PL+E 1: Sources and Types of Law Flashcards
(22 cards)
All pharmacists must abide by the laws that relate to various aspects of…
Opening and running a pharmacy, providing services to patients under NHS community pharmacy contractual framework, all tasks involving medicines
What 3 main areas of law within the British legal system are relevant to pharmacy?
Criminal, civil, administrative
What is the main purpose of criminal law in pharmacy?
To maintain social order and protect community
What happens if criminal law is broken in pharmacy?
Person can be investigated (e.g. by MHRA, GPhC), arrested, and prosecuted under judicial system - in England and Wales you attend magistrates/crown court, jurors listen to case and determine innocent/guilty.
What are the penalties for breaking criminal law in pharmacy?
Fines, imprisonment
What is the main purpose of civil law in pharmacy?
To regulate the rights of citizens or citizens against the state/corporate bodies
How is a civil law case brought about in pharmacy?
Individual makes claim/sues other person in relation to wrongs/harms - clinical negligence like breach of confidentiality, treating without consent
What are the penalties for breaking civil law in pharmacy?
Monetary (fees to pay), damages, considered in county court or high court
How are civil cases proved in pharmacy?
On a balance of probability - must be decision that more than 50% probability defendant is guilty
What are common pharmacy cases dealt with in civil law?
Negligence claims, actions of pharmacist dealt with under civil justice system
What is administrative law + what is it a subsection of?
Part of civil law, ensure there are procedures in place to ensure decision making processes + systems are regulated - all NHS bodies created by administration so must act within laws given to them
How are cases handled in administrative law?
Organisations acting unlawfully according to stipulated law will be dealt with by tribunals and inquiries
How are ideas turned into white papers in 3 steps?
- Recognition of problem/need for change
- Policy development to examine risks + benefits of potential actions
a. Ideas formally consulted on by relevant groups
b. Green paper (discussion document)
c. White paper (objectives and strategic directions, often published) - White papers may lead to legislative changes, must be brought to parliament first
How are white papers turned into bills?
Once policies are agreed, a bill is drafted - this is passed to parliament to be considered (will have to go through both House of Commons and House of Lords)
How are bills turned into laws in 5 steps?
- First reading
- Second reading
- Committee stage - in detail line by line consideration, MPs determine changes needed
- Report stage - changes discussed
- Third reading
(both houses must then agree on stages before it becomes a law, need royal assent first)
What is primary legislation?
Legal framework outlining subject area
What is secondary legislation?
From primary, more detailed legal guidance may arise - regulations, directions, orders, codes
What is case law?
A legal position is taken based on cases/previous decisions made in court in similar situations
What changes happened in UK law after BREXIT?
EU withdrawal Act 2018, laws from EU legislation remained in place until after BREXIT but parliaments gained power to change their laws
What are the 6 core roles of the GPhC to regulate law in pharmacy?
Establish and maintain register of pharmacists, pharmacy technicians and pharmacy premises; set and promote standards for safe and effective running of registered pharmacies; set requirements to which registrants must demonstrate; promote safe and effective practise of pharmacy by registrants; set standards and requirements for education, training and acquisition of experience; ensure continued FTP of registrants
Who makes up the GPhC?
Chair, 13 members of council (7 registrants, 7 lay members)
What are 4 key legislations to remember?
Medicines Act 1968, Human Medicines Regulations 2012, Misuse of Drugs Act 1971, Medicines and Medical Devices Act 2021 (after BREXIT)
