Kuwait tightens screws on pharma ‘promotion’; Reps lose ‘free’ rein

It states that companies should not practice as medical representatives without obtaining a permit from the Pharmaceutical Inspection and Licensing Department. This permit must be personal, non-transferable, and valid for a period not exceeding one year, renewable annually. The permit application must be submitted online, along with the authorization of the company, credentials of the authorized representative, commercial license, academic qualifications, photograph and civil identification card. It requires companies to notify the ministry of any changes in the representative’s information or termination of the relationship with the company. It prohibits company representatives from entering hospitals and healthcare facilities without an appointment and approval from the relevant authority. They are required to present their identification card and permit upon entry. Company representatives are prohibited from entering clinics, emergency rooms, wards, patient rooms, operating theaters, healthcare delivery areas, and storage and dispensing areas. They are not allowed to communicate with patients or their families, access their files and data or enter procurement and tender areas without obtaining official approval and must do so for non-promotional purposes.

The decision emphasized the prohibition of direct promotional communication between companies and members of committees in charge of drug evaluation, tender awarding and procurement. Communication must be exclusively through the committee rapporteur or the official entity designated by the ministry. Company representatives are not allowed to attend committee meetings except through official invitation to provide technical clarifications, and without participating in deliberations or voting. Committee members are obligated to disclose conflicts of interest.

The ministry is authorized to request a comprehensive technical file from companies, including clinical evidence, therapeutic comparisons, safety data, financial impact assessments, and proposed restrictions, as required by the evaluation and audit committees. The decision prohibits the provision of gifts, cash payments, coupons, rewards, commissions, recreational trips and hospitality or personal benefits to healthcare providers or committee members. It is prohibited to link sponsorship, travel, accommodation or support to the prescription, dispensing, purchase or inclusion of a medical product.

The decision allows institutional support for scientific and training activities, subject to the regulations of the ministry, provided that transparency is maintained and that it does not influence therapeutic, regulatory or procurement decisions. It stipulates that lectures, seminars and scientific meetings sponsored by companies must have balanced content, with the sponsoring company’s name and role clearly displayed. It prohibits company representatives from distributing pharmaceutical samples or medical products to healthcare providers or patients free of charge within the ministry facilities. Samples must be submitted through official channels.

No pharmaceutical samples are accepted without verification of registration, quality, and source, and compliance with storage, traceability and dispensing requirements through the official channels specified by the ministry. It stipulates that the remaining shelf life of the sample must be at least six months and clearly marked ‘Free Sample’ in both Arabic and English. It prohibits the use of samples to influence medication prescribing patterns or to violate approved drug list and procurement regulations. It authorizes the ministry, upon confirmation of a violation, to issue a verbal or written warning, or to withdraw or amend the promotional material. The company is obligated to issue an official correction of misleading information, and the representative’s permit will be suspended or he will be barred from entering ministry facilities.

The promotional activities of the company will be suspended and the violation will be referred to regulatory or legal authorities. The decision categorizes violations as minor, moderate and serious. Serious violations are promoting products outside the approved use, providing misleading information, pressuring committee members, violating conflict of interest rules, offering benefits or bribes, falsifying data, or influencing procurement, listing and tender decisions.

It specifies official forms for implementing its provisions, including registration of company representatives, commitment pledges, review of promotional materials, disclosure of conflicts of interest, reporting of violations, and files for drug listing or restriction applications. It grants all companies and their representatives a grace period of three months from its issuance date to comply with its provisions. It takes effect from the date of its issuance and will be published in the official gazette, ‘Kuwait Al-Youm’, and any conflicting decision or provision shall be repealed.