On 25 November 2020, the European Commission launched the Pharmaceutical Strategy for Europe to ensure that patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity, and sustainability of the European Union’s pharmaceutical industry. The Strategy will support patient-centred innovations and accommodate digital and technological change.
The Women’s Brain Project (WBP) is delighted to see that the European Commission recognises that treatments for neurodegenerative diseases are still lacking and we need to stimulate innovation in this area. Moreover, it’s great to see that gender has been highlighted as a critical factor to consider in terms of clinical trials, artificial intelligence and unmet needs.
As an international non-profit organisation studying sex and gender determinants of brain and mental health to achieve precision medicine, we applaud the European Commission for highlighting the following key issues:
- Clinical Trials: The Commission will work to ensure that the new framework supports innovative trial designs. It will support more patient-oriented design, planning and conduct of clinical trials. This includes representative participation of population groups, for example gender and age groups, that are likely to use the medicinal product investigated in the clinical trials to ensure appropriate safety and efficacy.
- Artificial Intelligence: High performance computing and artificial intelligence (AI) can help accelerate the identification of potential active substances for repurposing and reduce the high failure rates. Due care should be taken to avoid any gender, race or other bias in the data produced by artificial intelligence.
- Unmet needs: Treatments for neurodegenerative diseases are still lacking. Furthermore, the lack of treatments for specific population groups such as pregnant and breastfeeding women, and older people also need to be addressed.
- Health data: The Commission will propose a European health data space and establish interoperable data access infrastructure, which will improve exchange, federated access and cross-border analysis of health data in the EU. This will support better healthcare delivery and health research, policymaking and regulation, while protecting individuals’ fundamental rights, notably their rights to privacy and data protection.
- Digital transformation: This is affecting the discovery, development, manufacture, evidence generation, assessment, supply and use of medicines. Among other things, the European Commission proposes to revise the pharmaceutical legislation, to adapt to cutting-edge products, scientific developments (e.g. genomics or personalised medicine) and technological transformation (e.g. data analytics and digital tools) and provide tailored incentives for innovation – 2022.
- Personalised medicine: Digital therapeutics can use app-based platforms to help patients manage chronic diseases such as diabetes, depression and heart conditions, and reduce medication.
Flagship initiatives have also been put forward in the Pharmaceutical Strategy for Europe to address these very important issues.
WBP will closely follow the developments on the Pharmaceutical Strategy for Europe and looks forward to working with the EU institutions to ensure that we reach the best possible outcome for both science and patients.