Approval Process for Medical Marketing REF#6081

The marketing of healthcare products in Cambodia is tightly regulated by the Ministry of Health to ensure that the claims, content and appearance of such activities are legitimate and any potential risks to patient safety are minimised. These regulations require healthcare companies to seek prior approval from the Ministry for any materials and events that they wish to utilise to advertise their products before they can be released to the public, healthcare professionals and industry stakeholders.

While this is standard practice in many countries, our members perceive there to be an increased level of uncertainty surrounding the approval process in Cambodia, due to recent changes in practices by the Ministry, which have not yet been formally officialised, despite in some cases already being enforced. Our members report that for branded promotional materials that are often given to medical professionals such as laboratory logbooks, which previously did not undergo such scrutiny, companies are now required to seek approval. Likewise, for other materials such as gimmicks, it is extremely difficult for manufacturers to procure an actual single sample because of manufacturing constraints, and this may, in practice, prevent companies from seeking approval for their marketing materials.

The uncertainty caused by a divergence from past processes also extends to the approval process required for companies to organise or attend medical marketing events and meetings with healthcare professionals. Previously, company representatives were permitted to attend joint meetings with medical associations, if the association itself had received approval, though in some cases the Ministry now requires both the association and individual companies attending to obtain separate approval. Similarly, the approval granted for medical events was previously valid for a period of one month, giving companies the flexibility to reasonably change plans, however the Ministry now requires the event to occur on the exact date for which approval has been requested. This has led to a situation where companies are unable to invite healthcare professionals that are useful in providing a valuable medical message, as by the time the approval is obtained, it is too late to book these sought-after professionals for a specific date.

The difficulties surrounding this approval process are compounded for events held outside Phnom Penh, particularly in Battambang, Siem Reap, and Kampong Cham, as companies must seek approval from the Ministry as well as from the provincial Health Departments, creating an unnecessary, additional administrative burden. We would like to thank the Ministry for their efforts already taken to prevent the duplication of approvals by local authorities, however, our members report that this issue persists.

Healthcare companies support the need for a suitable regulatory framework for the industry to ensure that companies do not act inappropriately or make false claims in their marketing materials that could potentially harm the public. Accordingly, the healthcare sector requires such regulations to be unambiguous, consistent, and accompanied by formal guidelines that enable companies to establish what marketing is acceptable and what is unacceptable before submission to the Ministry of Health.

Like all other private industries, healthcare companies utilise effective marketing strategies to differentiate their product offering and maintain their position in the market against their competitors. This fosters a competitive healthcare sector that encourages greater investment from multinational companies, bringing improved healthcare quality standards. Marketing events and materials are also used by pharmaceutical companies to disseminate important evidence-based medical information to healthcare professionals about their products, as well as non-promotional medical information such as scientific updates on international guidelines and new clinical evidence. The objective of this is to support healthcare professionals to choose the best treatment for their patients, according to the availability of products on the market.

However, a lack of clear guidelines on what marketing is permitted and when companies are required to seek approval creates an ambiguous regulatory environment, making it more difficult for companies to do business in Cambodia and negatively impacts prospective investor sentiment. Cumbersome regulatory processes that reduce competitiveness ultimately affect patients’ access to advanced, life-saving treatments, as healthcare companies are unlikely to bring such treatments to a new market if they cannot be assured of a return on their investment.