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HAI welcomes the opportunity to provide feedback to the evaluation and revision of the general pharmaceutical legislation and appreciates the importance of the initiative taken by the European commission to update and adapt a keystone of the European Health Union.

EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.

EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.

EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.

Health Action International (HAI) welcomes the opportunity to contribute to the ‘Revision of the EU legislation on medicines for children and rare diseases’ and commends the European Commission for the thorough and comprehensive consultation process that is shaping the reform of legislation on this topic.

EFPIA members are committed to ensuring that unmet needs are addressed and that available treatments reach all European patients. Children and rare disease (RD) patients have greatly benefited from the progress achieved through the Paediatric and Orphan Regulations. The Paediatric Regulation is meeting best-case expectations from its impact assessment (IA) conducted in 2004.

The substantial investment in R&D by multiple actors over many years into novel technologies, vaccine, therapeutic and other products now available to address Covid-19 would not have occurred without the robust IP system in the EU and elsewhere. IP protections, particularly patents, has provided the legal framework and incentive for the high risk, high-cost investment underpinning the response to the pandemic.

Health Action International (HAI) welcomes the step taken by the European Commission towards an enhanced use of Compulsory Licenses (CL) in EU territory; such measure will have a positive impact on access to medicines and health technologies, strengthening the ability of governments to fulfill the human right to health beyond crisis or exceptional circumstances.

In its Compulsory Licensing (CL) proposal, the European Commission (EC) posits a new EU-wide CL for crisis response. This harms IP rights and is a dramatic expansion of the ECs role into Member State (MS) remit, where viable CL provisions already exist. CLs are a last resort, all attempts at voluntary licensing having failed.

The European Commission proposal COM(2023)224 and accompanying documents is an overdue step forward towards a more nuanced balanced between innovation and access as it aims to streamline and facilitate the use of Compulsory Licenses.