Last week, the creation of the new Advisory Group on the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects. Its task is to issue advice on the legislation to be applied to individual products / product groups / substances belonging to a group of so-called borderline products. The reason that this Advisory Group was created is that the regulations in the field of market authorization and research with such products are complex and that it is not always clear which law is applicable. In such case it is also not clear which enforcement authority is competent to act in case of violations of the law. This is deemed undesirable by both the marketplace and the government authorities and the Advisory Group aims to change this.
Demarcation issues not new
Demarcation issues at the interface of the laws applicable to food products and medicinal products are not new. Already in a 2008 Letter to Parliament, the Dutch Health Minister reported that there was insufficient clarity about the demarcation between medicinal products and herbal remedies. The Minister reported the issue that a herbal remedy could also be a medicinal product within the meaning of the Dutch Act of Medicinal Products (in which the Medicinal Products Directive 2001/83 has been implemented). This is a consequence of the fact that the Act does not make a distinction between the origin of any active substance, which can be of human, animal, vegetable or chemical origin. When a herbal preparation qualifies as a medicinal product by function or by presentation, the Act on Medicinal Products is equally applicable.
Measures announced in the Letter of Parliament
At the time, the Health Minister did not consider it necessary to adjust the regulations to prevent demarcation issues between food products and medicinal products. He considered the criteria of "medicinal product by presentation" and "medicinal product by function" to be sufficiently clear in the first place. Secondly, he expected a beneficial effect from the list of permitted health claims that still had to be published back in 2008. He anticipated that products bearing such claims would not qualify as a medicinal product by presentation. He did, however, consider it desirable to improve cooperation between the Heath Care Inspectorate and the Food Safety Authority. This was implemented by adjusting the Decree on Supervision of Public Health, as a result of which the Food Safety Authority gained authority to enforce violations of the Act on Medicinal Products. Furthermore, it was stipulated that the structured consultation between the Heath Care Inspectorate, the Food Safety Authority and the Medicines Evaluation Board should be intensified, particularly regarding the discussion of the status of borderline products. One can say that this consultation in fact operated as an Advisory Group avant la lettre. Finally, it was determined that the already existing cooperation agreement between the Heath Care Inspectorate and Food Safety Authority had to be updated.
Demarcation issues more topical than ever
We now know that the clarification brought by the list of authorized health claims published in 2012 should not be overestimated. Nowadays many functional foods and nutraceuticals are marketed that claim medical properties. It quite often happens that it is not clear what is the applicable legislation to these products, because the boundary between health claims, disease risk reduction claims and medical claims is not immediately clear in all cases. Even when no specific claim is used, it can be debatable whether a product is a medicinal product by function or any other health product. It also happens that more or less the same products are marketed simultaneously as a medicinal product and as a foodstuff. Consider, for example, products containing glucosamine or St. John's Wort. This means that food products containing the same active substance as medicinal products have not passed the prior testing for quality, safety and efficacy, which can be confusing for the consumer.
Consequences of product qualification
There are many examples of food products that were considered medicinal products by presentation. Consider, for example, the melatonin products which, after a remarkable turn in the Health Care Inspectorate policy, initially not but later on were considered to be medicinal products. More recently, a medical claim that Milk Thistle could prevent liver fattening was considered misleading. Furthermore, it was determined that a dietary supplement that would promote the natural immune system, would have a beneficial effect on heart and blood vessels and would help to treat fatigue qualified as a medicinal product. When such disputes are dealt with before the Civil Court, quite often fines are imposed for violations of the Act on Medicinal Products, prohibiting, among other things, the marketing and advertising of medicinal product without a marketing authorization. When these disputes are submitted to the Advertising Code Committee, usually a recommendation is made to no longer use such misleading information based on these regulations and the Code on Public Advertising of Medicinal Products. In order to prevent such enforcement activities, manufacturers of health products have every interest in knowing in advance how their product qualifies. They then know which regime applies to their product and can take this into account in their communication (advertising campaigns).
Working method Advisory Group
How does the Advisory Group work and which aspects are covered by its advice? Upon request of one of the competent authorities, the Advisory Group advises on the applicable legislation to individual products, product groups or substances. This advice gives a motivated indication of the law that applies to the opinion of the Advisory Group at the time of assessment and given the available information. "Available information" refers not only to factual information but also to applicable case law, both in the Netherlands and abroad. The advice will be presented to the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects, who will subsequently respond to this within four weeks if so desired. If the responses give cause to do so, the Advisory Group reconsiders the advice and if necessary adjusts it. The advice is then recorded in its database, which is managed by its secretariat. There is also a possibility that the Advisory Council will not reach agreement on the applicable legislation. In such a case no advice is issued; this is also recorded in the database. The Advisory Group can also change its advice in the event of changes in the legal framework. The competent enforcement authorities must report those change to the Advisory Group, which registers an amendment to a previous advice in its database, if and when applicable. For clarity, the advice assesses neither the efficacy, safety or efficacy of medical products nor the content of any research protocols.
Added value Advisory Group
Can it be expected that the Advisory Group will make a substantial contribution to demarcation issues? In itself, the intensified co-operation between all the authorities involved, at market entry rather than upon enforcement during marketing, is to be welcomed. For example, in practice, food business operators also benefit from the working agreements between the Council on Advertising Health Products and the Food Safety Authority, on the basis of which health products bearing a "stamp" of said Council are in principle not exposed to enforcement actions by the Food Safety Authority. However, it appears from the currently published agreement between the parties involved in the Advice Group that only the enforcement authorities and not the individual manufacturers can request advice from the Advisory Group. This appears to be a missed opportunity, as is the fact that the efficacy of medicinal products remains explicitly outside the Advisory Council's assessment. To qualify the essential character of a health product, efficacy is one of the essential factors. Furthermore, it is noteworthy that the Advisory Group does not seem to address the issue of medical devices, while this qualification is closely linked to that of medicinal or food products. For example, cranberry pills against bladder infection qualify as medical devices and osmotic laxatives can be either medicinal products or medical devices.
Advice on market access for health products
For the time being, manufacturers of health products will continue to rely on private advice from qualified advisors on market access for health products. Nevertheless, the body of opinions to be produced by the Advice Group can be a valuable source of information, provided that its database will be publicly searchable. The rules of procedure of the Advice Group, which are yet to be made available, will have to provide clarity in this respect.
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