Phytotherapeutic products are derived from natural sources like plants and herbs. They have potential health benefits to prevent or treat disease but can also be key to maintain health. Why is is then that they are most often registered as food supplements and not as medicines? Let’s have a look at the many & complex reasons.
Stringent Clinical Trials
The registration of a pharmaceutical medicine demands rigorous clinical trials that provide evidence of safety, efficacy, and consistent results. One of the most significant hurdles preventing phytotherapeutic products from registering as medicines is their intricate composition. Unlike synthetic drugs, which typically involve one or a few specific molecules, phytotherapeutic products contain a plethora of ingredients. On top of that, since they are derived from natural sources, their exact composition can vary due to factors such as harvest times, locations, and growth conditions. This diversity makes it challenging to conduct clinical trials which are designed to evaluate and test medicines with a simple and consistent composition. It is believed by some that it would make sense to demand other clinical trial requirements suited to the nature of phytotherapeutic products which would still provide proof of efficacy and safety.
Costs, Timeframes and Patent Challenges
The process of registering a product as a medicine involves significant financial investments, including the costs of clinical trials and regulatory filings. The timeframes are lengthy and can be uncertain due to changing regulations. In contrast, marketing a product as a food supplement is often quicker, more cost-effective, and carries fewer regulatory burdens.
Another hurdle that stops manufacturers to conduct the elaborate and expensive clinical trial process, is the difficulty in patenting natural sources. Unlike synthetic drugs, which can be patented based on specific molecules, phytotherapeutic products often lack this level of patent protection. This opens the door for competitors to replicate similar products as food supplements without the same level of scrutiny.
Limited Health Claims
In the European Union (EU), health claims for food supplements are regulated by strict guidelines. This limitation hampers manufacturers’ ability to communicate the potential benefits of their products to consumers.
So, on the one hand, it is an extremely difficult (to impossible) and expensive process to attempt the registration of a herbal medicine as a pharmaceutical medicine. On the other hand, when registered as a food supplement, there is an enormous limitation on the potential health claims that can be communicated. You can see, this puts these valuable products in a conundrum position.
Traditional use
It is worth mentioning here that the registration process of a phytotherapeutic product can be facilitated when there is proof that it has been used traditionally for specific health-related purposes without adverse effects. Such historical evidence can help substantiate the product’s claims and, in some cases, somewhat lessen the need for extensive clinical trials. It can be especially relevant in regions where traditional medicine plays a prominent role and is a valuable asset in registering phytotherapeutic products while ensuring their safe and effective use in contemporary healthcare.