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Forum, as a Slovenian R&D pharmaceutical industry association, hereby expresses its support of the European Commission's effort to build a regulatory framework which will ensure availability of innovative, effective and safe medicines throughout the whole European union and that all needs of European patients will be adequately addressed.

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.

FarmaForum, the Slovenian innovative pharmaceutical industry association recognizes the need for comprehensive regulations and standards and welcomes the European Commission legislative initiative aimed at modernising the pharmaceutical legislation.

FarmaForum, the Slovenian innovative pharmaceutical industry association recognizes the need for comprehensive regulations and standards and welcomes the European Commission legislative initiative aimed at modernising the pharmaceutical legislation.

Forum’s views on the proposed European Health Data Space (EHDS) Forum, the Slovenian innovative pharmaceutical association, which represents 21 global research companies, supports the Commission's efforts to generate a legal environment providing for a wide-ranging use, re-use and exchange of health data, acknowledging the value of such data and promoting the harmonization of digital standards, both at the EU and at…

EFPIA welcomes the proposal to create sectoral and horizontal legislative frameworks to unlock the value of data, support the use, re-use and exchange of health data at the EU level and ensure coherence between the operation of the different legislations contributing to the functioning of the Data Space.

The legislative proposal on a European Health Data Space (EHDS) and respective horizontal proposals provide an unprecedented opportunity to shape the future health data and digital ecosystem. Digital transformation has the potential to increase the innovation and productivity of the EU economy and ensure that Europe remains an innovator and world leader in the development and manufacture of medicines, supporting…

In Forum, the Slovenian innovative pharmaceutical association, which represents 22 global research companies, we are aware, that to date, the Paediatric and Orphan Regulations have provided immense benefits for children and patients with rare diseases (RD) in Slovenia. We would welcome Commission’s effort to maintain the legislative framework which would ensure possibilities to treat DS also in the future.

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.

Forum of International Research and Development Pharmaceutical Companies, EIG (FarmaForum), as a Slovenian innovative pharma industry association, expresses its concern regarding the European Commission's (EC) proposal of the new compulsory licensing legislation. The EC's proposal introduces a new right to issue compulsory licenses throughout the EU, which the EC would activate in a "crisis" situation.

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.