Diederik Schrijvershof, Jeanne Plettenburg and Wouter Jans have successfully created a level playing field for eyecare medicines and devices.
An international producer and end users of eye drops and eye creams sold as medical devices were contending with an uneven playing field. Healthcare insurers refused to compensate their insured if they purchased eye drops or eye creams as medical devices, even though healthcare insurers do reimburse those products when they are sold as medicines. Several large healthcare insurers believed that eye drops and eye creams could in no event be considered medical devices. According to them, those products are therefore not eligible for reimbursement as medical devices under basic health insurance. That argument has been dismissed and is no longer tenable.
Maverick Advocaten successfully obtained rulings in separate proceedings in which the court found that several types of eye drops and eye creams are medical devices and are eligible for reimbursement under basic health insurance. The Disputes Committee of Stichting Klachten en Geschillen Zorgverzekeringen (“SKGZ”), for instance, has issued several binding rulings (see here, here, here and here) in which it found that medical devices related to visual disorders must be reimbursed under basic health insurance and that the eye drops and eye creams in question fell into that category. Those rulings were issued after the Dutch National Healthcare Institute (“ZIN”) advised SKGZ that eye drops containing hyaluronic acid come under the function-oriented description in Article 2.13(1)(a) of the Healthcare Insurance Regulations. The ZIN found after an investigation that those eye drops are “state of the art and state of practice” in accordance with Article 2.1(2) of the Healthcare Insurance Decree. According to the ZIN, insured persons are entitled to reimbursement of those eye drops if they are reasonably dependent on them in terms of content and scope. At Maverick Advocaten’s request, the ZIN subsequently also changed the text on its website regarding the reimbursement of moisturising eye drops as a medical device.
It is relevant to the reimbursement of medical devices related to visual disorders, such as eye drops and eye creams, that, according to SKGZ, healthcare insurers may not simply impose a prior-approval or fixed-term approval requirement. According to SKGZ, healthcare insurers were doing so wrongly and had to change their procedures.
Now that eye drops and eye creams can be classified as medical devices as well as medicines, without that affecting the right to reimbursement under basic health insurance, a patient’s wish carries more weight in the selection of a certain medicine and a level playing field has been created for medicines and medical devices for visual disorders.
More information on competition law and the duty of care of healthcare insurers in the medicines and medical devices sector can be found in this blog.