The technology industry used to be a rather fragmented field, where each company had its own expertise. Now, we are moving toward more integrated models, where developments in pharma, IT, medical devices and food are crossing technological borders. However, the legal framework has not yet adapted to this changing landscape. Technology is evolving at the speed of light, and the law lags behind.
Regulatory status of a product
A new product can fit into many "boxes", i.e., it can be a medicinal product, medical device, in vitro diagnostic, food supplement, cosmetic, biocide or even a consumer IT product. The correct classification of a product is of major importance, as the legal consequences from a compliance point of view can be huge .
For instance, the market access conditions are entirely different for products from different categories. Medicinal products can only be placed on the market after being validated in a set of clinical trials, whereas this is not the case for food supplements. The commercialization of medical devices involves CE marking, materiovigilance processes and a notification of the product to the national authorities. There is a branded reimbursement system for medicinal products, but with medical devices, this only applies to implants and invasive devices. The rules for advertising are also remarkably different for different kinds of products. You are prohibited from advertising medicinal products to the general public, but you do not have that prohibition for medical devices, except again for implantable devices. Also, in terms of surveillance authorities, registration and notification, promotion to healthcare professionals, distribution chain, post-marketing surveillance and safety, you have a very different regulatory framework.
How do you determine to which category your product belongs ? It may look simple on paper, as shown below for a medicinal product and a medical device.
The legal definition of a medicinal product is based on two important criteria: presentation and function. A medicinal product is presented as having properties that allow it to treat or prevent a disease. It can also be a substance that aims to correct or modify body functions by exerting a pharmacological/immunological/metabolic action.
The medical device field is huge: It contains medical equipment as well as lenses, pacemaker software and certain health apps. The most important criterion to differentiate a medical device from a medicinal product is that the device does not achieve its principal intended action by immunological, pharmacological or metabolic means.
But because the technological borders are fading, there are now more and more borderline products where it is unclear into which "box" they should be classified. These grey area products include nutraceuticals (between medicinal product and food), cosmeceuticals (between medicinal product and cosmetics), combinations of a medicinal product and a medical device, or products that are at the borderline between software and medical device. In certain cases, the surveillance authorities can decide to "requalify" a product. For instance, national authorities can decide that a product that was commercialized as a food supplement is actually a medicinal product (for which clinical studies should have been performed) or even a medical device. The authorities can then order a withdrawal from the market or other corrective actions. Such cases can be litigated before the courts.
Healthcare and software are becoming more and more integrated, and this has legal implications. “Health apps can be lifestyle gadgets or actual medical devices,” explains Christel Brion, lawyer at NautaDutilh. “There is still a lot of legal uncertainty about how some of these apps should be classified, but there are (non-binding) guidance documents available. For stand-alone software, if (i) the app performs an action on data that differs from mere storage, archiving, communication or simple search, (ii) there is an action for the benefit of individual patients and (iii) the intended purpose is for diagnosis or treatment, it would fall under the regulatory statute of a medical device. An app that tells you to adjust your insulin dosage based on a reading from a glucometer is intended for the benefits of an individual patient and used for the purpose of diagnosis, so it is a medical device.
Consider the regulatory status of your product from the start of the development and enter into a dialogue with the authorities.
On the contrary, an app that tracks your exercise routine without being used for a form of diagnosis or treatment is in principle a lifestyle device and thus is not submitted to the medical device regulatory framework. People in the (startup) IT world are sometimes not aware that if they develop healthcare-related software, it could be considered as a medical device, and then they fall within a regulatory framework.” The criterion of the principle intended action is the key element when it comes to making the distinction and drawing the line. “My advice? Consider the regulatory status of your product from the start of the development and enter into a dialogue with the authorities," Brion concludes .
This article is a report of the keynote presentation by Christel Brion, Senior Associate, NautaDutilh, on the Janssen - FlandersBio Partnerday, March 3, 2016