Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?Medicinal products
The promotion of medicinal products in the European Union is controlled by a combination of legislation and self-regulation through the industry codes of conduct, mainly the European Federation of the Pharmaceutical Industry Association (EFPIA) Code of Practice 2019 (the EFPIA Code), which covers the promotion of medicines to healthcare professionals (HCPs) and the interactions with those HCPs, healthcare organisations (HCOs) and patient organisations (POs). The EFPIA Code is designed to be implemented by its national member associations. In practice, the interpretation of the legislation and EFPIA guidance is determined at a national level.
EU law provides different rules for advertising of medicines to the public and advertising aimed at HCPs. Advertising to the public is permitted for medicines legally classified as non-prescription, while advertising of prescription-only medicines may only be targeted at persons qualified to prescribe or supply medicines. Advertising of unauthorised medicines or indications is not permitted. All medicine advertising must be consistent with the approved summary of product characteristics.
Under Directive 2001/83/EC, advertising is defined as ‘any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products’. Therefore, corporate or financial information describing a company’s area of business and progress in research will likely fall outside the definition, provided it is not presented in a promotional style and includes no claims in relation to medicinal products or medical treatments and does not encourage patients to ask their doctors to prescribe a particular product.
Online advertising is regulated under the same provisions and controls as traditional advertising, although the various industry codes of practice have been updated in recent years to add provisions specifically aimed at use of the internet by the industry, including the use of online platforms and social media.
The EU laws governing the promotion and advertising of medical devices are less detailed than those established for medicines, although EU general consumer legislation on misleading advertising also applies. The new medical device regulations introduce a new requirement concerning promotional claims that expressly prohibits the making of claims, when promoting a medical device, that may mislead the user or the patient with regard to the device’s intended purpose, safety or performance.
From a self-regulation perspective, at the EU level, the largest medical device manufacturer’s industry association, MedTech Europe, issues a Code of Business Practice (the MedTech Code), which is obligatory for its member associations and member companies, and regulates their interactions with the medical community and other stakeholders. This also covers online advertising.Inducement
What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?Medicinal products
Directive 2001/83/EC prohibits the supply, offer or promise of gifts, pecuniary advantages or benefits in kind to persons qualified to prescribe or supply medicines where medicines are being promoted, unless they are inexpensive and relevant to the practice of medicine or pharmacy. This prohibition is required to be reflected in the national laws of all member states. Hospitality extended to HCPs is considered acceptable in the context of promotional events, provided it is limited to the main purpose of the event and offered to HCPs only.
The EFPIA Code reflects these restrictions, prohibiting gifts for the personal benefit of HCPs, HCO members and PO representatives (either directly or indirectly). Providing cash or offering cash, cash equivalents, promotional aids (non-monetary items given for promotional purposes) or personal services is also prohibited. Personal services are any type of service unrelated to the profession and that confer a personal benefit to the recipient. Donations and grants to HCOs and POs are allowed under strict conditions, but donations and grants to individuals are not permitted.
Given the private nature of Notified Bodies, both the medical device directives and the new medical device regulations require Notified Bodies to carry out their assessments and verifications with the highest degree of professional integrity and free from all pressures and inducements, particularly financial, which might influence their judgement, especially from persons with an interest in the results of the verifications.
From a self-regulation perspective, the MedTech Code prevents member companies from offering and providing educational grants to individual HCPs with certain exceptions, and has phased out the provision of financial or in-kind support directly to individual HCPs to cover costs for their attendance at third-party organised educational events (with the exception of procedure training). It also sets out transparency obligations with regard to all interactions with HCPs, in terms of notification to the HCP’s superiors or relevant health institutions before the interaction may take place, disclosure of payments (made as educational grants) and a centralised platform for the approval of conferences and other events (the Conference Vetting System).Reporting transfers of value
What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?Medicinal products
EU law does not set out requirements for recording or publishing the details of transfers of value (ToV) to HCPs by pharmaceutical companies. Requirements are, however, imposed by the national legislation of some European countries and by the self-regulatory codes.
