Changes affecting pharmaceutical companies

An important year for the healthcare sector in Poland has just ended. It was the first year during which selected pharmaceutical companies began to collect data concerning transfers of value to healthcare professionals (”HCP”) and healthcare organizations (“HCO”) in the course of their operations. These companies are signatories of the Disclosure Code, which is a part of pan-European initiative launched by EFPIA (European Federation of Pharmaceutical Industries and Associations). In Poland, the Code has been adopted as an internal regulation by the pharmaceutical companies being members of the Employers’ Association of Innovative Pharmaceutical Companies INFARMA.

The signatories of the Disclosure Code collect data concerning the value of payments made to HCPs and HCOs. In compliance with the Code, pharmaceutical companies will have published data for 2015 on their websites by 30 June 2016 with the knowledge and at the consent of HCPs and HCOs.

What is the importance of the Disclosure Code for the pharmaceutical industry, medical community and patients? Will it meet the requirements defined for it?

The idea behind the Disclosure Code

The Code was established at the initiative of pharmaceutical companies themselves to highlight the importance of transparency of the relationships built and maintained with HCPs and HCOs. Due to the specific nature of the business, interactions between pharmaceutical companies and the medical community are inevitable in numerous fields, such as clinical trials. For all the stakeholders, including the patients, enhanced transparency should translate into strengthened confidence in the healthcare system in addition to enabling reliable and unbiased evaluation of the relationships with the physician community if necessary.

Voluntary participation is the key principle underlying the Code, which is not part of the legal system but self-regulation in the healthcare community. At their own discretion, HCPs will take decisions on disclosure of information regarding the transfers of value they receive along with the receiver’s name to the public. The first publication of data may be a test of whether the idea of the Code has been interpreted properly and whether implementation of the practice of making transfers of value between pharmaceutical companies and the medical community will increase transparency and enhance confidence in the relationships between those companies and the physician community.

US Sunshine Act

It should be emphasized here that the United States have adopted the Physician Payments Sunshine Act (the “Sunshine Act”).

As opposed to the Disclosure Code, which is based on the principle of voluntary participation, the Sunshine Act is a legal regulation imposing the obligation to gather information regarding financial transactions between the medial business and the physician community.

Additionally, pharmaceutical companies in the United States do not publish the relevant data themselves. Instead, they submit such information to the Centers for Medicare & Medicaid Services (CMS), which subsequently disclose it to the public.

We have already discussed the Sunshine Act at:

Will European healthcare compliance requirements follow in Sunshine Act’s footsteps?




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