Transparency Code – Benefits for whom?
Presentation at a cooperation event in September 2014
Sometime in the first half of 2016: The pharmaceutical companies have just published their payments to doctors and specialists for the first time and were able to explain that they had only made earmarked expenditures, and now they are enjoying their increased reputation as a result. The doctors can finally show that they have only enjoyed specialist training for the good of all, and not even at the expense of the patients. Patients can see that the doctors of their choice have taken advantage of further training exclusively for the sake of better patient care and have not received any other inappropriate services. – Very good – The associations, both of the companies and the doctors, have pulled together and put their respective members in a better light through the voluntary commitment. The politicians, “we dear voters have only ensured through our political pressure that the system becomes more transparent and less corrupt”. – So are there only winners and we can go straight to dinner?
What is the situation today?
Transparency Code – what is it and who does it concern?
The pharmaceutical industry and doctors, pharmacists and medical professionals have been working together for a long time through fruitful exchange. This exchange is essentially based on expertise on the one hand, with the background of improving care, and appropriate remuneration for this service on the other. To regulate this, the FSA e.V. has in the past issued the Code for Cooperation between the Pharmaceutical Industry and Physicians. The name is FSA Codex Professionals and you should all be familiar with it. This code was recently present in the media when the new version dealt with the prohibition regarding the distribution of gifts and free-of-charge materials.
In order to counter even the slightest appearance of possible conflicts of interest, the so-called Transparency Code is now also being introduced in response to social and political pressure. It is intended to further improve public understanding of the high value of this cooperation. It, I would like to quote, “supplements the proven standards of conduct of the FSA Code for Professionals and the FSA Code for Patient Organisations and puts the cooperation on an even sounder footing in future”. The German Medical Congress already articulated its approval and support in 2013.
Transparency Code – What is to be done concretely?
Within the scope of EFPIA, payments and benefits in kind to organisations, medical professionals, doctors and pharmacists are to be disclosed within the framework of a voluntary commitment. These can be consultancy fees, training events (these, however, for whatever reason without entertainment costs, but with travel and accommodation costs), market research, sponsoring, donations, also donations in kind or research and development. In the case of the former, the amount of the donations is to be shown individually with name, address and LNR, i.e. the lifelong doctor’s number; in the case of research and development, it is to be published in summary form without mentioning the names. The whole thing also works across countries; the provision of the country in which the recipient’s main residence is located is valid in each case. Exclusively OTC-related donations do not have to be published. Similarly, so-called “joint events” without exchange of services do not have to be disclosed. Market research fees and expense allowances are of course also excluded. And last but not least, it is up to you to decide whether you report gross or net. As you can see, there are basic rules, but also many exceptions and special cases.
Transparency Code – This seems very complicated – does everyone have to participate?
For the members of the FSA e.V. as a member of EFPIA, the matter is clear, we have to do it. But the rest? And isn’t it a voluntary act? – No. Sooner or later there would have been or will be political pressure, the party “The Greens” have filed a motion for consultation in the Bundestag and the party “The Left” have jumped on this bandwagon just to be on the safe side. A voluntary act is certainly a suitable way of pre-empting a law. As far as voluntariness is concerned, the FSA e.V., in its function as a “self-control body” and “authoritative control and sanctioning body of the industry”, also wants to ensure transparency in the entire industry and, for safety’s sake, announces that “as a competition association, it will take action in civil court” against misconduct even by non-member companies. The sanctions can be fines of up to 400,000 € or even a public reprimand, i.e. display.
The Transparency Code therefore concerns everyone for the time being.
So what is to be done? Identify payments according to the rules outlined above, add them up and publish their names – that’s all. Unfortunately, it is not quite that simple in practice. Identifying the individual payments in the financial system or perhaps in the event system or perhaps at the agency that handles the processing, or in the congress system or or or will still work, but aggregation is somewhat more difficult. For each recipient, only the sum of the different types of services should be published. One could make it easy on oneself and let systems be systems, if the spellings of the names are different, then that’s just the way it is. It probably won’t work, and it won’t be long before someone threatens to impose sanctions if anyone looks at these publications. All right, then we’ll just buy some software. Aggregate Spend or Naya and we’ll be fine. That’s what we were promised by the manufacturers. The problem here, however, is that these tools also expect clean and complete data from all possible source systems. It can be assumed that the identification of the recipients works more intuitively with a data provider, but the payments themselves do not fit together in these systems if they are not fully integrated.
