1-2_Legislative_system_BB_2022-23_1_
UK Legislative System and Pharmacy Law
Page 1: Introduction to Law Relating to Pharmacy
Focuses on the UK legislative (legal) system.
Specific emphasis on pharmacy laws in the context of MPharm (Master of Pharmacy).
Page 2: Intended Learning Outcomes
Recognize the UK legislative system relevant to pharmacy laws.
Understand the general legislative background, including:
Medicines Act 1968: Foundation for UK medicine regulation.
Human Medicines Regulations 2012: Sets standards for human medicines.
Veterinary Medicines Regulations 2013: Regulates veterinary medicines.
Appreciate the impact of EU law and directives on UK pharmacy law.
Page 3: Types of UK Law
Primary Legislation: Laws passed by Parliament.
Secondary or 'Delegated' Legislation: Laws made by bodies other than Parliament under the authority of an Act.
Judicial Precedent: Also known as 'case law' which is made by judges through court decisions.
Page 4: Primary Legislation
Enacted primarily through Acts of Parliament that establish general principles.
Key examples include:
Medicines Act 1968: Framework for the regulation of medicines.
Misuse of Drugs Act 1971: Controls the use of certain drugs.
Poisons Act 1972: Regulations surrounding toxic substances.
Page 5: Formal Procedure of Enactment
White Paper: Government's intention to propose legislation.
Green Paper: Discussion document inviting feedback from stakeholders.
Bill: Proposal for new legislation:
Government Bills: Most common type.
Private Member’s Bill: Introduced by an individual MP.
The Bill must be debated and passed in both houses of Parliament.
Page 6: Enactment Process (cont.)
Royal Assent: Formal approval required for a Bill to become an Act.
An Act may take effect immediately or be delayed.
Alterations to an Act can only be made through another Act.
Page 7: Secondary Legislation
Acts typically delegate authority to other bodies to establish detailed rules:
This makes secondary legislation enabling.
It is subsidiary to primary Acts, usually in the form of Statutory Instruments (SI).
Includes Regulations and Orders.
Page 8: Statutory Instruments (SI)
SI addresses detailed workings and are not standalone; they reference the relevant Act.
Can amend or repeal previous SIs.
Page 9: SI (continued)
Initiated by government ministers under powers granted by an Act.
Becomes law after being laid before Parliament for 3 days.
Both Acts and SIs can include Schedules detailing specific provisions.
Page 10: Judicial Precedent
Also referred to as case law or judge-made law.
Represents the legal position based on previous court decisions.
Judges have the authority to create legal precedents when:
There is no existing legislation on a specific issue.
The existing legislation is ambiguous or unclear.