Introduction to English Law Study Pack Flashcards
When was Thalidomide sold and prescribed?
during the late 1950s
When was Thalidomide sold and prescribed to pregnant women and How did it help them?
In the early 1960s and helped them to sleep and antisemitic to combat morning sickness
It took several years for anyone to realise that thalidomide was?
Teratogenic - disturbs the development of the foetus leading to birth defects
When was The Committee on Safety of Drugs created in the UK?
In 1963
What was the yellow card scheme and when was it introduced?
- It was introduced after the Committee on the Safety of Drugs was created
- a voluntary system for reporting adverse drug reactions (ADRs)
What was the purpose of The Medicines Act 1968?
To control the safety, quality, and efficacy of medicinal products.
When was the Committee on Safety of Medicines (CSM) replaced by and when?
the Commission on Human Medicines (CHM)
in 2005
What is the Commission on Human Medicines?
an advisory, non-department public body which is sponsored by the Department of Health and Social Care and provides advice to ministers on the safety, efficacy and quality of medicines
What is the Human Medicines Regulations 2012 Legislation?
new regulations set out a comprehensive regime for the authorisation of medicinal products for human use and manufacture, import distribution, sale and supply of those products; for their labelling and advertising and for pharmacovigilance
What are the two laws that the English Legal system includes?
statue law
common law
What does Statue Law consist of?
primary and secondary legislation
What is Primary Legislation
Used to describe the main laws passed by the legislative bodies of the UK (including UK parliament)
What is Secondary legislation?
the law created by ministers or other bodies under powers given to them by an Act of Parliament
What is the division of Secondary and Primary legislation?
Primary legislation such as an Act of Parliament can take months to pass through all of the parliamentary processes whereas Secondary legislation such as regulations can be made very quickly
What does parts 10 to 17 and 22 have in common?
they give powers to the Secretary of State to make regulations
part 10 is vague and gives very wide powers
What does the Misuse of Drugs (Amendment) (England Wales and Scotland) Regulations 2014 do?
they were made in response to concerns about the trade-in khat, a herbal stimulant.
the regulations control the import, export, production , supply and possession of khat
What is the first step in creating a new law or changing an existing law on which coloured paper?
green - a consultation document put together by a Government department
Is green paper a statement of policy?
no, it is not but it is supposed to stimulate discussion by putting forwards ideas for future government policy
what is the green paper available through?
the department’s website
who is able to comment on a green paper?
anyone
what is the next step coloured as?
white paper
what does white paper explain?
the Government’s preferred future policy on the subject before it introduces legislation
what does white paper allow the government to do?
to test public opinion and gather feedback before presenting a Bill to Parliament
what does green paper and white paper together make up?
a consultation process before a new piece of legislation is put before Parliament
What does the Parliamentary stage start off with?
the Monarch’s speech
How often is the Monarch’s speech made?
each year at the opening of Parliament and sets out the Government’s propsals for legislation in the coming year
What happens at the stage of the Bill?
the proposed new law is then presented to Parliament
What can the Act of Parliament (statue) do?
can create a new law or change an existing law
What does all of Acts of Parliament make up?
the body of UK statue law
What is Common Law (case law)?
a body of law that has been built up over many years - based on the principle of judicial precedent
What does Judicial precedent mean?
when a decision has been made by a judge sitting in a court, that decision is binding in later cases where the facts are the same/similar - in common law a court bases its decisions on previous court decisions made in similar cases, judges only decide what is always has been not what the law is
what does Common Law cover?
Criminal Law
Civil Law
What are the Other Areas of Law?
Criminal
Civil
Administrative
Professional