PL&E 1 - sources and types of law

define a law

a statute or act passed by the UK parliaments

give the 3 main areas of the British legal system relevant to pharmacy

criminal, civil, administrative

outline the role of criminal law

if broken, person/s is investigated, arrested, and if found guilty will be prosecuted under judicial system

jurors listen to facts and determine whether a person is innocent or guilty in court

penalties include fines or imprisonment

what is a key belief in criminal law?

presumed innocent until proven guilty beyond reasonable doubt

outline the role of civil law

regulates rights between citizens or citizens against the state or coporate bodies

individual makes claim or sues the other person in relation to wrongs or harm

penalties based on severity of harm to patient

cases considered in county courts or high court

outline the role of administrative law

part of civil law - supervisory role related to policies or guidelines, courts exercise in relation to activities of public bodies

ensures procedures are in place to ensure decision making processes and systems are regulated in right way

operational rather than clinical side of pharmacy

give examples of when criminal, civil and administrative law would involve pharmacy

criminal - prosecution after failing to supervise sale of prescription only medicines

civil - fitness to practice proceedings eg, patient complaining about harm caused by care provided to them

administrative - breaching NHS pharmaceutical services contract such as not being open from 9am-6pm

describe how ideas are converted to laws

1. recognition of problem or need for change

2. policies developed that evaluate risks and benefits of potential actions to put new regulation in place

3. white paper may lead to legislative changes - must pass through parliament to be approved and become a law

what are white and green papers?

green paper - discussion document where regulations have been granted and discussed

white paper - after green paper, contains objectives and strategic directions on a policy

what is primary legislation?

acts of parliament - legal frameworks outlining a subject

what is secondary legislation?

more detailed guidance arising from primary legislation - regulations, directions, orders, codes - linked to specific topics within the primary legislation

what is ‘case’ (common) law?

a legal position based on cases or previous decisions made in court in similar situations - what has previously been applied and interpreted based on the law

what changes to UK law relevant to medicines were made due to BREXIT?

parliament passed the Medicines and Medical Devices Act in 2021 to enable changes to be made to the Humans Medicines Regulations 2012

act meant that the secretary of state has far more powers to amend existing regulatory framework regarding human and veterinary medicines and medical devices in the UK

how was the General Pharmaceutical Council (GPhC) created?

by Pharmacy Order 2010

what is the GPhC?

an independent regulator for pharmacists, pharmacy technicians and pharmacy premises

who is the GPhC made up of?

a Chair and 13 members of council - 7 registrants (pharmacists and technicians) and 7 lay members (voice of public/patients)

outline some key roles of the GPhC

establish and maintain a register of pharmacists, pharmacy technicians and pharmacy premises

set and promote standards for safe and effective running of pharmacy at registered pharmacies

set requirements which registrants must demonstrate

set standards/requirements for education, training and acquisition of experience

state the 9 standards for pharmacy professionals

1. person-centred care

2. partnership working

3. effective communicator

4. professional knowledge and skills

5. professional judgement

6. professional behaviour

7. confidentiality and privacy

8. speaking up about concerns

9. leadership