After a few breakthroughs and setbacks on who should report, what, how and when, the rules and obligations seem to be less obscure.
Transparency on earnings was one of the new obligations brought with the last amendment to the Medicinal Products Act through the Law-Decree n.º 20/2013, of February, 14.
What should be reported?
Any subsidy, sponsorship, donation or any other value, asset or right assessable in money with a value of over € 25, pursuant to the Ministry of Health Order n.º 4138/2013 of 20 March, granted or received.
Trade discounts, rebates and other similar items given to the pharmacies are not subject to report.
Who should report?
Pharmaceutical companies that, directly or through an intermediary, grant or give such subsidy, amount or similar to:
- medical associations or any other type of entity, whatever its nature or form, representative of a particular group of patients and
- scientific or clinical trials company, association or society.
In case there are several beneficiaries, even if it is for the same promotional event, the pharmaceutical company should make a report for each beneficiary.
Within the Pharmaceutical companies, the report shall distinguish whether the subsidy, amount or similar is granted or given by the holder of the marketing authorisation or by the local representative in Portugal of the foreign marketing authorisation holder.
Notwithstanding the above, pharmaceutical companies do not need to report:
- Registration of health professionals in conferences, scientific meetings, seminars, etc.;
- Accommodation and related expenses incurred by the health professionals with such conferences, scientific meetings, seminars, etc.;
- Free samples of medicinal products.
This exemption applies because the pharmaceutical companies already need to keep the necessary documentation and records of such practices for 5 years for the purpose of verifying compliance with the law by the supervisory authorities.
On the contrary, physicians and other health professionals must always report any sponsorship, donations, gifts or any other value received by the pharmaceutical industry, except the free samples of medicinal products.
Thus, as far as earnings are concerned, anyone who receives such subsidy, amount or similar must report, including:
- any association, or any type of entity, whatever its nature or form, representative of a particular group of patients;
- scientific or clinical trials company, association or society; or
- any other entity, natural (healthcare professionals, such as physicians, dentists, pharmacy technicians, nurses) or legal person (private or public).
To whom the report should be made?
INFARMED – National Authority of Medicines and Health Products, IP (“INFARMED”).
How should it be reported?
At the website of INFARMED through the Platform “Transparency and publicity” (http://placotrans.infarmed.pt/).
Moreover, any of the entities above refereed that receive earnings should also mention such subsidy, amount or similar in all documentation with public disclosure used in the scope of its activity.
When should it be reported?
The report obligation is effective since February 15 of 2013.
Reports should be made within 30 working days counting from the day the subsidy, amount or similar is granted or received, as applicable.
Unconstitutionality of article 159.º of the Medicinal Products Act
These new obligations are causing a lot of noise in the health sector, especially among the physicians. The Portuguese Medical Association (PMA) stated that the Platform is illegal because when the Law-Decree was published and already in force, the Platform had not been notified to the Portuguese Data Protection Authority as it should be once it processes personal data.
Furthermore, according to two legal opinions issued by the PMA, these new obligations conflict with the constitutional principle of presumption of innocence, as it may be considered, in practice, a way of obtaining evidence (by confession) of committing a crime of bribery or reception of undue advantage. Therefore, it is expected for the PMA to raise the question of unconstitutionality of these new obligations very soon.
Privacy and data protection
Meanwhile, INFARMED notified the Portuguese Data Protection Authority of the processing of personal data carried with the purpose of providing the abovementioned Platform.
Although silent about the questions raised by the PMA, the Portuguese Data Protection Authority registered the INFARMED’s processing on April 12, having considered that the data collected are adequate, necessary and not excessive, in relation to the purposes for which they are collected, with the exception of the tax payer number, because it shall only be collected for the processing of tax information, which is not the case.
The Portuguese Data Protection Authority also imposed INFARMED to implement new more effective mechanisms of authentication of the Platform users in order to increase the platform security.
Furthermore, the Portuguese Data Protection Authority also considered essential that INFARMED:
- carries out technical impact studies, in order to fully achieve its objectives without causing any violations of the fundamental rights of citizens (Privacy by Design); and
- develops audit mechanisms in order to ensure the traceability of access.
In addition the Portuguese Data Protection Authority also decided that as far as logs are concerned, they must be digitally signed in order to be considered valid.
Finally, the Portuguese Data Protection Authority also required INFARMED to develop an alarm system capable of detecting any misuses of the system.
Thus, the Platform although operational is under evolutionary maintenance.
Failure to comply with the report obligations, retention of supporting documentation, including action programs or events, gives rise to the following fines:
- from € 2.000 up to € 44.891,81 in case of legal persons;
- from € 2.000 up to € 3.740,98 in case of natural persons.
Moreover, the following additional sanctions may be imposed for up to 2 years:
- temporary prohibition of the exercise of the activity;
- prohibition on participating in public tenders;
- suspension of permits or licenses.