There are various opportunities to contribute to EU law-making as it evolves – from the preparation phase through to proposals for new laws and evaluations of how existing laws are performing.
Stakeholders can contribute to public consultations and various feedback mechanisms throughout the policy cycle. Please find below summaries and links to the consultations EANM has recently replied to.
The European Medicines Agency (EMA) is in the process of revising its Guideline on Radiopharmaceuticals, which was last updated in 2008. With significant advancements and innovations in Radiopharmaceuticals over the past 16 years, it has become essential to modernise this guideline.
This revision aims to: 1) Provide further clarity on issues that have led to non-harmonised interpretations; 2) Address topics that were inadequately covered or detailed in the current guideline; 3) Offer guidance on emerging issues resulting from recent developments and evolving practices.
A consultation process has been taking place open to all the stakeholders who wish to share their input and feedback with the EMA. The EANM has replied to the consultation on the Concept Paper on the revision on the Guideline on Radiopharmaceuticals (EANM reply available here) and on the Concept Paper on the revision of the Guideline on Radiopharmaceuticals based on Monoclonal antibodies (EANM reply available here).
Consultation on the European Radioisotopes Valley Initiative (October 2022)
As part of the SAMIRA Action Plan’s pillar on the security of the supply of medical radioisotopes, the European Commission plans to establish a European Radioisotope Valley Initiative (ERVI), aiming at maintaining Europe’s global leadership role in the supply of medical radioisotopes. To further define this initiative’s objectives and scope, the European Commission launched a targeted consultation over the autumn to gather stakeholders’ positions on the ERVI objectives and the specific issues concerning the supply chain of medical radioisotopes.
The EANM provided feedback, highlighting the crucial need for such an initiative, given the recent large and unexpected outages ultimately impacting patients´ procedures and considering that the demand for radionuclides will only increase in the future.
The EANM pointed out that, for such an initiative to be a success, a holistic approach should be taken:
- Considering the entire supply chain so that the produced radioisotopes are easily available anywhere in Europe at a fair price.
- Ensuring that the EU’s strong tradition in Nuclear Medicine will perpetuate in the next decades by reducing the EU’s reliance on foreign suppliers.
- Focusing on the development of new radioisotopes and new production methods.
In the context of the review of the International Commission for Harmonisation’s (ICH) Guidelines on Analytical Procedures (Analytical Procedures Development and Validation of Analytical Procedures), which opened for public consultation in July 2022, the EANM provided feedback, highlighting the specificities of radiopharmaceuticals in any regulatory framework.
The EANM pointed out that while such guidelines represent a general and commonly accepted basis for the development and validation of analytical methods for most drug substances and products, these guidance documents do not fully address all the specific tests required for the analysis of radiopharmaceuticals and the latter should therefore be excluded of the scope of the ICH analytical procedures guidelines. In this respect, in the past years, the EANM, in cooperation with EDQM, developed a guideline on validating analytical methods for radiopharmaceuticals.
With the publication of an initiative on NCDs, ‘Healthier Together’, the European Commission aimed at supporting European countries in reducing the burden of NCDs. The initiative, focusing on five main areas (including cardiovascular diseases; diabetes; chronic respiratory diseases; mental health and neurological disorders; and health determinants), will provide support for EU countries all along the care pathway by developing guidelines, rolling out innovative approaches, transferring best practices and using EU funding instruments.
The EANM has been involved in the consultation process for the neurological and cardiovascular strands. The main elements of our reply included the following:
- elaborating a European system for data generation and collection on NCDs;
- harmonisation of cardiovascular and neurological data for PET/CT scans;
- harmonisation of proof-of-concept studies for Radiopharmaceuticals.
In the context of the upcoming review of the European Pharmaceutical Legislation (Directive 2001/83 EC), the EANM has provided feedback to the related public consultation, highlighting the current regulatory challenges for radiopharmaceuticals.
Given the recent innovations in nuclear medicine, the nuclear medicine community believes that it is reasonable that the requirements laid out in Directive 2001/83 EC, which is also applicable to radiopharmaceuticals, need to be revised. The challenges posed by implementing this outdated regulatory framework manifest in different ways, but mainly resulting in an increased level of heterogeneity in the interpretation of the Directive among Member States and, ultimately, a negative impact on the availability of radiopharmaceuticals due to an unsure legal basis.
In this respect, the EANM sees the need for the adaption of Directive 2001/83 in the following areas:
- Definition of terms to reflect today’s nuclear medicine and radiopharmacy practices
- Differentiation in regulations between kit-based radiopharmaceuticals preparation and complex radiopharmaceuticals preparation
- Differentiation in regulations considering production settings (commercial vs in-house)
- Evaluation of dedicated guidelines for the in-house preparation of radiopharmaceuticals for non-commercial use within healthcare establishments could be implemented in the revision