Medical decisions in the best interest of patients
The Food and Drug Administration (FDA) recently issued an advisory against unethical business practices related to the promotion of prescription products and medical devices.
Signed by FDA Director General Samuel Zacate, Advisory 2022–2045 reads “in the interest of service, and to ensure that medical decisions are made in the best interest of patients, the Food and Drug Administration warns all Prescription Pharmaceutical Products and Medical Devices companies, and Healthcare Professionals, not to engage in unethical business practices.”
Based on Administrative Order (AO) No. 2015-0053 titled “Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices,” the Advisory is relevant to the government and the healthcare community’s campaign for integrity.
It has long been established that the ethical promotion of prescription medicines is vital to the pharmaceutical industry’s mission of helping patients through research and development of new and innovative medicines.
Ethical promotion helps to ensure that healthcare professionals (HCPs) have access to the right information they need and that right patients have access to the right medicines at the right time.
For example, the interactions between manufacturers of coronavirus disease 2019 (COVID-19) medicines and vaccines with medical frontliners have been key in saving people’s lives.
In guiding these interactions, the Pharmaceutical and Healthcare Association of the Philippines (PHAP) developed its own Code of Practice aligned with global and regional codes as well as national laws.
The Code seeks to preserve the independence of the decisions taken by healthcare professionals in prescribing medicines to patients. It also emphasizes that industry relationships with HCPs must support, and be consistent with the professional responsibilities they have with their patients.
In its 2020 edition, the PHAP Code said that pharmaceutical companies must maintain high ethical standards in the conduct of promotional activities to HCPs, patient groups, and patient organizations and comply with applicable legal, regulatory, professional requirements and international guidelines on face-to-face and virtual interactions.
Compliance to the Code of Practice is a prerequisite to membership, and is governed by an independent ethics committee which is composed of the country’s health and academic luminaries.
Citing AO 2015-0053, the FDA said that the industry-HCP relationships shall be based on ethics and transparency to assure the independence of HCP’s medical decisions and focus on protecting patients’ welfare.
Also, relationships between company personnel and HCPs shall encourage the development of a healthcare practice committed to patients’ well-being based on truthful, accurate and updated scientific evidence.
The AO directed that PPPMD companies have the ethical obligation to ensure that their interactions with HCPs are in accordance with all applicable laws and regulations.
Moreover, it restated provisions on promotional information and activities. It said that no PPPMD company shall employ or contract any HCP or health worker to promote, advertise, or endorse any pharmaceutical products or medical device in mass media, print, audiovisual display, or social media.
The Advisory likewise included provisions on entertainment and recreation. It said that to ensure appropriate focus on education and informational exchange, and to avoid the appearance of impropriety, prescription pharmaceutical products and medical devices (PPPMD) companies shall not provide any form of entertainment that would incur expenses for recreational items such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any HCP.
It added that entertainment or recreational benefits shall not be offered regardless of 1) the value of the items; 2) whether the company engages the HCP as a speaker or consultant; or 3) whether the entertainment or recreation is secondary to an educational purpose.
Relatedly, no stand-alone entertainment or other leisure or social activities shall be provided or paid for by companies during scientific meetings. PPPMD companies are also prohibited from paying any travel sponsorship, meals, or other expenses of accompanying guests or family members of HCPs.
In connection with educational items and gifts, any item which does not have any direct patient benefit or is not related to the work of the HCP shall not be permitted.
Finally, gifts or personal services and benefits unrelated to the work of the HCP shall not be provided by any PPPMD company representative to an HCP or members of the families. When these are followed, all medical decisions will be in the best interest of patients.