisions drive unequal access to medicines in the EU (validated). Change mechanisms: (2) Not launching within 2 years will lead to an average 15% loss in a product’s gross profit (validated). (3) The incentive will mainly impact higher sales medicines with regulatory protection as their last layer of protection (insufficient data). Outputs: (4) Around 66% of affected medicines will be launched within 2 years (insufficient data). (5) Not launching within 2 years means generic competition will start earlier (validated). Outcomes: (6) 15% increase in the share of EU population with access to new medicines (contradicted, as absence of other problem drivers is assumed). (7) Saving of 444 million for payers (contradicted, as the nature of products which fail to comply is not considered).

CONCLUSIONS: More data is needed to confirm EC assumptions regarding the number of products and manufacturers that are positively affected by the proposal. Assumptions regarding the outcome of the measure are contradicted by currently available evidence.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

HPR221

Topic

Health Policy & Regulatory

Topic Subcategory

Health Disparities & Equity, Public Spending & National Health Expenditures, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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