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On 27 November 2013, the Association of Voluntary Self-Control of the Pharmaceutical Industry (Verein Freiwillige Selbstkontrolle für die Arzneimittelindustrie – FSA) General Assembly adopted a Code of Transparency for interaction with Healthcare Professionals and Healthcare Organisations (the "Transparency Code").¹ The Transparency Code is now approved by the German Federal Cartel Office as a competition rule.

Currently, under German law, payments by pharmaceutical companies to healthcare professionals do not trigger reporting obligations of the pharmaceutical company. Instead, certain activities in respect of payments to healthcare professionals are legally prohibited. Moreover, in case of a breach of the provisions there are corresponding penalties in place. However, whether or not a practice is in compliance with the applicable laws and professional standards, the pharmaceutical company does not have a reporting obligation in this sense, with only few exceptions:

• in cases of non-interventional studies with authorised medicinal products, the pharmaceutical agent must notify the study to certain authorities including the type and amount of the remuneration paid to doctors in so far as participating doctors provide benefits which are reimbursable by the statutory health insurance;
• companies must publish the granting of certain donations or other unilateral benefits to institutions, organisations or associations whose members are healthcare professionals; and
• companies must also make available to the public a list of patient organisations that they support financially or that receive significant indirect or non-financial benefits including the total amount of monetary benefits and/or donations in kind per calendar year and patient organisation.

With the Transparency Code, all future payments in kind by the pharmaceutical industry to physicians and further healthcare professionals, along with organisations in the healthcare field, shall be made public. However, it is important to note that the Transparency Code is only binding for the members of the FSA. According to the FSA, the members believe that working relationships between healthcare professionals and the pharmaceutical industry must be adequately and fairly remunerated by the industry.² At the same time it is important to avoid conflicts of interest that may arise from the interaction of pharmaceutical companies with physicians and other healthcare professionals. To avoid such conflicts of interest, the FSA has already adopted a code for the collaboration of the pharmaceutical industry with doctors, pharmacists and other healthcare professionals as well as guidelines relating to the code, in order to base collaborations on high ethical standards. As a result of this, the self-regulation of the industry has, in the opinion of the FSA, achieved a high level of success which must be further promoted to ensure that the steadily rising expectations of society for transparency in such interactions can be met.

The members of the FSA have agreed to be bound by the new Transparency Code in collaboration with cooperation partners in the healthcare field. By doing so, in the future they will be required to disclose the names of physicians and other members of the healthcare field with whom they are collaborating and the nature of the relationship. This binding requirement for FSA members encompasses payments of consulting fees, the rendering of services of the member company or services of hired agencies. Compliance with the Transparency Code will be monitored by the FSA arbitration panels and sanctioned in case of violations. From 2015, the FSA member companies will be documenting all direct and indirect payments and benefits in kind made to healthcare professionals or organisations of the healthcare system from the areas of research and development, donations and payments, sponsoring and other forms of financial support, invitations to advanced training events, as well as service and consulting fees. For the first time in 2016, the benefits in kind made by FSA member companies to healthcare professionals will be published, based on the year 2015. The disclosures will be made available on the websites of the member companies and updated annually.

In addition to the Transparency Code, a fundamental change in the Healthcare Professionals Code was promulgated at the FSA General Assembly. In the future, gifts of any kind to healthcare professionals will be prohibited.¹ Among other things, this applies to inexpensive promotional items such as pens or notepads. The new rule came into effect on 1 July 2014.

Outlook

For the pharmaceutical industry, the topic "transparency" will remain controversial. With the approval of the EMA policy on publication of clinical trial data by the Management Board the EMA will in future be allowed to proactively publish clinical trial data that is submitted as part of marketing authorisation applications, after grant of the authorisation. Nevertheless, the concerns about the proactive publication in regard to the protection of commercially confidential information remain. However, the decision of the European Union General Court in the case InterMune UK and Others v EMA may clarify the situation. A careful monitoring of these proceedings by industry seems to be advisable. Besides, the pressure on pharmaceutical companies in regard to transparency and the publication of data grows, especially because some pharmaceutical industry associations have recently taken transparency initiatives.

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