Regulation imposes consistency on the rapidly-changing world of medtech. But regulation itself is diverse and changeable. Where should the sales or marketing professional start? Chris Freer of Pharmalink Consulting offers a rough guide to the regulatory environment.
For any company working in the highly competitive and innovative field of medical technologies, knowledge of the regulatory environment is a gateway to customer access and commercial opportunity. But for many start-up companies entering this field, the regulatory environment can appear difficult and confusing.
One particularly complex area is the promotion and sale of medical devices and technologies. However, the Eucomed guidelines on this topic are intended to protect the medtech industry, as well as safeguarding the interests of customers and patients, by establishing standards in product performance and business practice. Eucomed (see www.eucomed.be
) is an association representing the interests of European medical technology manufacturers.
A wave of red tape
The healthcare industry is a complex and diverse miscellany of products and services, swimming in a sea of regulation that is just waiting to form a tidal wave and sink the finest entrepreneurs endeavouring to break into the market. In the fast-moving, innovative world in which we live, the need to regulate has overtaken more basic principles in more or less all aspects of our lives. It should come as no great surprise, therefore, that the medtech industry has followed suit.
In recent years the healthcare industry, and in particular the medical technologies sector, has seen a surge in directto- consumer advertising (DCTA) and promotional campaigns. The fact that DCTA has been largely effective and lucrative for the pharmaceutical industry has spurred on medtech companies to try their hand at this marketing approach. By the same token, the medtech industry has been forewarned by the regulatory ‘red flags’ that have been raised over some pharma companies’ direct-toconsumer tactics.
The devil in the detail
There are no specific laws or codes relating to the advertising and promotion of medical devices and technologies. Promotion is, however, subject to the general laws on advertising and promotion – including the EU Directive on Misleading and Comparative Advertising (84/450/EEC), which has been amended several times and is currently in the process of being codified. In addition, advertisements in the UK must comply with the Control of Misleading Advertisements Regulations 1994, the Trade Descriptions Act 1968 and the Television and Radio Advertising Standards Codes (where appropriate).
Comparative claims are allowed, provided that they are objective and do not mislead. Brand names of competitors may be used. If an advertiser fails to comply with the regulations, the Director General of Fair Trading may obtain an injunction to prevent the further publication of a misleading advertisement. In addition, the Trade Descriptions Act 1968 makes it a criminal offence to issue a false or misleading trade description.
In the case of an advertisement referring to the merits of a medical device used to administer medicines (such as an inhaler or a pre-filled syringe), even if no particular medicine is mentioned, Clause 4.1 of the Association of the British Pharmaceutical Industry (ABPI) Code states that the advertisement must include prescribing information relating to at least one medicine.
Where to look
Information about the Trade Descriptions Act and the Control of Misleading Advertisements Regulations can be found at the Office of Public Sector Information (see www.opsi.gov.uk/index.htm
). The Advertising Standards Authority regulates the content of advertisements, sales promotions and direct marketing in the UK, and is a very good source for information regarding television and radio advertising standards (see www.asa.org.uk/asa
Reaching the public
The Medical Device Directive 93/42/EEC does not give any guidance on the marketing and sales of medical devices. It concentrates on the registration and responsibilities of people responsible for placing devices on the market in terms of labelling and instructions for use, thus ensuring the quality, safety and efficacy of the product. This allows individual countries the freedom to impose their own regulations on marketing and sales.
The regulation of direct-to-consumer advertising is different all over Europe. Some countries (such as Austria, the Czech Republic and Italy) prohibit DCTA of medical technologies, which can be administered only under the supervision of a healthcare professional.
These would include most Class III medical devices. Other countries (such as France and Hungary) prohibit DCTA of reimbursed products. Finally, in some countries (such as Germany, the UK and Greece) it is legal to advertise to the consumer as long as the advertisement is balanced and objective.
The use of disease awareness campaigns is allowed throughout Europe, as long as the campaign does not focus on a particular product or group of products. It is therefore possible to distribute educational material about a disease, and this may carry the name of the company as a promoter of the campaign. This might give the patient the subliminal message that the company has a product that can help them with their disease, and is thus advertising ‘by the back door’.
There are no uniform regulations across Europe that can be accessed to help the small manufacturer ensure it is acting within the law when advertising to the general public. Many of the European Health Authorities have websites with regulations – but these tend to be in the local language only, so for a small manufacturer without the benefit of local offices, finding out can be difficult and/or expensive.
Often, help from specialist consultants can offer a way forward; but sometimes a phone call to the local health authority will tell you everything you need to know. A good starting point for finding such information is the Heads of Medicines Agencies website www.hma.eu
. The European Commission home page at www.ec.europa.eu/index_en.htm
also has excellent links to a vast website of EU policies, guidelines and other information on many topics.
One final website that may be worth consulting is the European Public Health Alliance or EPHS (see www.epha.org/
), which represents over 100 non-governmental and other not-for-profit organisations working within the public health industry across Europe.
The fact that DCTA has been largely effective and lucrative for the pharmaceutical industry has spurred on medtech companies to try their hand at this marketing approach. By the same token, the medtech industry has been forewarned by the regulatory ‘red flags’ that have been raised over some pharma companies’ direct-to-consumer tactics. Chris Freer works for Pharmalink Consulting as a Regulatory Affairs Executive. He held positions in Regulatory Affairs Management with global medical device manufacturing companies. Chris is also the Chairman of the TOPRA Medical Device Technologies special interest group. TOPRA is the global organisation for regulatory affairs professionals and for those with an interest in regulatory affairs in the healthcare sector.
Pharmalink Consulting is the world’s largest independent pharmaceutical regulatory affairs consultancy, with offices in the UK, USA and India. They assist the world’s leading companies with regulatory affairs functions, and are experts in the areas of pharmaceuticals, biotech, clinical, consumer healthcare, medical devices, nutraceuticals and veterinary regulatory affairs.