Posted on 25.08.2015
MedTech Europe, EDMA and Eucomed support transparency as a broad principle for all stakeholders. Within the healthcare sector, “transparency” may refer to a number of different issues, such as the following:
- Transparency laws/codes: Laws and/or ethical codes that require MedTech and/or pharmaceutical companies to publicly track and report transfers of value and other payments made to healthcare professionals (HCPs). Also referred to as “Sunshine”, “aggregated spend”, “disclosure obligations”. Examples: French & US Sunshine Laws, EFPIA Disclosure Code. MedTech Europe supports transparency and more specifically appropriate, effective, practical and reasonable disclosure of financial relationships and interactions between medtech companies and HCPs. Ethical standards are critical to ensuring appropriate collaboration between the IVD industry and HCPs. For more detailed information on the Eucomed position on transparency, click here.
- Transparency principle: Laws and/or ethical code provisions that require that medtech as well as pharmaceutical companies seek prior written notification or approval from the hospital administration, the HCP’s superior or other locally-designated competent authority (e.g. MDeon in Belgium; CNOM in France) to disclose the purpose and scope of the interaction between the company and the HCP.
- Clinical data/trial transparency: Public access to patient data gathered in clinical trials, mainly discussed within the pharmaceutical field, but not solely (e.g. clinical trial directive). This is linked to the public right to transparency regarding data used to approve new medicines, data protection and confidential/business secrets topics.
- Transparency of regulatory data by EU agencies: Different EU Regulatory Agencies (e.g. EMA, ECHA, EEA) have been discussing or even requesting greater openness information submitted by industry.
- Transparency directive 89/105/EEC: Transparency obligations for authorities in their pricing and reimbursement procedures for pharmaceutical products.
Outside healthcare, the concept of transparency is also used under the accounting and securities transparency requirements in Directive 2004/109/EC.