9th EUFEPS Talks
We want to invite you to the 9th EUFEPS Talks on November 14, 2022 at 4 pm CET.
The EUFEPS Regulatory Science Network will give a talk with the title: "One substance, one assessment".
Chemicals are developed, produced and used in many contexts, e.g., in medicines, food, biocides, batteries or cosmetics. On 14 October 2020 the European Commission (EC) has published the EU Chemical Strategy for Sustainability. This strategy follows key ambitions of the European Green Deal and aims to reconcile the societal value of chemicals in terms of health (e.g., protection from hazardous chemicals, availability of essential chemicals for pharmaceutical and other critical health products), innovation (e.g., production and use of safe and sustainable chemicals) and planetary boundaries (e.g., EU zero pollution ambition).
With this strategy the EC aims to work on various ambitions, ranging from strengthening the EU’s open strategic autonomy, or protecting consumers, vulnerable groups and workers from the most harmful chemicals, to simplifying and consolidating the myriad of legal frameworks that are in place for chemicals. Regarding the latter, the EC is working on developing a ‘One substance, one assessment’ approach to make assessment processes simpler, more transparent, more consistent and predictable.
At first glance, these plans look attractive, for various reasons. But they also pose many challenges, particularly to the pharmaceutical space. Just to mention a few:
- Pharmaceutical products are regulated within a certain medical context, i.e. the benefit-risk of a product, including various active ingredients and excipients, may vary across indication for use, medical need, etc. How will ‘One substance, one assessment’ affect this approach?
- The ‘One substance, one assessment’ may result in banning or restricting the use of a chemical for use in food or cosmetics. What does this mean when the use of the same chemical is essential, and very difficult to replace, for pharmaceutical use?
- Pharmaceutical development, production and marketing are very global. What does ‘One substance, one assessment’ mean for products from the UK or US, where the chemical assessment has resulted in a different outcome compared to the EU, i.e. UK regulators have no plans to ban TiO2, as an example, because they feel the evidence to do so is lacking.
For sure ‘One substance, one assessment’ has many regulatory, scientific and policy dimensions. In this EUFEPS Talk we want to address them, discuss them openly and to reflect on how pharmaceutical scientists can contribute to balanced and sustainable solutions. At the end of the day, patients should benefit from these policy changes.
- Welcome by Prof Maria Blanco Prieto, Chair of EUFEPS Talks
- Introduction to the theme, Prof Bert Leufkens, Chair of EUFEPS Regulatory Science Network
- One substance, one assessment, where are we going?, dr Kirsty Reid, Director Science Policy, European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Conversation with the audience, moderated by Prof Hubert Leufkens
- Closing by Prof María Blanco Prieto
A registration is needed for this event. Please use the following link: https://us06web.zoom.us/meeting/register/tZUoceqvpzIsGtV0SyQ4xuEVbbnVYAK474yL. After the regristration you will receive an E-Mail with the log-in details.