BMI SYSTEM participated in the 2017 Global MedTech Compliance Conference (GMTCC) which took place in Amsterdam on the 3-4 May 2017.
This year the conference addressed 3 main topics:
- how the shift to value may impact compliance
- what to do with the multiplication of rules
- the role of compliance in handling privacy and big data
One of the first speeches was made by the Director of Pharmaceutical Affairs & Medical Technology in the Dutch Ministry of Health, who presented the compliance approach of the Dutch government. He highlighted that the Dutch system is based on a combined approach between self-regulation and legislation. As an example regarding transparency rules:
- The healthcare transparency register is derived from the self-regulation
- The prevention of unwanted influence is ruled by legislation. These rules ban all advantages to HCPs except:
- Reasonable hospitality
- Small gifts
- Training and education
- Negotiation during call for tenders
Since 2007, the self-regulation system has been built on a code of conduct issued from the GMA foundation for the medical device sector with strong political support from the Dutch government.
On the other hand, the regulation applies to the interactions between life sciences companies and HCPs, HCOs and associations including the definition of fair market values for consultancies fees.
Asked if a register for grants provided to associations will be created, the Director of Pharmaceutical Affairs & Medical Technology answered that no such project exists at this time.
Another interesting topic addressed was about the value based care approach. This represents a profound transformational shift as the concept of value gains traction in healthcare systems around the world. For companies, the implications are profound, and these new commercial models present opportunities but also significant challenges in the transition from a product-driven industry to one focused on services.
The aim of this concept is to closely link the use (and the reimbursement of healthcare products) to the outcome of the patient.
The value based care approach is quite an old idea (about 10 years old) and some issues regarding this approach were raised by the speakers:
- There is a need to define the meaning of “value”
- There are still challenges for healthcare authorities to make a direct link between this new model, the price and the level of reimbursement
- So far, models put in place with this approach have been limited to pilot programs
An indirect consequence of this approach is the data privacy challenge: assessing the care value of a medical device usually means analysing a large quantity of patient data, and as a consequence, to take the requirements of the new European General Data Protection Regulation into account.
As a conclusion for this topic, all the speakers agreed on the fact that the cost of care is increasing in an unsustainable manner, and that the value based care approach could be part of the solution.
Data privacy was the third main topic discussed during this conference since the Medtech industry is strongly impacted by the new European regulation for various reasons:
- They manage a lot of personal data
- Medical devices include more and more software, not to speak of the pure medical mobile applications
The main provisions of this regulation were presented with a stress on some provisions such as:
- The portability of personal data which is a challenge from an IT perspective and a competitive perspective as well
- By default, data privacy applies to software and to any kind of project. It requires documented proof that data privacy requirements were taken into account throughout a project. This requirement applies untill the end of the process (i.e. the destruction of the medical device by the end-user, usually the hospital: how to be sure that the personal data stored in the medical device will no longer be accessible?)
- The process to provide access to data upon request
A lot of questions still remain for the implementation of this regulation, such as:
- transfer of data
The question of a European Lifesciences Industry code was addressed during a last session involving 4 associations:
- MedTech Europe,
- the COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry),
- Medicines for Europe (association which represents the European generic, biosimilar and valued added pharmaceutical industries)
- and the EFPIA.
The conclusion of this roundtable was that each industry (pharmaceutical industry, medical device industry, industry of medical device for diagnostics, have different risks). Thus a common code for life sciences industries could not go into detail or it may miss specific risks and roles of each industry. So such a code would have to address only the main principles.
MedTech Europe Code of Ethical Business Practice and Indirect Sponsorship
Member Companies had to transpose the Code internally between 1 January 2016 and 31 December 2016 at the latest. No later than 1 January 2018, Member Companies shall cease direct financial and in kind support to individual HCPs to cover the costs of their attendance at Third Party Organised Educational Events. To avoid any doubt, the provisions linked to the Transition Period will be transposed as provided in the Code.
As soon as a Member Company transposes the Code internally it shall immediately notify the MedTech Europe Secretariat, specifying the date on which such transposition became effective.
As soon as a Member Company ceases direct financial and in kind support to individual HCPs to cover the cost of their attendance at Third Party Organised Educational Events, it shall immediately notify the MedTech Europe Secretariat, specifying the date on which such cessation became effective.
The MedTech Europe Secretariat shall appropriately document and maintain records of all such notifications.