An introduction to Law: Why is Law Important to Pharmacists?

What are the required reference texts for the Introduction to English Law study pack?

This study pack and Dale and Appelbe's Pharmacy and Medicines Law (13th Edition).

What is the purpose of studying medicines legislation and ethics as a future pharmacist?

To provide safe and effective care, protect registration by working within legal/ethical boundaries, and understand the framework of the profession.

What does Dale and Appelbe's Pharmacy and Medicines Law contain?

A full list of the literally hundreds of laws that directly affect pharmacy and medicines.

Which two pieces of legislation frequently affect practice as both a student and pharmacist, requiring in-depth knowledge?

The Human Medicines Regulations 2012 and the Misuse of Drugs Act 1971.

Where was the first known drug standard found?

The Salerno Medical Edict of 1240 issued by Frederick II of Sicily.

What was one of the earliest pieces of British medicines regulation, under which pharmacy premises inspection began?

The Apothecaries Wares Drugs and Stuffs Act 1540 (during Henry VIII's reign).

How did medicines legislation develop before World War II?

In a piecemeal, unplanned manner across several different statutes.

What prompted modern twentieth-century medicines regulation?

A series of drug-related incidents, most notably the Thalidomide disaster.

What amendment followed an incident in the USA where over 100 people died from a sulphanilamide elixir prepared with diethylene glycol?

The 1938 amendment to the Federal Food, Drug and Cosmetic Act ensuring evidence of a medicine's safety.

What was thalidomide chiefly prescribed for in the late 1950s and early 1960s?

To pregnant women as an aid to sleep and as an antiemetic to combat morning sickness.

What does teratogenic mean?

Disturbing the development of the foetus leading to birth defects.

What severe malformity did thalidomide cause in approximately 12,000 children born between 1956 and 1962?

Phocomelia.

What committee was created in the UK in 1963 following the thalidomide outcry, leading to the yellow card scheme?

The Committee on Safety of Drugs.

What is the Yellow Card Scheme used for?

A voluntary system for reporting adverse drug reactions (ADRs), now reported online at yellowcard.mhra.gov.uk.

What was the primary purpose of the Medicines Act 1968?

To control the safety, quality, and efficacy of medicinal products through a system of licences and certificates.

Who did the Medicines Act 1968 apply to after the 2006 Veterinary Medicines Regulations?

Only medicinal products for human use.

What is the role of the Commission on Human Medicines (CHM)?

An advisory non-departmental public body sponsored by the DHSC that provides advice to ministers on the safety, efficacy, and quality of medicines.

What is the role of the Committee for Medicinal Products for Human Use (CHMP)?

The EMA's committee responsible for human medicines, playing a vital role in their authorisation.

What is the European Medicines Agency (EMA)?

An agency formed in 1992 to protect and promote human and animal health by evaluating and monitoring medicines within the EU/EEA (relocated from London to Amsterdam after Brexit).

What are Summary of Product Characteristics (SmPCs)?

Key components of marketing authorisations found at www.medicines.org.uk.

What is the role of the MHRA (Medicines and Healthcare products Regulatory Agency)?

An executive agency sponsored by the DHSC responsible for regulating medicines, medical devices, and blood components for transfusion in the UK.

What does the Medicines Act 1968 govern?

The control of medicines for human use, including the manufacture and supply of medicines and medicated animal feeding stuffs.

What does the Human Medicines Regulations 2012 set out?

A comprehensive regime for the authorisation, manufacture, import, distribution, sale, supply, labelling, advertising, and pharmacovigilance of human medicinal products.

Why does "British law" as such not exist?

Because health law has been devolved to Scottish and Welsh parliaments, and Scotland has its own separate legal system.

Who is the professional body and regulator for pharmacy in Northern Ireland?

The Pharmaceutical Society of Northern Ireland (PSNI).

What are the two main components of statute law?

Primary legislation and secondary legislation.

What is primary legislation?

Main laws passed by legislative bodies, such as an Act of Parliament (e.g., Medicines Act 1968, Misuse of Drugs Act 1971).

What is parliamentary sovereignty?

The supreme legal authority of Parliament to create or end any law, meaning courts cannot overturn an Act of Parliament.

What is secondary legislation?

Law created by ministers or other bodies under powers given by an Act of Parliament, collectively known as Statutory Instruments (regulations or orders).

What is the advantage of secondary legislation over primary legislation?

It offers great flexibility and can be made very quickly compared to passing an Act of Parliament.