It is not new that these initiatives do not always make work easy in the countries, especially since they are based on the US Sunshine Act or the French Transparency Act, and that does not fit 100% with local needs, so compare them with these central initiatives and then build a solution that allows customer identification (e.g. via a customer master or as in the case of the French Transparency Act). (e.g. via a customer master or whatever you want to call such a customer mapping) and payment flows in a suitable form (could be commodity groups in the ERP system). In the case of any co-promotions, also agree on and store a distribution key, and of course do the whole thing quickly now, as the obligation to keep records already begins on 1.1.15. You can still correct everything manually if it is not implemented systemically by January, but it would be a considerable effort. So implement it by the end of the year, then design a solution for the presentation via the corporate website, which still has time until 2016 – work done.
It is not new that these initiatives do not always make work easy in the countries, especially since they are based on the US Sunshine Act or the French Transparency Act, and that does not fit 100% with local needs, so align with these central initiatives and then build a solution that can store customer identification (e.g. via a customer master or whatever you want to call such a mapping) and payment flows in a suitable form (could be commodity groups in the ERP system). (e.g. via a customer master or whatever you want to call such a customer mapping) and payment flows in a suitable form (could be commodity groups in the ERP system). In the case of any co-promotions, also agree on and store a distribution key, and of course do the whole thing quickly now, as the obligation to keep records already begins on 1.1.15. You can still correct everything manually if it is not implemented systemically by January, but it would be a considerable effort. So implement it by the end of the year, then design a solution for the presentation via the corporate website, which still has time until 2016 – work done.
Not quite: something is to be published about individuals, and after all, they enjoy data protection. Then you just collect their declarations and publish them. Although the Medical Council promised full support at its meeting in May and therefore instructed the Medical Association to present results by the next meeting, the topic was no longer on the agenda of the follow-up meeting. It may be that this is connected to the issue of a renewal of the medical professional law, for which at least motions for an amendment of the model professional code were submitted, which were referred to the Executive Board.
So data protection: another preliminary remark on this: in general, a distinction has to be made whether we are talking about the publication of payments to legal entities or natural persons. With legal persons this is simple, as it is not necessary, with natural persons it is more complicated, here it depends on the size of the practice and the recipient accounts, but it would be too much to go into all the details at this point. Either way, this is a point that needs to be fully examined. For the sake of simplicity, let’s assume the normal case of the individual doctor. As an individual payee, he or she of course still has the right to refuse the publication of his or her data. And if you read the law correctly, he or she can do so whenever he or she wants and thus also specify validity periods himself or herself. This means, however, that a solution and also an operating model regarding the period of validity, updating and speed of updating and general maintenance and storage must be considered and implemented. Especially since more far-reaching measures may also depend on this.
Currently, FSA e.V. is considering enacting a so-called cooperation ban for those professional groups that do not give their consent. A first legal opinion in this regard has not found any mandatory violations of cartel law as well as possible violations of the general prohibition of tying, which in itself is not surprising, since the FSA commissioned this opinion. However, whether such a ban on cooperation is really fruitful may be doubted, because let’s think about it, haven’t the typical payment recipients always been opinion leaders or important multipliers? And do we want to do without this clientele? It is possible that the companies and their associations will have to make some adjustments.
At the moment, however, this extension of the code does not yet exist, so the following applies: The presentation of payments for which there is no valid data protection declaration should be displayed in their entirety as an aggregation. This can be quite interesting if the payments not covered by data protection declarations will subsequently show the highest sum by far as an aggregation. Of course, it is not yet confirmed that this will happen, but it is possible.
Currently, the FSA’s latest publication is trying to convince those affected. Quote: “we have given a lot of thought to how we can further support you in convincing the doctors you need.”
Transparency creates trust and combats mistrust.
Why should I give my consent for the publication of my personal data?
- Cooperation between pharmaceutical companies and healthcare professionals is important and necessary.