The EFPIA Code provides for disclosures of ToV made to HCPs and HCOs, whether directly or indirectly. When deciding how a ToV must be disclosed, member companies, must, wherever possible, identify and publish relevant information at the individual HCP level (rather than the HCO level) as long as this can be achieved with accuracy and consistency and in compliance with applicable laws and regulations. The items to be disclosed are those ToVs relating to donations and grants (to HCOs), contribution to costs related to events and fees for service and consultancy. Where certain information cannot reasonably be allocated to one of these categories or cannot be disclosed on an individual basis, member companies must disclose the information on an aggregate basis. Research and development ToVs must also be disclosed on an aggregate basis. Disclosures must be made pursuant to the national code of the country where the recipient has its professional address and on the company’s website or on a central platform, depending on national requirements.
With regard to POs, each EFPIA member company must disclose a list of POs to which it provides financial support or significant indirect or non-financial support or with whom it has engaged to provide contracted services for that member company. The information to be disclosed is the name of the PO, the monetary value of the financial support, the non-monetary benefit that the PO receives and the total amount paid per PO for contracted services over the reporting period. The information must be disclosed on the member company website at national or European level.
As with medicinal products, there are no legal provisions at the EU level requiring medical device companies to disclose payments to HCP, HCOs or POs. However, there are requirements to disclose certain ToVs under the national laws of some member states and under the MedTech Code.
Under the MedTech Code, member companies must document and publicly disclose all educational grants in accordance with the Code’s disclosure guidelines. Educational grants include support for third-party organised educational events, grants for public awareness campaigns and scholarships and fellowships. Each member company must disclose all payments related to their educational grants to HCOs based in Europe without limitation of value. Amounts paid to each recipient HCO will be aggregated on a category-by-category basis but will need to be itemised upon request from the competent authorities. The disclosure may be made on the MedTech Europe website or on the national platform, if one is set up under national rules.
Enforcement of advertising rulesEnforcers
Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
Traditionally, the enforcement of the EU provisions regarding advertising of medicinal products and medical devices is undertaken at a national level by the national competent authorities or the national self-regulatory bodies.Sanctions
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
Sanctions for breach of national legal provisions on advertising vary from fines or imprisonment of responsible individuals under a criminal law framework to administrative fines in certain jurisdictions. Sanctions may escalate if the breach of the advertising provisions is linked to an illegal inducement of a healthcare professional (HCP) and the matter falls within the remit of the national anti-bribery law or there has been a breach of the antitrust rules.
Under the self-regulatory systems, sanctions for breach of national self-regulatory codes include fines, publication of cases, issuance of corrective notices to HCPs, audits and ultimately suspension or cancellation of the company’s membership to the relevant national industry association and potentially of corresponding European industry associations, such as the European Federation of the Pharmaceutical Industry Association and MedTech.
Pricing and reimbursementPricing
What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
The controls on pricing of medicines and medical devices and decisions regarding reimbursement of these products by national social security systems applicable to manufacturers, distributors and pharmacists are established exclusively at a national level. EU law only contains certain provisions requiring the transparency of such national controls and how they are applied.
Sale and supplyRegulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?Medicinal products
When a marketing authorisation for a medicinal product is granted at the EU or national levels, the conditions and restrictions under which the medicinal product should be made available to patients (the ‘legal status’ of the medicine) must be included as part of the authorisation.
Directive 2001/83/EC sets out levels of categories in relation to legal status. The medicine is first classified either as subject to medical prescription or not. For products subject to medical prescription, member states may use a second level: medicines subject to special medical prescription, medicines subject to restricted medical prescription and medicines subject to renewable or non-renewable delivery.
In addition, the summary of product characteristics of the product may include an explanation on how the medicine should be supplied to patients (ie, to be administered in a hospital setting or prescribed by specialists only) or on the specific type of care required during the treatment of a chronic disease.
The dispensing, sale and use of medical devices is set out in the device’s labelling and instructions for use, which will specify, for example, if the device should be used by a healthcare professional.Online supply
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
EU law does not prevent the dispensing, sale and supply of medicines or medical devices online. However, patients are encouraged to only use online retailers registered with the national competent authorities in the EU member states, to reduce the risk of buying substandard or falsified medicines and medical devices.
The EU requires the use of a common EU logo for legally operating online pharmacies in EU countries. The logo links to the website of the national competent authority listing all legally operating online pharmacies so users can confirm the website is legitimate and that the retailer is registered. The national flag and the text are an integral part of the logo; a logo that displays the EU flag is not authentic.