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When knowledge is power in pharma regulatory compliance

With full understanding of the rules it is possible to respect regulatory compliance without compromising effective communications

Knowledge power appleOf all marketing disciplines, healthcare public relations (PR) may be the one that is most directly affected by the evolving regulatory environment and changes to it. This year marks the 50th anniversary of the UK's Association of the British Pharmaceutical Industry (ABPI) and with it come updates to the ABPI's Code of Conduct. These changes reflect those made by the European Federation of Pharmaceutical Industries and Associations (EFPIA) to ensure the pharmaceutical industry and its stakeholders can have the maximum confidence in the standards set for ethical and responsible behaviour of companies and staff.

Healthcare PR professionals are the builders and custodians of relationships, albeit with third parties, opinion leaders or media. They are corporate image and reputation protectors and partners in facilitating scientific exchange. Any changes to the EFPIA Code of Conduct, and the local governing codes, directly affect how healthcare PR agencies do business. For this reason, certification and ongoing investment in regulatory training should become a clear mark of distinction in the selection of healthcare PR agency partners.

Healthcare PR agencies cannot simply be 'committed' to compliance; they need to be invested in it at all levels of the organisation, from the most senior director to the newest recruit. No member of the team is protected from the need to know what constitutes promotion, or bribery or a lack of transparency. It is the responsibility of the agency to uncover and address knowledge gaps that may affect compliant communication.

The reason for this is, simply put, that the stakes are high. Aside from the financial implications of penalty fines and legal fees and the risk of criminal prosecution, straying from the rule book brings the industry into disrepute, which undermines the role of the healthcare PR consultant whose role it is to help a company or brand build and tell a positive story.

Additionally, research shows that PR healthcare staff who have undergone training and certification in communication compliance report a significant increase in confidence and satisfaction in their work. By making compliance education part of professional development, agencies are demonstrating commitment not only to enhancing the working lives of their staff but to protecting their clients' own reputations.   

Creative compliance
The challenge for health communicators within PR agencies is no longer to walk into the room with 'creative business ideas'; it is the development and implementation of 'creative compliant business ideas' that make agencies stand out. Gone are the days when 'getting a launch campaign through legal' was something clients were expected to navigate. Nowadays it is about mutual responsibility.

The 'worry about regulatory approval later' mentality is nothing short of pitch suicide. No matter how clever, creative or compelling an idea is, if it does not meet the approval of regulatory, with relatively minor adaptation, it will only mean more work, lost time and increasing costs for both the client and agency, which is not a healthy start to what should be a long-term partnership.

Local nuances
The fact remains that many global and pan-EU communications programmes can stumble at the start unless local market nuances and code adherence are considered early in the conception. Multi-country teams or a compliance point person on both the consultancy and client side can help ensure the development of a global communication recommendation is both robust and implementable with minor adaptation needed once it enters a local review process.

While the initial outlay of a rigorous compliance training and certification programme may be significant, it is easily recouped through effective plans that are executed with minimal change. Agencies have a responsibility to ensure media materials and recommendations are vetted for compliance before going to a client.  Access to on-demand counsel from an external regulatory communications expert can be valuable and reassuring, especially during the sensitive pre-licence phase.     
 
Earlier intervention
Furthermore, it is not just the national codes of practice that agencies need to comprehend. The onus is on the PR agency to really understand the internal regulatory clearance process. The need for earlier engagement of legal and regulatory in the development of communications programmes, sitting at the table in round one and not down the corridor and only involved at final sign off, is a simple but critical step.

As partners in business, agencies are responsible for building closer relationships between healthcare communication consultancies and client medical and regulatory teams. The goal is that ultimately everyone is speaking the same language, moving from reactive to proactive conversations. 

