In more detail
A key point of the Act that may be of interest to the pharmaceutical industry is the set of conflict of interest rules to be applicable to physicians that want to engage in activities (e.g., private practice or other professional services) beyond the healthcare service relationship regulated by the Act.
The Act requires the prior authorization of a body to be designated by the Government for any further employment relationship or remunerated activity of physicians with the exception of scientific, educational, artistic, readership, editorial work or intellectual activity falling under legal protection.
This provision may have an impact on professional services agreements that pharmaceutical companies conclude with HCPs for advisory, speaker or other services.
Companies should assess if the professional services to be provided by the HCPs fall under the above statutory exceptions. If the services do not fall under any of the above exceptions, the physician will have to obtain the prior authorization of a Governmental body.
The prior authorization of the body to be designated by the Government will always be necessary in case the duration of the professional services mandated by a pharmaceutical company overlaps with the working time of the physician under the healthcare service relationship regulated by the Act.
Further, physicians may not conduct healthcare activity (beyond their statutory healthcare service relationship) at the seat or premises of the healthcare service provider employing them. This conflict of interest provision may impact clinical trial contracts as investigators usually conduct clinical trial activities at their own institutions which also often have a contract with the sponsor for conducting the clinical trial.
In case of failure to comply with the above provisions of the Act, the healthcare service relationship of the physician shall be terminated with immediate effect.
We await the implementing decrees of the Act and hope they will contain guidance on the interpretation of the above provisions of the Act as well.