The ABHI Code of Business Practice was launched in 2009, but many medtech sales and marketing professionals - and their customers - are still getting used to it. Compliance specialist Steve Gray looks at how the Code guides your business route.
For some time, pharmaceutical company employees have looked at their colleagues in the medical technologies industry with a bemused envy. As the pharmaceutical industry's Code of Practice became ever stricter, there did not seem to be a visible comparator for medical device companies - and stories about tickets to rugby games and golf matches continued to circulate.
Now that has changed. Our major industry associations, ABHI and BIVDA, have launched their own Codes of Practice.
For some in the healthcare industry, the bells of fear and horror will now toll. Having heard the dreadful tales of SOPs and form-filling emanating from pharma, knees will shake at the thought of healthcare being subjected to the same pressures. Others will welcome the clarity that the Code will bring to their professional activities.
This article is the first in a series that will examine the ABHI Code, its reason for being and its implications in working practice.
Why it matters
Why do we need a Code? We seem to have done perfectly well as an industry up to now without one. What's changed?
The short answer is: quite a lot. The public demands increasingly high standards from government employees - the MPs' expenses scandal being the highest-profile example in recent months. Who would have thought, just a year ago, that the public would demand curbs on the bonuses paid to city traders?
Industry associations in a very wide range of business sectors are developing and implementing professional codes of conduct. Even football players and nightclub bouncers have codes of conduct.
The public is outraged when hospitals are unclean, patients have poor experiences in hospital and public safety is placed at risk. The NHS is facing increasing cost pressures, and the public perception that healthcare companies spend inappropriate sums on hospitality and promotion has become one of the drivers of change. Given the role of medical technologies in diagnosing and treating human illnesses and frailties, it is important that we act in a manner that inspires confidence in our products and companies. There is also a need for a common framework to ensure that all medtech companies are judged according to the same standards.
Setting a standard
The Association of British Healthcare Industries (ABHI) Code of Business Practice was introduced in February 2009. Awareness of the Code is still growing, and its profile will increase over the coming months and years until we will forget that there was ever a time we operated without it. The British In Vitro Diagnostics Association (BIVDA) has introduced its own Code of Conduct along similar lines.
The introduction to the ABHI Code states that members recognise their obligation to comply with "applicable laws and regulations" and to adhere to ethical standards because they know that compliance can enhance the reputation of the industry. In fact, the maintenance of high standards is seen as a "critical step" in the industry's being seen to contribute credibly to the well-being of patients.
The ABHI Code defines minimum standards that it expects members to achieve. In practice, company policies are likely to go further than the Code itself requires, especially if the company is subject to US laws such as the Foreign Corrupt Practices Act (FCPA).
Readers who are familiar with the Eucomed Code of Practice will recognise much of the ABHI Code, because the UK association was integral to the development of the European standards. In effect, there will be similar standards in every country in Europe. And many of the principles are common to a variety of codes across the life sciences sector.
Playing by the rules
The ABHI Code incorporates eight key policies:
• Quality and regulatory compliance
• Interactions with healthcare professionals
• Advertising and promotion
• Unlawful payments and practices
• Competition/antitrust and procurement laws
• Export controls and sanctions
• Environmental issues
• Data privacy.
These core policies are underpinned by a ninth: Compliance and enforcement. The ABHI is serious about ensuring that its members comply with the Code (see below).
In general, the Code requires members to produce, supply and promote medical devices and related services in accordance with existing regulations and good ethical practices. For example, it says about data privacy: Members should ensure that patient data and other types of confidential or personal data be maintained and used in accordance with applicable legal requirements.
The detailed requirements of data privacy in the UK are defined and policed by the Information Commissioner's Office, which gives advice regarding compliance with the Data Protection Act. The ABHI Code does not need to go into the details regarding data privacy - but it makes it clear that the ABHI expects its members to members to follow the law.
Two areas of ABHI policy are covered in some depth within the Code: interactions with healthcare professionals and competition law. We will cover the details of these in a future article. Regarding competition law, it is sufficient for now to note that ABHI members should not share competitive information with each other.
