1) Sources and Types of Law Flashcards

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1
Q

What are the main divisions of law?

A
  • Statute law

- Civil law

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2
Q

What is Statute law?

A

A law that’s come about by going

through Parliament.

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3
Q

What are the three types of statute law?

A
  • criminal law
  • administrative law
  • professional law
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4
Q

Explain criminal law?

A
  • Concerned with the relationship between individual and the state.
  • There will be an agency (the police) whose task it is to prevent and investigate
    and detect crime and they will be prosecuting the offenders in a medium, so the courts.
  • There are methods by which to convict defendants as well, so the punishment, which may be through sending them to jail.
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5
Q

Examples of some aspects of criminal law do have a direct bearing on pharmacy practice.

A

Requirement of prescription only medicines, they can only be sold, supplied in
accordance with a prescription given by a prescriber. Now, violation of this requirement amounts to a
criminal offence.

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6
Q

Explain administrative law?

A
  • regulates the activities of public bodies e.g the NHS. So where the NHS has a contract with a community pharmacy, the administrative law will be regulating those activities.
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7
Q

Explain professional law?

A
  • Underpins the powers of professional regulatory
    bodies. So in the world of pharmacy, that’s the General Pharmaceutical Council.
  • This is the law
    that underpins the power to discipline professionals.
  • So powers are granted to regulators through statutes.
    The Pharmacy Order of 2010 and its associated rules of those that applied by the General Pharmaceutical
    Council. Now, for health professionals, there’s a general idea that we have an expected standard of care. Now
    this is used by professional tribunals to judge whether a professional is guilty of misconduct.
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8
Q

What is civil law?

A
  • Concerned with relationships between individuals and relates
    to the conduct of human relationship
  • Recognises individual and collective civil rights, which regulates relationships between individuals
  • Protects and enforces these rights by allowing individual
    members of society who feel that one of their rights have been infringed to sue the other individual who is believed to have infringed that right.
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9
Q

What is the major difference between criminal law and civil law?

A
  • The state takes no active part on behalf of individual members of society in civil law actions and it does have a direct involvement in the development of the laws which embody the individual civil rights
  • Also provides the
    methods in the system, so the judges and the courts, et cetera, where individuals can enforce their specific
    rights.
  • It’s important to remember the same set of facts can give rise to both criminal and civil actions.
    -For example, a pharmacist employer who fails to maintain the set of steps which results in an injury to an
    employee may be sued in the civil court by the employee and prosecuted in the criminal court for failing to
    ensure the health and safety and welfare of their employees.
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10
Q

So where do all these laws come from? So there’s four main sources of law:

A
  • primary legislation
  • secondary legislation
  • judicial precedent
  • European Union Law
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11
Q

What is the legislation?

A
  • Each law has a foundation of some kind. In the UK, the rules in the legal system have their foundation in acts performed by Parliament, and they’re written down as a matter of public record. They’re known as the legislation.
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12
Q

Primary legislation?

A
  • Primary legislation is essentially what we

know as Acts of Parliaments, which are created through a formal procedure.

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13
Q

What three elements is Parliament comprised of?

A
  1. The first one is the House of Commons. That’s an elected body of individuals, and the political party with the most seats forms the government. As the name suggests, the role of the government
    is to govern the country, a role it achieves through a large number of government departments, each
    headed by a government minister. The government has the greatest influence over lawmaking or
    legislative process.
  2. The House of Lords, the members of this house have not been elected. They’re either hereditary, which nowadays is very few, or they’ve been appointed. Now, the role of the peers, which is a term that’s used, is to participate in the government and to contribute to the lawmaking work of the
    Commons. They participate in debates and in committees.
  3. And the last elements of Parliament is the monarch, so the Queen. And the role of the monarch in lawmaking is now purely ceremonial. The Queen will open up each parliamentary session, the formal state opening of the Parliament. As part of the ceremony, she will make a speech, so that’s known as
    the Queen’s speech. And that details the legislation Parliament intends to enact during the following
    session. The speech is written by the Prime Minister’s Office and the Queen has no control over its content.
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14
Q

How does legislation come about?

