מבזק מדעי החיים | יוני 2018
Ministry of Health regulations – Commercial Engagements by Healthcare Institutions
Health Institutions Commercial Engagements
On June 18, 2018, the Israeli Ministry of Health ("MOH") issued Directive 11/2018 (the "Directive"). The Directive applies to all public and private healthcare institutions operating under an MOH license with respect to their engagements with commercial activities regarding activities in Israel or outside of Israel. The Directive will enter into effect on November 1, 2018. The following are the major matters covered by the Directive:
Establishment of Institutional and Supreme Committees:
The Directive provides that each healthcare institution will establish an internal committee the authority of which will be to examine and approve the institute's own engagements with commercial entities. Additionally, the MOH will establish a supreme committee, which will be responsible to review the institutional committees’ decisions and to propose policies for commercial engagements between healthcare institutes and commercial companies.
Clinical Trials and Research:
The Directive provides that clinical trials or research engagements with commercial entities must be approved by the MOH’s Supreme Committee according to the procedures set forth in the Directive.
The commercial entity will typically be the one responsible for funding the tested product. Additionally the trial's or research budgets must include breakdown of the expected expenses.
The Directive reiterates prior regulations with respect to publication of the clinical trial results.
Funding local conferences:
The Directive provides that commercial entities may fund conferences conducted by healthcare institutes, so long as such conferences are not for marketing purposes, and do not include any activities that are not related to the conference’s professional topics.
The Directive further provides that regulatory bodies and MOH units must acquire prior approval from the Supreme Committee, in order to receive funding for holding conferences.
The Directive provides the guidelines for participation of healthcare institutes' personnel in conferences organized by commercial entities. .
Funding Healthcare Institutes' Personnel Traveling Abroad:
The Directive provides that a commercial company may not fund the traveling abroad of a specific healthcare institution employee. Nevertheless, a commercial entity may provide the institution with an overall budget for travel expenses for conferences so long as: (1) the institution is the entity that elects the employee who will participate in the conference; (2) the elected employee has no affiliation with the commercial entity; (3) the elected employee has no influence on the institution's purchasing decisions, and (4) the conference is not for marketing purposes. If the healthcare institution manager wishes to approve a request that does not meet these conditions, he or she may apply to the supreme committee for approval.
The Directive further provides that it is forbidden to receive funds from a commercial entity for the purpose of traveling to evaluate the purchase of equipment.
Compensation to Healthcare Institutes' Personnel
The Directive stipulates that any work performed by a healthcare institution employee, and paid for by an external company, must be first approved by the institution's General Manager. Such approval may only be granted upon compliance with all applicable regulations, but may not be provided to an employee that has a relationship with the external company in his capacity as an employee of the institution. Furthermore, any paid consultation of an institution employee to a commercial entity, or a lecture by such employee in a conference organized or funded by a commercial entity, will be subject to the approval of the Institutional Committee.
Marketing of Drugs, Medical Devices and Food
The Directive provides that medical health products’ sales representatives may operate within a healthcare institution only after they have obtained a personal Authorized Representative Certificate from the institute (the "Certificate"). The Certificate will be issued only if the sales representative has sufficient scientific knowledge, with respect to the promoted products, and he or she has passed an ethics training course.
The Directive further stipulates, that a healthcare institute may not accept or request from the sales representatives any samples, other than for demonstration purposes, through the institution purchasing department, in advance and in writing.
The Directive further states that conducting personal meetings with sales representatives, or receiving any benefits from the sales representatives are prohibited. The sales representatives are required under the Directive to provide the healthcare institution a monthly report detailing the meetings conducted by the sales representatives in the institute.
For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com) or Adv. Tami Fishman, partner (Tamif@gkh-law.com)
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This alert is prepared as an informational service to clients and colleagues of Gross, Kleinhendler, Hodak, Halevy, Greenberg, Shenhav & Co. (GKH) and the information presented is not intended to provide legal opinions or advice. Readers should seek professional legal advice regarding the matters about which they are particularly concerned.