IPCAA NEWSLETTER

IPCAA educational workshop hailed as great success

The workshop took place on Dec 09, 2009 in Frankfurt, attracting more than 40 participants; for the first time ever delegates were drawn from outside IPCAA membership, with almost one third of those present representing medical societies. To stimulate a true inter-disciplinary approach to discussions and interactive sessions, colleagues from the medical device and equipment industry were also in attendance.

Rather than focusing on theoretical aspects of laws and regulations the programme concept was aimed at practical implementation: real life examples, formal presentations, sessions allowing input from various stakeholders and inter-active case discussions using business simulation game technology - all played a part in raising awareness of compliance issues.

Marc Merckx, from ISMS Consultancy, (contact www.ismsbelgium.be), who created the programme content for IPCAA, introduced the workshop and stated that healthcare compliance and business integrity concerns all company staff and requires a multi-functional approach.

The workshop started with three very informative presentations from guest speakers:

Gabor Danielfy
Senior Director, EMEA World Wide Office of Health Care Compliance & Privacy, Johnson and Johnson

During a presentation entitled “Compliant cooperation with external Stakeholders - What's acceptable, what's questionable and what's over the line?“, the audience was able to benefit from Danielfy's considerable experience and knowledge on topics such as the relationship between values, rules and perception, emphasising that appropriate rules are born out of basic company and individual values and cultures.

Whilst a solid set of rules is needed, all cases or situations cannot be the subject of a law or regulation and therefore it is commonly accepted that a Value Based compliance programme is the answer. However, nowadays this has become insufficient and it is therefore increasingly important to address appearances and perceptions. As a result a programme should be ‘Value based, Rules shaped, and Perception optimised !

In an industry which is constantly under media and public scrutiny, business integrity and complying with reasonable standards of behaviour has to be seen to take place. Actions and events in which pharmaceutical companies (as well as, increasingly, other healthcare corporations) and other parties collaborate to provide vehicles for exchange of information and knowledge for healthcare professionals have to be able to be viewed as “acceptable” from a public viewpoint, from competitors as well as in the eyes of healthcare professionals themselves.

Acting responsibly, in accordance with rules laid down by companies and industry associations, as well as being aware of actual legal constraints and managing complexity is a must for all employees in healthcare firms. Infringements are usually subject to sanctions which can be severe for serious breaches.

Also active as co-chair of the EFPIA (European Federation of Pharmaceutical Industries and Associations) Information to Patients Task Force as well as being involved with the Code Compliance Network of IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), Paul Woods was ideally placed to comment on aspects concerning industry codes, their development and trends.

The various “rules” to which pharmaceutical companies operate (at international, regional and national levels) were described as a “jungle” of advertising codes, legal regulations, voluntary industry codes and individual corporate compliance or ethical policies, in order to reinforce the point that this is a highly complex area.

Interestingly, Woods reported that feedback from certain countries shows improved implementation of national codes, but that real progress has come from the development of internal company codes, which tend to be more specific and therefore leave little or no room for misinterpretation!

In practice, he felt that more education on code and issues arising needs to be provided – not just within the healthcare industry, but for all organisations who interact with healthcare companies and that neither politicians nor the public should be forgotten among this grouping.

Looking ahead, Woods expressed the view that the future should see an era of partnership between industry, healthcare professionals and patients, with companies increasingly considered as part of the healthcare “team”. Codes will continue to be the main quality control mechanism, but it is highly likely that physicians, pharmacists, nurses and patient groups will also create their own codes to both reflect their responsibilities towards commercial enterprises and their own commercial influences.

The alternative to such a “codes-driven” world, would be for more and tougher legislation to continue to be introduced, to regulate everything possible in terms of interactions involving any aspects of healthcare. Those present felt this solution should be avoided if at all possible.

Luciano Cattani also holds the position of Vice Chairman of the Board of EUCOMED (a European trade association representing manufacturers of medical devices and equipment). He was therefore able to provide a very useful insight into both the similarities and differences of processes and challenges between the pharmaceutical and medical equipment industries.

Certain differences in activity and structure of their business environments previously meant that ethical and behavioural codes and rules for interactions with healthcare professionals may have been considered at one time uniquely the preserve of pharmaceutical industry. However it is now abundantly clear that today's situation places all healthcare industry suppliers very much on a line of convergence on matters of voluntary industry codes to regulate actions and ensure reasonable and publicly acceptable rules of behaviour.

(For anyone not familiar with EUCOMED, we recommend you check the website www.eucomed.org, where a number of useful downloads relating to EUCOMED industry codes of ethics are available).

After the highly informative presentations from the guest speakers, the participants were split into small groups in order to use a newly-developed “business simulation game” software as a means of introducing some taste of reality into the workshop. Real life simulation scenarios offer the players a concrete impact evaluation by a series of decisions as well as the opportunity to make corrective actions. Each group were issued with a laptop programmed with certain business scenarios (from a pharmaceutical marketing operational viewpoint).

At each step of the exercise, group members had to agree on the next business decision to be taken. Although there were no “Right” or “Wrong” answers the impact of the group decision was then displayed in terms of impact on various other parties, such as congress organisers, legislators, regulators, public, press as well as company legal departments, colleagues and management.

In what turned out to be a very compelling exercise, it quickly became clear to those involved that the old adage of not being able to “please all of the people, all of the time” was more than ever true when having to apply considerations on compliance issues and regulatory aspects! When you have for example, planned a big product launch promotion at a world congress and agreed to be a major sponsor and then your product registration is delayed, you have to quickly learn the art of compromise, diplomacy and above all, how to be compliant! After three rounds of the game, colleagues from outside the healthcare industry were starting to say “I'm beginning to see what problems you must have to face sometimes!”

Participants all agreed that the day's workshop was an ideal mix of the formal and informal, with plenty of discussion, question time and also lots of opportunity for informal networking.

Sylvia Fondanèche, IPCAA Vice President and coordinator of the workshop, thanked Marc Merckx for arranging the programme and for the use of the business game which had been developed with his input and also thanked the expert guest speakers for their superb contribution to the success of the meeting. She later said “It is clear that with a competent faculty and an attractive format, workshops of this kind can be extremely useful as a tool in our ongoing educational efforts, to promote knowledge on compliance and regulatory issues. After the success of the event this time, we shall certainly be looking to offer more opportunity for interested parties from outside the pharmaceutical industry to participate in learning sessions of this kind – the greater the extent to which compliance rules are understood by everyone involved in medical meetings, the better for all concerned.”