Legislation 1: HMR Introduction

NHS Healthcare Vs Private Healthcare

NHS

• Provided by the government

• Available to all

• Funded by taxation – National Insurance contributions

Private Healthcare

• Provided by businesses and individual practitioners

• Available to all who pay

• Funded by the patient - Insurance

Who works in primary care?

GPs

Dentists

Community Pharmacists

Optometrists

Who works in secondary care?

Hospitals

Who works in tertiary care?

Specialties e.g. neurosurgery, transplant

When was the NHS established?

5 July 1948

When did the NHS Act happen?

NHS Act 1977

What did the NHS Act 1977 do?

• 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

When did Medicine’s Act pass?

1968

Why did we need the Medicine’s Act?

Until the introduction of the Medicines Act 1968 most medicines were regulated as poisons with no control over the marketing of new medicines.

Committee on Safety of Drugs 1963

• Voluntary agreement by the Ministers of Health to look at the safety of new drugs.

• The Committee on Safety of Drugs consisted of:

  • scientists, physicians, toxicologist, statistician and pharmacists

  • checking for “reasonable safety of a drug’s intended purpose”

• Products already on the market were granted a provisional Licence of Right.

What did the Medicine’s Act 1968 do?

Regulated

• Manufacture

• Distribution

• Importation (limited control on medicines for exports)

Did so by licence and enforced by MHRA (Medicines and Healthcare products Regulatory Agency).

Advised by Medicines Commission

From 14th August 2012

What does the Human Medicines Regulations 2012 do?

• Regulates everything to do with Human Medicines.

• SI due to European legislation

• Replaces much of the Medicines Act and around 200 SI’s.

• Medicines Act still exists.

• The regulations consolidate nearly all existing UK Medicines legislation and simplify the way it is drafted

What does the Human Medicine Regulations 2012 regulate?

• Manufacture

• Distribution

• Importation

• Sale and supply

• Labelling and advertising

• Pharmacovigilance

The Human Medicines Regulations 2012 also deals with:

• Supply of Medicines to the public

• Labelling and Containers

• Sales promotion (advertising)

• Preparation of BP & other books of standards

Enforcement lies with:  

• Secretary of State

• General Pharmaceutical Council (GPhC)

• “Drugs authority” – Local Council

[Registration of Retail Pharmacies still lies with the Medicines Act 1968]

Main aims of HMR

Quality

Safety

Efficacy

….of a medicinal product

Licensing authority

Licensing authority is either or both of the ministers [Secretary of State and the Minister of Health, Social Services and Public Safety].

MHRA – licensing in UK – government agency (London).

Brexit – EU law written into UK law (EU retained Law)

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In relation to a medicinal product, includes anything designed to promote the prescribing supply, sale or use of that product.

Special provisions for pharmacies

Exempts the need for manufacturing licence when extemporaneous dispensing.

Classification of medicinal products

GSL

POM

P

GSL

A medicinal product covered by authorisation that states it should be available on general sale

POM

A medicinal product covered by authorisation that states it should be available only on prescription

P

A 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

Medicinal Product means what?

• 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.

Medicinal purpose is from the MA 1968. What does it mean?

Medicinal Purpose means any one or more of the following:

• (a) treating or preventing disease

• (b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition

• (c) Contraception

• (d) Inducing anaesthesia

• (e) Otherwise preventing or interfering with the normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function in any other way

Who is an appropriate practitioner in relation to a POM?

(a) a doctor;

(b) a dentist;

(c) a supplementary prescriber;

(d) a nurse independent prescriber; and

(e) a pharmacist independent prescriber.

What does the term medical device mean?

The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.