The cost control of pharmaceutical products remains an important topic in the Netherlands. Recently, the Dutch Minister of Medical care and Sport announced his intended measures to control the development of the expenditure in a letter to Parliament.
The minister has set out several envisaged measures and initiatives at an international, national and decentralised level. The purpose behind the measures is achieving acceptable prices for medicinal products, whilst keeping the products accessible and available for patients.
Most of the measures and initiatives are still quite unspecific and legislative proposals still have to be developed. The most relevant and concrete intended measures are in short as follows:
1. International level
- Together with other EU Member States, the Netherlands intends to assess whether regulatory data protection, market exclusivity and supplementary protection certificates (SPCs) lead to desired results. The minister believes these may lead to high prices and price increases.
- The Netherlands continues to cooperate with other EU Member States on health technology assessment (HTA) and horizon scanning in the framework of the BeNeLuxA initiative.
- The Dutch minister aims to increase price transparency between countries.
2. National level
- The system of external reference pricing will be amended by replacing Germany by Norway as a reference country. It is announced that a legislative proposal to amend the Medicines Prices Act (Wet geneesmiddelenprijzen) will be submitted later this year. The replacement should enter into force as of 1 January 2020. The choice for Norway was made because that would result in more cost savings due to lower price level of originator medicinal products in that country, while Norway has a similar level of prosperity and healthcare system.
- Continuation and expansion of financial arrangements for expensive medicines and regulation of the "lock" (sluis). Hospital medicinal products that are placed in the so called "lock" are excluded from reimbursement. As of 1 July 2018, the criteria to place hospital medicines in the so called "lock" are laid down in the Healthcare Insurance Decree. A medicinal product will be considered to be placed in the "lock" if:
- The expected costs at macro level amount to EUR 40 million or more per year, for the treatment of one new indication alone, or several new indications together. All indications are placed in the lock; or
- The expected costs at macro level amount to EUR 10 million or more per year and the costs for treatment of a new indication alone amounts to EUR 50,000 or more per year. This indication is placed in the lock.
- The Minister has looked into the possibilities to make use of compulsory patent licenses in case of excessive prices for medicinal products. A committee will be set up to further investigate the possibilities and consequences for compulsory licenses, from an economic and legal perspective. The Minister noted that even despite a compulsory license, there would be barriers to place a medicinal product on the market, due to regulatory data and/or market exclusivity. As these regulatory exclusivities are regulated at EU level, the minister announced that he will discuss with the European Commission whether there will be possibilities to lift data or market exclusivity in case of compulsory licenses.
- Modernisation of the current reimbursement for out-patient medicinal products was announced. No specific measures have however been presented yet.
- The Minister pleads for price transparency. Without announcing specific measures, the Minister has expressed the view that there should be a clear and acceptable relation between the price of a medicinal product and its development costs. The Minister has opened discussions about this with originator pharmaceutical industry.
3. Decentralised level
- Maintaining the possibility for health insurers to apply a "preference policy" by reimbursing only one medicinal product with a certain active substance and excluding other products with the same active substance;
- Increasing availability and knowledge about biosimilars. In this regard the program "Implementation of tailor made biosimilars in hospitals" received a grant of EUR 750.000; and
- Clarifying the possibilities for pharmacy compounding.
Click here to read to full version of the Dutch letter to Parliament (dated 15 June 2018).