Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which are applicable laws regarding advertising of medicines and medical devices in the UK?

1. Medicinal Products

Primary Legislation

Human Medicines Regulations 2012/1916: This is the main statute regulating the advertising and promotion of medicinal products in the UK.

Guidance

MHRA Blue Guide: Provides detailed guidance on advertising and promotion of medicines, interpreting the Human Medicines Regulations for compliance.

2. Medical Devices

Primary Legislation

Medicines and Medical Devices Act 2021 and Medical Devices Regulations 2002: Currently, these do not explicitly regulate advertising but prohibit marketing of non-conforming devices.

Future Legislation

Expected Regulations in 2025: Will likely include provisions for claims made about medical devices, aligning with the EU Medical Devices Regulations (2017/745/EU and 2017/746/EU).

Northern Ireland Specific

EU Regulations: EU Medical Devices Regulations, EU MDR 2017/745 apply in Northern Ireland due to the Northern Ireland Protocol.

3. General Advertising Law

• Consumer Protection from Unfair Trading Regulations 2008 (CPRs): Regulates B2C advertising, including medicines.
• Business Protection from Misleading Marketing Regulations 2008 (BPRs): Regulates B2B advertising, including comparative advertising.

2. What are self-regulatory codes of conduct?

1. Medicinal Products and Medical Devices

• Prescription-only Medicines (ABPI Code): The ABPI Code of Practice governs the promotion of prescription-only medicines to healthcare professionals.
• Over the Counter (OTC) Medicines (PAGB Codes): The PAGB Codes apply specifically to advertising OTC medicines.

2. General Advertising Rules

• CAP Code: Non-broadcast advertising
• BCAP Code: Broadcast advertising

3. What are the Licenses, Approvals, and Fees for advertising medicines and medical devices?

Medicines

Marketing Authorization (MA)

The MA ensures that the medicine is safe, effective, and of high quality before it can be marketed.

Promotional Material Approval

• PAGB Consumer Code: Promotional materials must be pre-vetted by the PAGB.
• Broadcast Advertisements: TV ads require Clearcast approval and radio ads require Radiocentre approval.

Medical Devices

CE Mark or UKCA Mark

Medical devices must bear either the CE mark or the UKCA mark to be lawfully advertised in Great Britain.

CE marking is accepted in Great Britain until 30 June 2028 for general medical devices and until 30 June 2030 for in vitro diagnostic medical devices.

UKCA marking is required for medical devices in Great Britain but not accepted in Northern Ireland.

Medical devices must be CE marked before they can be promoted in Northern Ireland.

Promotional Material Vetting

Promotional materials for medical devices may need to comply with the PAGB Consumer Code and be pre-vetted.

Broadcast advertisements require pre-approval by Clearcast and Radiocentre.

4. What is the differentiation in regulation between prescription-only and over-the-counter medicines?

Prescription-Only Medicines (POM)

Advertising to the general public is completely banned. Promotional materials may only be directed at healthcare professionals.

Over-the-Counter Medicines (OTC)

OTC medicines may be advertised to the general public, subject to compliance with applicable advertising laws and codes.

5. What are the restrictions on advertising medicines and medical devices to the general public?

1. Legislation – Medicinal Products

OTC medicines may be advertised to the public, while prescription-only medicines cannot be advertised except in approved UK Government campaigns.

Advertisement Requirements

• Must comply with the Summary of Product Characteristics (SmPC)
• Must not be misleading
• Must encourage rational use

Marketing Authorization Holder Responsibilities

• Retention of advertisement samples
• Details of target audience, publication method, and date

Restrictions

• Narcotic or psychotropic drugs cannot be advertised
• No misleading claims or exaggeration
• No implication that doctor visits are unnecessary
• No diagnosis or treatment by mail or electronic means
• No alarming images or misleading recovery claims
• No endorsements by professionals or celebrities
• No targeting of children
• No promotion for abortion purposes

Public Advertisement Requirements

• Clear identification as an advertisement
• Product name and active ingredient
• Necessary use information
• Invitation to read package instructions

Pre-vetting

Advertisements subject to the PAGB Consumer Code must be pre-vetted.

2. Legislation – Medical Devices

Northern Ireland

Misleading claims are prohibited under EU Regulations.

Great Britain

EU Regulations do not apply. General consumer advertising rules apply.

3. General Consumer Advertising Rules

The CPRs prohibit unfair, misleading, and aggressive advertising. The CAP and BCAP Codes require advertising to be responsible, identifiable, and supported by evidence.

6. Main restrictions on advertising medicines and medical devices to healthcare professionals

1. Medicinal Products

BPRs prohibit misleading B2B advertising. Advertisements must comply with the SmPC, encourage rational use, and be retained by the marketing authorization holder.

Strict restrictions apply to gifts and hospitality to healthcare professionals.

2. Medical Devices

BPRs apply equally. The ABHI Code governs marketing communications to healthcare professionals, requiring accuracy, balance, substantiation, and clarity.

7. Information required in advertisements directed only at healthcare professionals

1. Medicinal Products

• Marketing Authorization number and holder
• Product name, classification, and active ingredients
• Prescribing information including indications, side effects, warnings, and dosage
• Cost excluding VAT

Short advertisements are permitted with required information accessible online.

2. Medical Devices

No mandatory content prescribed. Claims must align with CE or UKCA marking and intended purpose.

8. What are the advertising requirements for medicines and medical devices?

Advertisements must clearly identify the product, its active ingredient, instructions for use, and include an invitation to read instructions.

Advertisements must clearly indicate that they are advertisements and that the product is a medicine.

9. Requirements for scientific data in advertisements

Medicinal Products

Claims must be accurate, balanced, fair, and objective, supported by up-to-date evidence with clear references.

Medical Devices

Claims must not be misleading and must be supported by high-quality, relevant, and credible evidence.

10. Rules governing comparative advertising

Public advertising must not suggest superiority or equivalence. Comparative advertising must comply with BPRs and applicable codes, ensuring accuracy and fairness.

11. Advertising medicines and medical devices on the internet and social media

Medicinal Products

Prescription-only medicines may only be advertised on websites directed at healthcare professionals. Social media promotion of POMs is prohibited.

Mandatory information may be provided via links to the SmPC.

General Comments

Online advertising is subject to the same rules as traditional advertising. Companies must monitor online content for adverse event reporting and off-label promotion risks.

12. Enforcement mechanisms and legal consequences

Medicinal Products

MHRA may impose unlimited fines and imprisonment of up to two years. Senior management may be personally liable.

PMCPA enforcement under the ABPI Code may result in public reprimands, administrative costs, or expulsion.

Medical Devices

MHRA and Trading Standards may impose unlimited fines and imprisonment of up to six months.

General Advertising Enforcement

Trading Standards, CMA, and ASA enforce compliance and may require advertisement removal or sanctions.

13. Future developments in the UK

13.1 Medicinal Products

Northern Ireland remains subject to EU law until at least 1 January 2027. No significant short- term changes are expected in Great Britain.

13.2 Medical Devices

See section 1.2 above.

How can OMC help?

• Professional review of marketing and advertising materials with reports
• Services to obtain authority approvals where required
• Translation of marketing materials by a professional translation agency certified with ISO 17100