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Compliance as a strategy for sustainability and viability of the pharmaceutical and biomedical sector

| Events | Corporate Compliance

Experts Meeting in Pharmaceutical Compliance of Andersen Tax & Legal, Farmaforum and IQS in Barcelona

Compliance procedures are a necessary tool for prevention, supervision and control in extremely regulated sectors, such as the biomedical sector. This is due both to their high degree of natural complexity and to the regulatory burden they entail, especially in relation to prescription medicines. This need is now also a competitive and differentiating resource. It is an indicator of the good management of the company and its administrative body, which ensures compliance with cross-sectoral legislation and all internal company regulations (policies, protocols, codes of ethics, codes of conduct, etc.).

The Pharmaceutical Industry National Business Association, Farmaindustria, adopted in 1991 the European Code of Good Practice for the Promotion of Medicines, approved by the European Federation of Pharmaceutical Associations and Industry. This code has been regularly revised to adapt to the new needs of the sector. Thus a new system of self-regulation of the pharmaceutical industry emerged.

The associated laboratories compliance  with the Code is supervised by the Deontological Supervision Unit (USD). The USD acts, by delegation from Farmaindustria's governing bodies, as the orchestrator of the sector's compliance management and as a facilitator in the relationship with healthcare professionals, healthcare organisations and patient organisations.

Under the title Pharmaceutical Compliance and, due to the growing interest in companies in the pharmaceutical sector for aspects related to the concept of compliance and the need to know in depth, both the legal framework of application and the implementation and monitoring of it, a meeting of professionals was held at IQS on 13 July. The meeting was organized by IQS Executive Education, in coordination with FarmaFórum Formación and Andersen Tax & Legal and was attended by more than 70 attendees.

The event was attended by expert professionals and leaders in the world of compliance: José Zamarriego, USD Director and expert in self-regulation, Ana Bayó, Menarini Group Legal and Compliance Director for Spain and Latin America, Anna Morell, Ferrer Corporate Compliance officer, Beatriz Artalejo, Technical Director of IQS Tech Transfer with extensive experience in the pharmaceutical industry and José Ignacio Olleros, partner of Andersen Tax & Legal, who moderated the debate.

The session began with a presentation by Jose Zamarriego, who initially made an in-depth analysis of the evolution of the pharmaceutical sector in aspects of self-regulation in the last fifteen years. Due to the evolution of the pharmaceutical market for prescription drugs, the need to verify that the pharmaceutical industry complies with current legislation on the promotion of prescription drugs was recognized. Thus, in 2002, a Deontological Commission and a Self-Control Jury were created within Farmaindustia. Subsequently, in 2004, the USD was created to actively monitor compliance with the Code and the unique and unequivocal behaviour of all the laboratories that are members of Farmaindustria and those that voluntarily adhere to the self-regulation system. In the words of Zamarriego, "Compliance is synonymous with sustainability and transparency, as a guarantee for the future".

He also highlighted that the self-regulation system created is working in Spain. Mainly due to its preventive nature and with the awareness of witnessing a real change of perspective, it has managed to make public, for each of the laboratories, the data related to the transfer of value to health professionals and organizations in a very general way and the collaborations with patient organizations. In June 2018, all the value transfers made to health professionals and organisations in the laboratories associated with Farmaindustria during 2017 were made public.

After the presentation, a very dynamic debate began between the speakers and the audience, focused on two fundamental questions. The first question from the moderator, José Ignacio Olleros, on "How to create a culture of compliance in the company", the speakers agreed on the need to have two critical elements: time and management support in the application of compliance procedures. Success can only be achieved if the entire company shares the values in an ethical environment, in which the support of management acts as a multiplier. Adequate internal regulations, a culture of communication, responsibility and proximity, specific and practical training, were some of the elements listed to ensure true transparency in the management of the company: "Supporting good practices together", "Coherence from above, co-responsibility from below", "Self-regulation is a question of knowing where we are going", were some of the quotes taken from the experts.

The moderator's next question on "How to monitor and accredit the correct functioning of the compliance program", the answers of the speakers focused on the implementation of internal audits and the creation of monitoring tools, the availability of risk maps, internal control policies, procedures, etc. "It is not enough to have a compliance program, it is essential to ensure compliance with the commitment of all.

To conclude, José Ignacio Olleros announced that IQS Executive Education is launching a training course for `Compliance Officers in the Pharmaceutical and Allied Industry', in collaboration with FarmaFórum Formacion and Andersen Tax & Legal, which will start next September. The course, led by Rocío Gil Robles, head of the Compliance Department at Andersen Tax & Legal, is aimed at professionals in the health care industry who are developing or wish to develop the role of Compliance Officer in this sector.

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