PGEU (Pharmaceutical Group of the European Union)

European community pharmacists support the European Commission's proposal for the reform of the EU pharmaceutical legislation. PGEU believes the proposal includes important provisions to improve the supply of medicines to meet patients needs, regardless of where they live in the Union.

PGEU welcomes the opportunity to provide input in the context of the European Commission roadmap/inception impact assessment on the Evaluation and revision of the general pharmaceutical legislation. Our contribution addresses the issues that have a direct impact on community pharmacy, namely security of supply of medicines including shortages, medicines accessibility, and environmental sustainability.

The Pharmaceutical Group of the European Union (PGEU), the organization representing community pharmacists in 32 European countries, welcomes the European Commission’s Proposal for an EU Regulation on Artificial Intelligence (AI) to establish a legal framework on AI Systems. Please find the full PGEU feedback to the European Commission's Proposal attached hereto.

The Pharmaceutical Group of the European Union (PGEU), the organization representing community pharmacists in 32 European countries, welcomes the European Commission’s Roadmap aimed at addressing a number of ethical and legal issues raised by Artificial Intelligence (AI).

PGEU welcomes the initiative for a Council Recommendation on cardiovascular health checks. The Recommendation should recognise community pharmacists as providers of cardiovascular checks, actively contributing to providing these type of services to the population in a cost-benefit way. The call for evidence identifies missed opportunities to detect hypertension, high glucose and high cholesterol.

(2/2) Third, Articles 17-23 should translate data minimisation, purpose limitation, confidentiality and security into concrete technical safeguards. Personal data and metadata processed by the central platform should be limited to what is strictly necessary; access should be traceable and subject to clear authorisation, and technical design must not enable re-profiling, excessive access requests or the treatment of…

(1/2) PGEU welcomes the objective of establishing a secure, interoperable and trustworthy HealthData@EU infrastructure for the secondary use of electronic health data. The technical framework should, however, operationalise the highest standards of data protection, confidentiality and professional ethics, while avoiding unnecessary burdens on healthcare professionals and community pharmacies.

PGEU welcomes the aim of this draft Implementing Regulation to make dataset catalogues for secondary use standardised and interoperable. High-quality metadata can support public-interest research, public health, pharmacovigilance and evidence on medicines use. However, the catalogue must be a transparency tool, not a gateway to commercial exploitation of sensitive health data.

Part 2. Most community pharmacies are SMEs and costs will likely be passed on by vendors. The principle of proportionality should explicitly include an assessment of negative net impact in highly digitalised countries.

Part 1 PGEU supports MyHealth@EU as the common infrastructure for cross-border primary use of electronic health data. For community pharmacists, it will deliver value only if it makes cross-border ePrescriptions safer, faster and legally clear at the pharmacy counter, while preserving confidentiality and continuity of supply.

PGEU welcomes the aim of the draft Implementing Regulation to make cross-border identification and authentication reliable for personal electronic health data. For community pharmacies, these rules matter at the point of care: pharmacists must identify the patient, prove professional authorisation for access to his/her data and limit such access only to the data needed for safe dispensing and care.