The Portuguese Ministry of Health issued a new law, (Decree-Law 5/2017), on January 6th 2017, which creates additional reporting obligations for Life Sciences companies and further promotes transparency in promotional and sponsorship activities in Portugal.
Benefits and Sponsorships to National Health Service Institutions Prohibited
One of the most significant aspects of this new legislation is a broad prohibition on departments and bodies of the National Health Service (the “SNS”) from receiving, directly or indirectly, “benefits” from companies that supply “goods and services”. These goods and services include medicines, medical devices and other healthcare technology, IT equipment and services and other associated equipment and services. There is, however, an exception where it can be proven that the benefit does not compromise the impartiality and independence of the receiving SNS entity. Qualification under this exception is subject to authorization by the Ministry of Health. The law also prohibits manufacturers, distributors or sellers of medicine or medical devices from sponsoring scientific-related promotional activities located at SNS-related departments/entities and the Ministry of Health. However, the law does not prohibit sales representatives and MSLs from visiting SNS-related entities.
Additionally, the law provides a broad definition of “benefit”, meaning “any advantage, value, asset or right measurable in money, regardless of how it is given, whether it is a bonus, sponsorship, subsidy, fee, grant or other,” that is provided to a healthcare organization (HCO) or a healthcare professional (HCP).
The new law also extends the scope of the current transparency requirements, which initially only targeted pharmaceutical companies but now include medical device companies as well. This expanded scope is motivated by the significant growth of the medical device market in Portugal over the past few years (now accounting for approximately €700 million in SNS spending) as well as international norms (i.e. MedTech Europe’s Code of Ethical Business Practice).
Under this new regime, all Life Sciences companies (pharmaceutical and medical device) must disclose benefits provided to HCPs and HCOs in the transparency portal of Portugal’s drug and health products regulatory agency, Infarmed. This disclosure must be made within 30 days of an HCP/O’s receipt of a benefit. Additionally, the new law eliminates the double disclosure requirement, meaning Life Sciences companies are only required to disclose the benefit, and HCP/Os must simply validate the receipt of the benefit. Thus HCP/Os are no longer required to disclose the receipt of benefits.
Lastly, the new law clarifies which entities are “beneficiaries” where there are third parties involved. For example, if a Life Sciences company provides a benefit to an HCO but an HCP is the ultimate beneficiary, the Life Sciences company must identify the HCO as a beneficiary and the HCP as the ultimate beneficiary.
The law will be go into effect on February 5th, 2017.
For detailed information about how this law may affect your compliance activities, please contact Polaris’ subject matter experts.