What is a green paper?

A government department consultation document put together to stimulate discussion and put forward ideas for future government policy.

What is a white paper?

A document explaining the Government's preferred future policy before introducing a Bill to Parliament.

What is a Bill?

A proposed new law presented to Parliament that passes through several stages before becoming an Act of Parliament.

What is common law (case law)?

A body of law built up over many years based on judicial precedent, where courts base decisions on previous court rulings in similar cases.

What are the four headings under which legal matters are categorized in the course?

Criminal law, Civil law, Administrative law, and Professional law.

What are the two components that make up most crimes?

The criminal act (actus reus) and criminal intent (mens rea).

What are strict (or absolute) liability offences?

Offences where intent is not important and does not need to be proven by the prosecution (e.g., speeding).

Who enforces criminal law?

The state, typically via the police or agencies like the MHRA, and prosecuted via the Crown Prosecution Service (CPS).

What two criteria must the CPS be satisfied with before prosecuting?

That there is sufficient evidence (reasonable chance of winning) and it is in the public interest.

What is the standard of proof in a criminal case?

Beyond reasonable doubt.

What are the purposes of sanctions in criminal law?

To punish offenders, prevent re-offending, deter others, and rehabilitate offenders.

What is the purpose of civil law?

To regulate human relationships, protect individual rights, and provide compensation when rights are infringed.

Who initiates a civil law action?

An individual or corporate body (the Claimant) suing another person or body (the Defendant).

What is the standard of proof in a civil case?

On the balance of probabilities.

What is a tort?

A civil wrong, with negligence being the most common tort.

What established the modern concept of duty of care in negligence?

The House of Lords case Donoghue v Stevenson (1932) ("my neighbour" principle).

What four elements must exist for a claim of negligence to succeed?

1. Duty of care owed, 2. Breach of that duty, 3. Loss or injury suffered as a result, 4. Quantification of damages.

What was established by the Bolam test (1957) in clinical negligence?

A doctor/professional is not negligent if they acted in accordance with a practice accepted as proper by a responsible body of medical professionals.

What did the case Dwyer v Roderick, Jackson and Cross Chemists (1982) establish regarding pharmacists?

Pharmacists and prescribers owe patients a duty of care independently, and it is not enough for a pharmacist to blindly follow incorrect prescriber instructions.

What is administrative law?

Part of civil law that creates, regulates, and sets responsibilities for public bodies like NHS Authorities and Trusts.

What is professional law?

Law that gives regulatory bodies (such as the GPhC via the Pharmacy Order 2010) powers to register and discipline health professionals.

What percentage of open Fitness to Practise cases heard by the GPhC relate to online services?

More than 30%.

Where are summary/less serious criminal cases initially heard in England?

Magistrates' Court.

Where are more serious criminal cases tried?

Crown Court in front of a jury.

Where are civil cases initially heard?

County Court or Family Court.

What did the European Union (Withdrawal) Act 2018 achieve?

Repealed the European Communities Act 1972 and ensured EU-derived domestic legislation continued to have effect after exit day.

What did the Medicines and Medical Devices Act 2021 establish in England?

A new Patient Safety Commissioner and allowed amendments to the Human Medicines Regulations 2012 post-Brexit.

What is the European Convention on Human Rights (ECHR)?

An international human rights treaty signed by the UK in 1950, formally incorporated into UK law via the Human Rights Act 1998.

Which ECHR Article protects the right to a fair trial, relevant to GPhC fitness to practise delays?

Article 6.

Which ECHR Article protects the right to respect for private and family life?

Article 8.

Which ECHR Article protects freedom of thought, conscience, and religion (e.g., refusing emergency contraception)?

Article 9.

Which ECHR Article covers freedom of expression (e.g., social media posts)?

Article 10.

How is ethics defined?

"The science of morals," forming the basis of proper professional conduct (such as the GPhC's Standards for Pharmacy Professionals).

What are the four main ethical principles described by Beauchamp and Childress (2001)?

Beneficence, Non-maleficence, Respect for autonomy, and Justice.

How does the Royal Pharmaceutical Society define professional judgment?

The use of accumulated knowledge and experience to make an informed decision, taking into account law, ethical considerations, and surrounding circumstances.

What does the GPhC publication 'In practice: Guidance on religion, personal values and beliefs' (2017) support?

Pharmacy professionals in making good decisions and providing person-centred care within the legal framework when personal beliefs conflict with services.