Despite the rules and restrictions, what is important is to ensure that agencies do not become paralysed by fear or become bystanders of creativity. Consider where and how the creative process should start; operating in a highly regulated area does not mean agencies cannot start with the idea and creative spark and then work through the regulatory environment and challenges, rather than the other way around. Recognition that creativity can be owned by everyone on both client and agency side is a smart way to ensure people in regulatory roles have an opportunity to engage earlier and contribute to the idea generation process.

Social media in practice
The need for greater industry collaboration and practical guidance on compliant communication, especially in relation to social media, will be critical to the success of digital pharma. The emergence of working committees and professional bodies in Europe focused on this topic will help share best practice and provide practical advice on engaging with the digital world. While many contest the regulatory environment is 'murky' when it comes to social media and online engagement, there are recent precedents that outline a path that is both compliant and mitigates risk. The development of a definitive code for social media marketing seems to be unlikely based on the US Food and Drug Administration decision that it will not make platform-specific guidelines. This means the onus remains on healthcare communication agencies and the pharmaceutical industry to coordinate efforts to share experiences, learn from others and create formal plans in the absence of strict social media regulations and guidelines.

Some of the most creative minds are in the healthcare industry and some of the most effective campaigns have been implemented on behalf of pharmaceutical clients. Recently healthcare PR campaigns have received accolades and distinction at the prestigious Cannes Lion International demonstrating that creative compliant business ideas are not only possible in the pharmaceutical PR world, but can outshine creativity and ideas born from far less regulated environments.

Test your regulatory knowledge

(Click on the question to see the answer)


1. Which statement is true with regard to how to apply the different codes when conducting promotional activities in a European country? (select best answer)

A.    If a company is promoting in its own country, then its local country code is applied to the conduct of the promotional activities, plus the EFPIA code

B.    For a non-European company promoting in a European country, the EFPIA code would need to be considered, along with the local code in the country in which the promotional activities are taking place

C.    If a European company based in one country is promoting in a second European country, then the national codes of both countries and the EFPIA code apply

D.    If there is a conflict between codes of different countries, the more lenient code always prevails

E.    Only A, C, and D are true

F.    Only B and C are true

G.    Only A, B, and C are true


2. During an international meeting, in which countries is a company allowed to display openly off-label information if it is accurate, factual, balanced and done pursuant to scientific interest? (select the three best answers)

A.    Spain

B.    Germany

C.    France

D.    UK

E.    Italy


3. Which of these statements is true about consultancy arrangements in the five countries? (select best answer)

A.    While market research could be seen as a form of covert promotion, only three countries – Italy, France, and Germany – explicitly prohibit a consulting agreement from including such activities

B.    While all five countries permit remuneration of consultants for legitimate services provided, in only three countries – UK, Spain, and Germany – is a company also allowed to pay consultants for their travel costs and the time spent preparing for a meeting

C.    Italy and Spain are the only countries that permit a consultant's eminence to be a factor in a company's determination of his or her pay rate

D.    The UK is the only one of five countries that permits a consultant's eminence to be a factor in a company's      determination of his or her pay rate

E.    None of the above


4. Which statement below is true in all five countries with regard to a website intended for the general public? (select best answer)

A.    The site must include, for each product discussed, all of the following: the prescribing information, black triangle (if appropriate), and the International Non-proprietary Name (INN)

B.    The company must make clear when a visitor is leaving the company's public website and going to a third-party site not controlled by the company

C.    The address of the website must be included in product labelling and in patient information leaflets

D.    The site should encourage consumer visitors also to go to the company's website for HCPs since the company can be certain that its HCP site will contain no off-label material

E.    All the above

F.    None of the above


Answers:
1. G
2. A, D, E
3. E
4. B

Click here to return to questions


Source:  Regulatory Compliance European Comparator Test, Centre of Communication Compliance.



Rachael Pay, Weber ShandwickTorsten Rothaermel, Weber ShandwickThe Authors
Rachael Pay
(left) is managing director, Weber Shandwick Health Europe and Torsten Rothaermel is managing director, Weber Shandwick Health Germany.

2nd July 2012

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