Ministry of Health Regulates Interactions with Pharmaceutical Companies: No Gifts or Benefits
- Mandating companies to provide accurate, documented pharmaceutical information free from misleading claims
- Restricting promotion to approved indications, dosages, age groups, and routes of administration
- Requiring a valid annual permit from the Pharmaceutical Inspection and Licensing Department to visit Ministry facilities
- Prohibiting companies and their representatives from attending technical committee deliberations or participating in voting
- Disclosing any conflicts of interest related to the company or the product under evaluation
The Minister of Health, Dr. Ahmed Al-Awadi, issued a ministerial decision regarding the regulations and principles governing drug and medical product promotion, as well as the management of interactions with company representatives at Ministry facilities, emphasizing information reliability and prohibiting the acceptance of gifts and personal benefits.
The decision defined the scope of promotion to be limited to locally approved indications, dosages, age groups, and routes of administration, banning off-label promotion within Ministry facilities or among healthcare providers. It also regulated interactions with unregistered or unapproved drugs in accordance with specified official regulatory and scientific channels.
Regarding professional visits, the decision required company representatives to hold a valid, personal, non-transferable permit issued by the Pharmaceutical Inspection and Licensing Department, valid for no more than one year and renewable.
The decision also specified the procedure for company representatives visiting Ministry facilities, requiring prior appointment and approval from the competent authority. Visits must take place in designated meeting or medical education areas and are prohibited during direct patient care, when doctors are in transit, or during pharmacy operations.
Concerning technical committees responsible for evaluating or auditing drug and medical product applications, as well as committees for adjudication, awarding, and procurement, the decision established official communication channels with companies and their representatives. Communication must be conducted through the committee chair or an official body designated by the Ministry. Companies may attend evaluation committee meetings only upon formal invitation to provide specific technical clarifications, without participating in deliberations or voting.
The decision mandated the disclosure of any conflicts of interest related to the company or the product under evaluation, using forms approved by the Ministry. It also obliged companies, upon request by the Ministry, to submit organized technical files containing clinical evidence, therapeutic comparisons, safety data, regulatory status, financial impact, and other requirements specified by evaluation and audit committees.
The decision established controls for approving promotional materials before distribution, display, or transmission within Ministry facilities, regulating their content to ensure information accuracy, proper presentation of scientific evidence and results, and the prohibition of undocumented comparisons or unsupported claims.
In organizing professional interactions, the decision prohibited the offering or presentation of personal gifts, cash amounts, vouchers, bonuses, commissions, recreational hospitality, travel, non-scientific activities, or any personal benefit that could influence or be perceived to influence professional, technical, or purchasing decisions. Institutional support for scientific or training activities is permitted in accordance with Ministry regulations, ensuring transparency.
The decision obliged companies and their representatives to comply with its provisions within a period not exceeding three months from its issuance date. It entered into force upon issuance and was published in the Official Gazette.
The decision specified the locations excluded from visits, including clinics, emergency departments, wards, patient rooms, operating theaters, treatment and diagnostic areas, pharmacies and their storage facilities. It also emphasized that there should be no direct contact with patients or their families, no access to their medical records or health data, and no entry into storage or waste disposal areas, or procurement and tendering zones, unless with official approval and for a specific non-promotional purpose.
Regarding pharmaceutical samples, the decision regulated the mechanisms for their submission, approval, and distribution through official channels, and prohibited company representatives from directly distributing samples to healthcare providers or patients within the Ministry’s facilities, while imposing requirements related to registration, quality, clinical need, storage, traceability, and dispensing.
The decision outlined procedures for handling violations according to their nature and severity, ranging from issuing warnings and requesting the modification or withdrawal of promotional materials, to suspending or banning a company representative’s access to Ministry facilities, halting promotional activities for a specified period, and referring cases to the relevant regulatory or legal authorities when necessary.
