Advertising and promoting of medicines

introduction

• Human medicines regulation 2012

• public health by controlling promoting of prescription medicines

• MHRA investigate complicaints and take enforcement action

Prohibition on advertising prescription medicines to the public

• Part 14 HMR2012

• promotion in any media

• no advertising POMs to the public

• prevent patient demand

• applies to any person, not just pharmaceutical companies

• limited exemption

Providing information to the public

• factual, non promotional information on POMs permitted to inform public

• needs to be objective, non sensationalised tone and medically accurate

Compliance with SPC

• only therapeutic indication listed in the SPC

• only to the patient group indicated

• may include statements not included in the SPC

  • must be substantiated and are not inconsistent with SPC info

• no information about planned or ongoing trials

  • likely to be seen as promoting unlicensed indications

Encouraging rational use

• correct and proper use

  • this might include when a medicine should be taken, how much should be taken, the route of administration, by whom it should be taken and special precautions

• must present information which is factualy correct

• do not exaggerate

not misleading

• leading to an erroneous belief

• unrealistic or inappropriate images can be misleading

Providing information to the public

• the following must be included when advertising to the public:

  • name of product

  • how to use

  • reference to the PIL

Adverting to healthcare professionals

• prescription only and OTC medicines

• person qualified to prescribe or supply

  • doctors, dentists nurses, pharmacist etc

advertising to healthcare professional

• the following must be included when advertising to HCPs:

  • licence number

  • legal classification

  • name and address of the business

Compliance and enforcement

MHRA investigates complaints, monitors advertising and

can require changes

• Sanctions include requiring companies to issue

corrections in journals etc.

• Independent Review Panel provides scrutiny of

cases/input to MHRA decisions

self regulation

The control of medicines advertising in the UK is based

on a long-established system of self-regulation.

• The statutory powers of the MHRA, acting on behalf of

Health Ministers, underpin and support this system.

regulatory codes of practice

Prescription Medicines Code of Practice Authority

(PMCPA)

• Proprietary Association of Great Britain (PAGB)

• Health Food Manufacturers’ Association (HFMA)

• Office of Communications (Ofcom)

• Advertising Standards Authority (ASA) and Committees

of Advertising Practice

prescription medicines code of practise authority

Association of the British Pharmaceutical Industry (ABPI)

• Consultation with the British Medical Association (BMA),

the Royal College of Nursing (RCN), the Royal

Pharmaceutical Society (RPS), the Serious Fraud Office,

the Competition and Markets Authority and the MHRA.

• It is a condition of membership of the ABPI to abide by

the Code