A
  • As proposals from cabinet ministers, either on a
    suggestion from government advisors or result of a commitment to make new laws in an election manifesto.
  • What can happen is a green paper is published by a government department and it sets out the government’s views on an issue and asks for public comment.
  • The next step is a white paper is produced based on the comments from the green paper consultations. The white paper puts forward firm
    proposal, but it does leave room for minor changes.
  • If agreement is reached, the proposals are drafted
    into a document called a bill, and they begin their formal passage through Parliament. Now, in the House
    of Commons, the bill will go through five stages.
    1. The first stage, which is the first reading. That’s a formality, generally introducing that the bill is there
    and setting a date for a second reading.
    Now, the second reading, the minister responsible for the instruction of the bill will formally propose its
    adoption.
    2. Then there’ll be a full debate on the merits of the bill and a vote by all MPs present.
    3. The third stage, which is the most crucial, the committee stage, is the most important stage. The bill is
    considered word-for-word, clause by clause by a committee of about 25 to 45 MPs. Any significant
    amendments required can be proposed and adopted at this stage.
    4. Then we’ve got the fourth stage, the report stage. The committee report its finding to the full House of
    Commons. A debate will take place and further amendments can be suggested, and a vote will be taken
    on the merits of the bill.
    5. In the fifth stage, which is the third reading, a generally short debate takes place, but generally only a
    few significant amendments will be introduced.
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15
Q

Now, the passage of a bill through any stage can take a considerable amount of time or it can be quite
rapid.

A

For example, we take the medicines bill, which is now known as the Medicines Act 1968. Well, the
first reading, that took five minutes, so introducing it took five minutes. The second reading took five and
a half hours. The committee stage, the most crucial stage, had to take place over 20 meetings on an
average of 2.5 hours per meeting. So that was a considerably lengthy process. The reporting stage took
about two and a half hours. And the third reading took one minute. So it’s very variable as to how quick
the process is. And then after it’s gone through the House of Commons, it has to go through the same
five stages in the House of Lords. The House of Lords, they can introduce significant amendments, but
they can’t delay any non-financial bill for more than one year. Again, it can take varying amounts of time.
So again, concerning the medicines bill, we’ve got one minute for the first reading, one and a half hours
for the second reading, two and a half hours for the committee stage. The reporting stage took about two
hours. And third reading took, again, one minute. Then it has to go to the monarch. Once it’s received
royal assent, then it can become an act of Parliament. So the medicine bill was given the royal assent on
the 25th of October, 1968, hence why it’s called Medicines Act 1968.

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16
Q

Why is primary legislation usually enacted?

A

To introduce a new scheme of laws for a particular area.

17
Q

Can primary legislation be repealed, revoked, or amended or even replace early legislation deemed to be out of date or otherwise in need of reform?

A

Yes

18
Q

Secondary legislation?

A
  • So most acts of Parliament delegate powers to other bodies to make detailed rules to complete the whole schedule of the programme of the law, which the minister will propose, intended to introduce. Now, those rules are known as secondary or
    delegated legislation.
19
Q

What is the most major type of secondary legislation?

A

The statutory instrument. An
example in pharmacy related is a statutory instrument — is the Misuse of Drugs Regulations in 1985.
And that was made by the Home Secretary under certain sections of the Misuse of Drugs Act 1971.

20
Q

Can a statutory instrument be repealed or amended?

A

i think so?

21
Q

What does the process of enacting secondary legislation depends on?

A

Its importance
and urgency. The most important secondary legislation will be subject to substantial debate and
vote, whilst the least important legislation doesn’t need to even be laid before the Parliament at all.

22
Q

What is it known as when the courts and judges have a formal role in formulating
law through the judicial precedent process?

A

Case law, common law, judge law

23
Q

What is the difference between legislation and case law?

A

Legislation is described as a body of rules which
has gone through that process of going through Parliament, whilst the latter, so a judicial precedent,
is a statement of legal position in a particular case or situation based on decisions of previous courts
in similar situations or cases, so something that we seen really enacted on the law-type dramas.

24
Q

What two situations do judges put law into?

A

Mainly where there’s no legislation on a

particular issue or where there is legislation and the meaning is unclear.

25
Q

Background on European Union Law?

