The Spanish pharmaceutical industry has become a model of disclosure. By setting clear rules, ensuring all parties were aware of their responsibilities and, where necessary, introducing sanctions for non-compliance, Farmaindustria oversaw a culture change in how companies collaborate with healthcare professionals and healthcare organisations.

However, this is not an overnight success story. The work began over twenty years ago when our industry embarked on a new era of gradual transformation, punctuated by several landmark changes to how we work. In the process, Spain’s experience helped to feed into the development of the EFPIA Code which, in turn, provided valuable momentum to our efforts at national level.

The first step came in 2004 when companies began sharing information with Farmaindustria about their collaborations with scientific and professional meetings. Sponsors notified us ten business days in advance of these events, marking the first step towards greater transparency.

Two years later, in 2006, we took an even bigger leap forward by launching a public event database. This allowed companies to get advance approval for their potential collaboration or sponsorship with scientific congresses organised by third parties. The tool was used as a model for the implementation and development of EFPIA’s e4ethics events database.

This expanded in 2008 to include information on sponsorship of market research studies. Then, in 2010, the database grew again, to cover the organisation or sponsorship of projects that require services provided by healthcare professionals or healthcare organisations.

Complying with the Code

Securing industry-wide buy-in is crucial to sustaining change. We knew from the beginning that all members would need to sign up and follow through on their commitments, or trust in the system would not last. That is why we established three ‘control bodies’ responsible for ensuring the effective application of the Code of Practice. Crucially, the system includes a mechanism for resolving disputes.

The first of these oversight bodies is the Code of Practice Surveillance Unit which is tasked with ‘active monitoring the compliance of the Code’. The second, the Code of Practice Committee, mediates between the parties involved in a dispute concerning matters subject to the Code. The third is the Jury of the Association for Self-Regulation of Commercial Communications. Its main function is to resolve those complaints where a mediation agreement is not reached.

Data protection and disclosure

We were, always, mindful of balancing our disclosure goals with data protection rights. It was also crucial to begin disclosing payments and transfers of value to healthcare professionals and healthcare organisations on an individual basis.

Progress was slow at first. The disclosure initiative began in 2013, with the first transfers of value published in 2016, based on 2015 data. In the beginning, the level of transparency was approximately 10%, so we knew a more robust approach was needed.

We explained our model of self-regulation to the Spanish Data Protection Agency which studied our proposal closely. The Agency, on 22 April 2016, stated that healthcare professionals’ consent is not necessary for the disclosure, on an individual basis, of the transfers of value made to healthcare professionals. They concluded that that individual interest did not prevail over the public interest.

Instead, companies could advise a healthcare professional in advance of collaboration that transfers of value would be published. If the healthcare professional did not agree, the collaboration did not take place.

Since then, in Spain, 100% of transfers of value to healthcare professionals have been published by name and surname, with full individual identification. The support of data protection authorities has been a milestone in Spain and is the first self-regulation model recognised for complying with current legislation, setting an example for other sectors.

Following the Spanish Data Protection Agency’s decision, all transfers of value made from January 2017 have been published on an individual basis. The publication had a notable impact in the media, and since then, with the publication at the end of June, this initiative has become standardised. It is assumed that the industry fulfils its commitments, which has resulted in generating trust and credibility in how the industry interacts with very important stakeholders.

Updates to the Code

Disclosure remains a continuing story of incremental change. As an industry ‒ in Spain and at European level through EFPIA ‒ the implementation of transparency measures evolves in response to the needs of companies and partners.

The 2021 version of the Spanish Code has two additions that have further strengthened how we operate. It includes practical guidance for communication and relations with the media concerning prescription-only medicines. And guidance concerning services provided by healthcare professionals or by healthcare organisations. These add clarity for all parties on how the Code should work in practice.

Spanish lessons

As we reflect on two decades of enhancing transparency in Spain, and ten years since EFPIA led a Europe-wide disclosure initiative, we celebrate what has been achieved and look to continue improving how we operate. In the process, we are pleased to share our experience with colleagues across Europe who would like to study our story. And we will learn from our peers as we shape a more transparent future for our industry.

At every point in this journey, we remind ourselves that disclosure is essential to trust ‒ and that trust is essential to better healthcare and better business.