Although physician consent requirements are widespread across Europe, the fact is that different EU member countries have different rules surrounding the issue. Out of all, around 14 countries have a law or code in place, five countries (including France, Portugal, Romania, Netherlands, and Denmark) do not require consent, five countries (including Greece, Austria, Luxembourg, Hungary and Switzerland) deem it necessary for pharma companies to acquire consent from the HCO, four countries ‘recommend’ that pharma companies obtain consent, whereas eight countries don’t mention consent at all.
If anything, the applicability of consent requirements are somehow dependent on aspects like:
- The country in which the entity using the information is located and operational
- The intended use of acquired personal information
Apart from that, it is also necessary for consent to be collected not just for spend data that is meant for public publication, but that for spend data meant to be used for internal reporting, benchmarking, and analysis.
Given below are a few examples that present information about the ways in which countries and country pharmaceutical associations are dealing with consent-related issues:
Spain
In Spain, the ‘Datos Identificativos’, which is a unique number, is used to identify the HCP with the Documento Nacional de Identidad (DNI) for individuals, and companies are identified using the Certificado de Identificon Fiscal (CIF). When the spend report is published, privacy is maintained by anonymizing the number.
For this, the same encryption procedure is used as the one by tax authorities for partially masking the number (e.g. xxxx123xxxx).
United Kingdom
A model clause and guidance note have been provided by the Association of the British Pharmaceutical Industry (ABPI). The note is basically meant to be included in an agreement between pharma companies and HCPs and should be incorporate when HCP consent is being obtained for disclosure purposes.
However, what needs to be mentioned here is that using the model language is merely a suggestion and not a requirement, so pharma companies are allowed to make amendments to it.
Czech Republic
Based in the Czech Republic, the Association of Innovative Pharmaceutical Industry (AIFP) has taken a completely different approach to consent and the issues surrounding it. Pharma companies in the Czech Republic have been given the ability to use a legal dispensation, which would no longer deem it necessary for them to acquire consent from an HCP as long as an agreement is in place between the HCP and AIFP with a provision outlining that the processing of personal data is a requirement for the purposes of the agreement. As long as this agreement is obtained in writing, there is no longer for HCP consent to be obtained and hence, consent cannot be revoked.
Australia
In Australia, it is necessary for all reported payments and transfers of value to be in line with the Commonwealth Privacy Act 1988. For this reason, an onus has been placed by the authorities on the pharmaceutical industry, thereby deeming it necessary for them to establish a process for the attainment of consent. Under section 41.3.2, companies have to establish a proper mechanism through which they obtain informed consent before publishing information about their ToVs.
As a general rule in Europe, pharma companies must report HCP expenses in the aggregate in case an HCP does not consent to having his personal information disclosed at an individual level. The challenge, hence, lies in convincing HCPs to consent to the publication of their ToVs at an individual level.