A
  • UK joined the EU in 1973
  • After that point, almost all law relevant to medicine was actually derived by the EU. Therefore, Europe has been the highest legal authority for
    such laws in the UK.
  • The UK was part of the European Union (EU) between 1973-2020.
  • Between that time The UK was required to the laws of the EU across the UK (harmonisation).
  • Following the announcement of the UK’s withdrawal from the EU the UK Parliament passed the EU withdrawal Act 2018. This states that any law derived from EU legislation will remain in place until after Brexit but that the UK, Scottish and Welsh Parliaments have power to change laws.
  • In particular, Parliament passed the Medicines and Medical Devices Act 2021 to enable changes to be made to the Human Medicines Regulations 2012. This bill received Royal Assent on 11th Feb 2021 and became law. The Secretary of State now has far more powers to amend existing regulatory framework regarding human and veterinary medicines, and medical devices in the UK. The Act also established a new Commissioner for Patient Safety. Significant changes to pharmacy and medicines law are likely to made in the future. Keep an eye on potential changes, for example around ‘hub and spoke’ dispensing models, a UK medicines verification system, and regulation related to artificial intelligence.
26
Q

What are other examples of public bodies in administrative law?

A

Include CCGs, which the clinical commissioning groups. Other examples are local authorities and educational authorities

27
Q

How were the creation of these public bodies allowed?

A

Through an enabling act of Parliament, so that had to happen first before those bodies came into being.

28
Q

What do regulations

made under the act come with?

A

Statute duties on that public body eg. managing budgets, the employment of staff, and entering into contracts

29
Q

What does administrative law apply for?

A

Administrative law is the law that applies if someone
believes that they’ve been wronged by a public body, exceeding their statutory powers, then they can apply
to the administrative court for a judicial review.

30
Q

What is a judicial review?

A

When the court determines whether the public body acted fairly, reasonably, and within its statutory powers. It doesn’t review the factual basis on
which the decision was made, but it looks at the three criteria.

31
Q

What are the three criteria of the judicial review?

A
  • One, was the decision taken lawful or not. So therefore, was it within the powers of that public body to make
    that decision?
  • The second criteria is, was it reasonable and a rational decision? So, had the body considered all the relevant
    facts and ignored those that weren’t relevant?
  • Lastly, was the decisions based on the correct procedures laid down? So that would be almost like a check
    just to see if they followed their own procedures.
32
Q

What do administrative law consist of?

A

Statutes, acts, regulations, orders and directions

33
Q

Who are directions made by and what do they consist of?

A
  • Senior civil servants under the authority of the relevant minister. And it consists of policy statements
    and guidelines
  • Initially, the public authority itself usually enforces the law. So, for example, the enforcement
    of the NHS contract is by the NHS commissioning board. Sanctions are administrative; for example fines and
    it can include the loss of contract.
34
Q

What does civil law allow?

A
  • Derived from the notion of
    duties and responsibilities owed between civil citizens, so members of society.
  • It also allows aggrieved parties to sue for compensation from another citizen who’s alleged to have wronged him. - - Typical cases, civil cases in
    healthcare include clinical negligence, breach of confidentiality, and treating without consent.
35
Q

Clinical negligence?

A

Claimant makes an allegation that another person, the defendant, has caused
them damage or injury. Now the claimant has to prove, on the balance of probabilities, that the health
professional owed them a duty of care. They also need to prove that the duty had been breached, and also
that the breach caused injury

36
Q

Essence of negligence?

A

Now the essence of negligence, is that there is on part of the defendant, a legal
duty of care which they failed to meet, and as a result the plaintiff has suffered damage.

37
Q

What does duty of care mean?

A
  • Duty of care
    means that a health care professional must take reasonable care to avoid acts or missions which they can
    reasonably foresee would be likely to injure their neighbour, or the person that obviously they are treating. So
    basically, it represents a special relationship between pharmacist and their customers. Where the customers
    are reliant upon the skill or knowledge of the pharmacist. Now the law expects that the pharmacist should be
    exercising the degree of competence that the average member with the profession is required to possess.
    And that’s otherwise knowns as the Bolam principle.
38
Q

What is a typical example where negligence can come into play,
or can be seen in practice?

A

Dispensing errors, and they can happen quite frequently. Now most errors
relate to the wrong medicine, and the wrong strength of medicine.