Brief but clear guidelines
Colleagues who have worked in both the pharma and medtech industries will recognise similarities between the ABHI and ABPI Codes regarding interactions with healthcare professionals. For example, speakers at educational meetings will now have to be formally contracted for the services they provide. ABHI members must not provide lavish hospitality, or use anything other than reasoned argument and product demonstration to influence their customers. Lunches in five-star hotels, golf days and favouring grant applications from good customers are definitely not approved!
In general, the ABHI Code is very focused in its requirements and is less onerous than its pharmaceutical cousin. However, there are a few areas where it is actually stricter - for example, donations and grants cannot be paid to an individual HCP. (An individual HCP can apply for a grant, but the cash transfer must be between the healthcare company and the Trust the HCP works for.) This is to prevent any misunderstanding that might arise if a representative were giving a cheque to an HCP.
The ABHI Code highlights the need for good quality promotional material. It summarises this in three sentences: Members should ensure that all promotional presentations, including product claims and comparisons, are accurate, balanced, fair, objective and unambiguous. They should be justified by appropriate evidence. Statements should not mislead the intended audience.
There is no requirement for formal certification of promotional material by nominated head office signatories, or the onerous review procedures so common in pharmaceutical offices. The ABHI Code expresses in those three sentences, what the ABPI code takes two and a half pages to say.
But do not be mislead by the brevity. The ABHI is serious about the need for members to comply with the Code - indeed, compliance is mandatory. There is a defined complaints procedure and a formal Complaints Panel to rule on disputes. Companies will need to prove their compliance with the Code if a complaint arises.
Enforcing compliance
The sanctions that the Complaints Panel can impose on a company include:
• Reprimand.
• Imposition of a requirement that the offender take specific actions to ensure compliance with the Code.
• Inspection and audit by a third party, at the offender's expense, of the offender's systems for compliance.
• Requiring the offender to recover items given in connection with the promotion of products.
• To issue a customer communication regarding future corrective practice (in effect, an apology to customers).
• Requiring the offender to publish or otherwise disseminate corrective or explanatory information or statements (in effect, a public apology).
• Withdrawal of a 'compliance' logo or equivalent industry accreditation or certification.
• Publication of any decisions or sanctions imposed in such manner or media as may be specified (a public release indicating the offender's bad practice, or an actual public reprimand).
• Suspension from membership of the Association for such time period as may be specified, and readmission on such terms as may be specified.
• Expulsion from membership of the Association.
Many of these sanctions rely on the threat of public embarrassment to drive compliance. That may not sound like much, but it's the kind of thing that breaks CEO careers! Examples of cases and rulings from the pharmaceutical industry have long been visible on its ruling body's website (www.pmcpa.org.uk). A quick read of these cases gives an impression of the issues that the medtech industry may face should the ABHI adopt similar behaviour-monitoring approaches.
Of course, many of the requirements of the Code are enshrined in law - or at least are designed to keep companies on the right side of the law. As was mentioned above, companies with a US presence will be particularly aware of the implications of failing to maintain standards. There are circumstances in which the actions of a company anywhere in the world can lead to fines (and even jail sentences) for its US division. European law enforcement agencies provide considerable assistance to the US when FCPA cases are investigated.
Code read
Of course, the Code is ultimately in our best interests. As the ABHI says, the industry prides itself on making "a significant contribution to the safety and well-being of patients and the improvement of healthcare systems." It would be irresponsible to undermine the positive impact of our products and services by allowing our customers to develop a negative view of our behaviour.
By publicly declaring and pursuing high standards, we can create and maintain a positive environment in which our customers are more receptive to information that will help them to make informed purchasing decisions.
We are at the start of a new era in public scrutiny. The Code will help us to stay in the spotlight for the right reasons.
Steve Gray is an experienced compliance specialist. His company produces training materials, workbooks and distance learning courses designed specifically for companies and sales teams working with the ABHI Code of Practice. For more information, visit www.stevengrayconsulting.co.uk.
We are at the start of a new era in public scrutiny. The Code will help us to stay in the spotlight for the right reasons.