- It serves the well-being of patients and the continuous improvement of their medical care.
- For this purpose, there are clear guidelines, laws and codes that clearly regulate the cooperation for both sides.
- Transparency in cooperation avoids the appearance of conflicts of interest in the first place.
A final note on the point of the operating model: Who will take care of data protection declarations on an ongoing basis? Who will keep data clean? Is there already a clearing office? Is it adequately staffed? Just one figure: in the audits carried out so far, we have seen a proportion of 10% to 15% of customer data records that have to be processed manually in order to ensure mapping between the systems. In the case in question, with a volume of more than 40,000 transactions per year, this means about 5,000 customer records that would at least have to be manually checked or corrected. Someone will also have to take care of this maintenance – the key word here was: organisational equipment and embedding.
But perhaps we should also take another look at the doctors’ perspective and their risks. Even here, the FSA showed understanding and answered the question about individual benefits with the messages earlier. The second point, that doctors would be afraid of being pilloried, could not be answered by the association yet. But this point seems very important to me. Especially in times of increasing social media activities, the number and degree of aggression of bashing activities is also increasing. Let us think for a moment how a patient who was dissatisfied with a certain therapy might react? He seeks out the manufacturer of the drug of his therapy, seeks out the doctor and then posts his view of things. Yes, the doctor is prescribing us the wrong medication, he has received so much money from company X for it. It also looks credible, because he can now seemingly back up his previously vague assumption with reality based on figures. Of course, this is only a possible scenario, but with the increasing number of evaluation portals and other possibilities for dissemination, it seems worth considering these unforeseeable and incalculable consequences. If, in reality, the first cases become public and are reported in the media, then at the latest some people will start to wonder. Whether every doctor will then permanently give his or her consent may at least be doubted. There as there, it is a question of reputation and the representatives of both groups, i.e. their associations, would be well advised to really pull together here.
Transparency Code – So what will the result look like?
The representatives of the pharmaceutical industry will say: “our members have done everything to be 100% transparent” and thus rightly claim increased reputation for their clientele, who bear this measure at no inconsiderable expense. The doctors’ representatives will wash their hands of it, even if not all of them followed their recommendations. The association would have supported it, but if there are dissenters, nothing can be done. Politicians will pat themselves on the back and present themselves as the initiators of the initiative for having brought more light into this corrupt swamp. And the patient? He is left alone anyway, since he has no idea from which company the doctor he trusts has received anything at all and cannot search all the manufacturers. And via the data protection joker, which the doctor can or perhaps must use differently from company to company, he or she may get no information at all or only extremely vague information about his or her doctor.
Back to the initial question: Benefit for whom?
The doctors who already do without any benefits, for them nothing will change, for the others a lot depends on whether they allow publication or not. It is doubtful whether non-publication and the potential mistrust that goes with it will have a negative impact on the typical doctor-patient relationship.
Patients and the public: Once again, a quote from the FSA: “With the publication of benefits from pharmaceutical companies to healthcare professionals, patients have the opportunity to convince themselves of the ethically impeccable cooperation. And: In future, everyone will be able to understand why which doctor has entered into a working relationship with which company. Aha – on a sum level as an aggregation per payment type?
The patient can inform himself, but he has to do this for each manufacturer and may only see a sum without being able to understand the details behind it. Does the patient benefit from this? As long as not everything is published and as long as the sums of all payments per recipient are not shown across the companies, he will not be able to do anything with this information.
A small remark on this: For this scenario, however, companies will be found that offer this service, possibly the same companies that already helped with the implementation of the Code and the design of the solutions.
Pharmaceutical companies have the opportunity to better understand their processes and procedures and then make systemic, as well as operational, improvements. Just think about identification of invoicing parties or data clearing in the context of master data maintenance or data exchange with agencies and event managers. With all these cost-intensive measures, a hopefully improved public image is at least a positive side effect to be expected. Involving corporate communications can certainly also be very helpful at this point. What remains, however, is to see this as an opportunity to optimise your processes.
Thomas Wagner, consultant at MMM Consulting GmbH in Berlin, has held various national and international management and advisory positions in leading pharmaceutical companies since 1999.