legislation Human medicines regulation Flashcards
(41 cards)
The United Kingdom is divided into three distinct legal jurisdictions
English law in England and Wales;
Northern Ireland law in Northern Ireland;
Scots law in Scotland
What is “Law”?
The regulation of human affairs and human relationships
Complex concepts of:-
Rights
Duties
Rules
Regulations
Authority
Morality
Settling disputes
Dynamism (changing as society develops)
Categories of English law
- Criminal law (Statute law)
Relationship between an individual and the state - Civil law
Relationship between individuals
Tort & breach of duty of care - Administrative law
Part of civil law which deals with supervisory roles courts have in relation to the activities of public bodies - Judicial precedent (Common law)
Tort
Wrongful act for which someone can be sued for damages in a civil law court
Includes such acts as libel, trespass, injury done to someone
whether intentionally or by negligence
examples might include mis-diagnosis, inappropriate prescribing, dispensing error
Judicial precedent
The principles of judicial precedent are such that when a case is decided in higher courts, lower courts have to follow the decision
Judges can manipulate the common law provided without waiting for parliament to enact legislation.
Judges can be subsequently overruled
The courts
Responsibility of courts to determine whether the law has been breached and to settle disputes.
Criminal courts
Civil courts
How does Parliamentary law come into effect?
Green & White Papers
Private Member’s Bill
Act of Parliament
Delegated legislation
Government papers
Green papers
-Consultative documents – what the government might do
White papers
-Firm proposals – what the government will do, given the acceptance of a parliamentary majority
Advantages of delegated legislation
Saving of Parliamentary time
Delegated legislation is enacted by appropriate minister
Greater flexibility
Greater speed of action and implementation in an emergency
Allows greater use
Current UK pharmaceutical legislation
Medicines Act 1968
Misuse of Drugs Act 1971
Poisons Act 1972 and Rules
Heath Act 2006
Pharmacy Order 2010 established the GPhC
Human Medicines Regulations 2012
The Human Medicines (Amendment) Regulations 2013-2019 etc.
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2021
Medicines and Medical Devices Act 2021
Provision of Care
Both NHS and Private
1.Primary Care
GPs
Dentists
Community Pharmacists
Optometrists
2.Secondary Care
Hospitals
3.Tertiary care.
Specialities eg Neurosurgery, Transplant
The National Health Service5th July 1948
The NHS Act established a ‘comprehensive health service to secure the improvement in the physical and mental health of the people . . . and the prevention, diagnosis and treatment of illness’.
Aim to provide healthcare based on need, not the ability to pay
Originally free at the point of delivery
Now charges for some services including prescriptions
The NHS Act 1977 repealed the whole of the 1946 Act.
Human Medicines Regulations: Part 1- General
Special provisions for pharmacies –
Exempts the need for manufacturing licence when extemporaneous dispensing.
Classification of medicinal products
GSL (medicinal product covered by authorisation that states it should be available on general sale).
POM (medicinal product covered by authorisation that states it should be available only on prescription).
P (medicinal product that is not a prescription only medicinal product or a medicinal product on general sale- covered by authorisation that states it is to be available only from a pharmacy).
Definition of Medicinal Product (MP)
Medicinal Product means-
Any substance or combination of substances presented as having properties of preventing or treating disease in human beings, or
Any substance or combination of substances that may be used by or administered to human beings with a view to:-
Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
Making a medical diagnosis
Commission on Human Medicines (CHM).
The Commission on Human Medicines (CHM) advises ministers on the safety, advising on applications for National marketing authorisations
considering further representation against our provisional advice in respect of national applications
advising on the need for, and content of, risk management plans for new medicines
advising on the impact of new safety issues on the balance of risks and benefits of licensed medicines - eg adding warnings, restricting or suspending use of a medicine
advising the licensing authority on changes to legal status of marketing authorisations
efficacy and quality of medicinal products
Advised by expert advisory Groups
minimum of 8 members they are appointed by ministers
proactively give info to ministers and advise them when asked
meet once a month
provides independent expert advice to the regulatory agency the MHRA
parliamentary procure in enacting legislation
- consultation
- consultative documents - green and white papers
- sponsored Bill- initiated by government or private member
- bill drafted into house of commons
- bill passed to house of lords for reading
6.final readings in the house of commons - royal assent
8.statute books
primary legislation
Act of parliament misuse of drugs act 1971
examples of secondary legislation
ORDERS- misuse of drug Act - amendment order 2008
Regulations- Notification of and supply to addict regulations 1997
RULES-misuse of drug at tribunal rules 1974
the national health insurance act 1911
Act gave statutory recognition to dispensing by or under the supervision of a pharmacist
Why did we need the Medicines Act?
Until the introduction of the Medicines Act 1968 most medicines were regulated as poisons with no control over the marketing of new medicines.
what year was the arsenic act
1851
what year was the poisons and pharmacy Act
1908 and 1933
what year was the pharmacy Act
1868
what year was the therapeutics substance Act
1925
