1-3 Legislative system BB 2022-23(1)

UK Legislative System and Pharmacy Law

  • The UK has a structured legislative system that significantly influences pharmacy law.

  • Key components include statutes, regulations, and directives that govern pharmaceutical practices and safety.

Intended Learning Outcomes

  • Recognise the UK legislative framework underpinning pharmacy law.

  • Understand key legislations relevant to pharmacy:

    • Medicines Act 1968: Establishes the framework for classifying, licensing, and regulating medicines in the UK.

    • Human Medicines Regulations 2012: Consolidates and updates previous regulations regarding the regulation of human medicines.

    • Veterinary Medicines Regulations 2013: Regulates the use of medicines for animals.

  • Appreciate the significance of EU law and directives in shaping pharmacy legislation.

European Union (EU)

  • Established in 1957, the EU plays a critical role in regulating various sectors, including pharmacy.

European Union Law

  • European Commission: Initiates most European legislative proposals.

  • Council of the EU: Holds the authority to make final decisions regarding EU laws.

  • European Parliament: A directly elected body that participates in the legislative process.

  • European Court of Justice: Ensures uniform interpretation of EU law; their decisions are binding on member states, with no right to appeal.

Types of EU Legislation

  • Primary Legislation:

    • Treaties that form the constitutional basis of the EU.

  • Secondary Legislation includes:

    • Regulations: Have direct effect and are binding across all member states.

    • Directives: Set out objectives to be achieved by member states, allowing flexibility in implementation.

    • Decisions: Binding on specific entities or individuals and typically administrative in nature.

  • Harmonisation of laws often occurs through directives, ensuring consistency among member states.

Examples of European Law Affecting Pharmacy

  • Free Movement of Pharmacists:

    • Council Directive 2005/36/EC facilitates the recognition of health professional qualifications across EU nations.

    • This represents a key legal framework supporting the mobility of pharmacists within the EU.

    • GB Regulations:

      • The European Qualifications (Health and Social Care Professions) Regulations 2007 (SI 3101) and its amendments post-Brexit.

    • Schedule 2 refers to the recognition of qualifications for pharmacists and pharmacy technicians in the context of the EEA.

Further Examples of European Law in Pharmacy

  • Regulations surrounding production and distribution of medicinal products:

    • Includes guidelines for homeopathic, traditional herbal medicines, advertising, and labelling practices.

    • Regulations governing wholesale distribution and medicinal product safety.

    • Constraints on production of animal medications and data protection regarding medicinal products.

    • Related legislation includes the Human Medicines (Amendment etc.) (EU Exit) Regulations for 2019 and 2021.