NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
8.4 Cost-Benefit Analyses As mentioned in 8.3 Reimbursement From Public Funds , ZiN is tasked with advising the MoH on reim- bursement of, inter alia, medicinal products. Indeed, ZiN is responsible for performing HTA, including cost- benefit analyses. Such cost-benefit analyses therefore play an important role for both the price and reim- bursement status of a medicinal product. For the pur- poses of (amongst others) these cost-benefit analy- ses, ZiN is assisted by the Scientific Advisory Board ( Wetenschappelijk Adviesraad ). The price of medical devices is generally decided as a result of negotiations between healthcare insurers and providers of medical devices. Such price negotiations generally (also) result in parties agreeing on an “all-in price”, where the price not only includes the specific medical device but also includes adjacent services Article 61 Medicines Act provides a prohibitory provi- sion for, inter alia, the dispensing of prescription-only and pharmacy-only medicinal products. Furthermore, pursuant to Article 36 (14) of the Individual Healthcare Professions Act (Wet BIG), only a limited number of healthcare professionals (eg, medical practitioners, dentists) can prescribe medicinal products. In general, the following is of note in the context of prescribing and dispensing medicinal products: • The Wet BIG includes disciplinary rules that must be complied with by healthcare professionals, including pharmacists. In that respect, healthcare professionals must comply with the principle of good care (Article 40 Wet BIG). • In order to satisfy their “good care” obligation, pharmacists must comply with specific profession- al guidelines, which typically set out what consti- tutes “good care”. Adhering to these professional guidelines is not voluntary, as competent authori- (eg, monitoring, customer service, etc). 8.5 Regulation of Prescriptions and Dispensing by Pharmacies ties (as well as, for instance, healthcare insur- ers) can use these guidelines to assess whether pharmacists act in compliance with the principle of good care. • Dispensing medicinal products (as well as advis- ing patients on their use and monitoring such use)
therapy (generally relevant in the context of pharmacy preparations). This is the case if the medicinal product (i) has a suitable pharmaceutical form for the specific patient, (ii) is proven to be working and effective, and (iii) is the most cost-effective option for, respectively, the healthcare insurer or the patient. For medicinal products utilised for inpatient purposes, a different mechanism applies. Article 2.4 Bzv stipu- lates that insured patients have a right to “medical care” ( geneeskundige zorg ) that is commonly provided by medical specialists ( medische specialisten ). If such medical care includes the use of medicinal products, these medicinal products will generally be reimbursed as part of the received medical care. In short, whether care is (fully) reimbursed depends on a variety of circumstances, such as whether: • the care falls within the scope of the basic pack- age; • the received care is contracted by the healthcare insurer; • the medicinal product is designated by the MoH; • the healthcare insurer designated the specific medicinal product; and • a medical practitioner issues a statement indicating that: (a) treatment with the preferential product is medi- cally unjustifiable; and (b) the insured requires a specific (other) medicinal product; and • some of the (other) exceptions apply. Medical Devices Medical devices are treated somewhat differently to medicinal products as it is generally up to the health- care insurers to determine whether a specific medical device is eligible for reimbursement from the basic package. In that respect, healthcare insurers will gen- erally assess whether (i) new devices meet the legal requirement of “established medical science and medical practice” ( stand van de wetenschap en prak- tijk , SW&P) (Article 2.1 (2) Bzv) and (ii) the insured is reasonably reliant (or better: requires) on a specific medical device (Article 2.1 (3) Bzv). However, in terms of the latter criterion, the professional autonomy of the medical practitioner (the referrer) is generally leading.
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