On 27 July 2015, the Minister for Social Affairs and Public Health, Maggie De Block (“the Minister”), and the pharmaceutical sector umbrella organisations pharma.be and FeBelGen entered into a “Pact for the Future” (Toekomstpact/Pacte d’avenir – the “Pact”). In the Pact, they agree on a significant number of measures in the pharmaceutical field for the period 2015-2018.
The Pact groups these measures under four main headings: (i) accessibility; (ii) growth and innovation; (iii) ethics; and (iv) budgetary durability and predictability.
Accessibility
The Pact’s principal goal is to make innovative therapies easier and earlier accessible for patients. This goal should be achieved through the following measures:
- Innovative medicines will become reimbursable as from the date of publication of the Minister’s positive decision on the website of the National Institute for Sickness and Invalidity Insurance (Rijksinstituut voor Ziekte- en Invaliditeitsverzekering/Institut national d'assurance maladie-invalidité). According to the Pact, this will make new and innovative medication available at least two months earlier than is now the case.
- The assessment procedures will be accelerated by (i) shortening the applicable time frames where appropriate; and (ii) avoiding duplication of any work that has already been carried out at a different level, whether national or international.
- The prices to be paid by patients will decrease.
- The Minister will aim for closer cooperation at the European level in order to foster the development of, and patient access to, medicines for unmet medical needs and orphan medicines.
Growth and innovation
The Pact identifies three policy priorities to stimulate growth and innovation:
- The first priority is to create a stable, predictable and trustworthy environment for R&D in the pharmaceutical field. The Pact stresses the importance of financial, fiscal and legal certainty. It will be examined whether there is scope for introducing a biotechnology tax shelter for early phase developments. Moreover, a central contact point will be established to provide regulatory support to biotechnology spin-offs and start-ups. In addition, it will be made easier to use human body material for R&D purposes and a clear regulatory framework will be established to stimulate the development and production of advanced therapy medicinal products.
- The second priority is to monitor the competitive position of the Belgian pharmaceutical industry on a permanent basis.
- The third priority is to support innovation, in particular by fostering clinical trials (e.g., by facilitating patient recruitment) and by assessing to what extent access can be given to (anonymised) data contained in data bases such as farmanet and the “permanent sample” (Permanente Steekproef/Échantillon Permanent) of the Intermutualistic Agency (InterMutualistisch Agentschap/Agence InterMutualiste).
Ethics
The Pact stresses the importance of ethical requirements, including the following:
- the requirement for pharmaceutical companies to act in the interest of the patient;
- the requirement for pharmaceutical companies to ensure a maximum degree of transparency in their relations with healthcare providers and healthcare institutions (including the requirement to publish any “transfers of value” on the platform betransparent.be);
- the requirement to publish all clinical trial results, even if they are negative or unfavourable; and
- the requirement to provide proper and correct information about medicines (in this regard, the Pact questions whether the rules on advertising for non-prescription medicines achieve their goal – are patients able to grasp the main messages considering the long list of mandatory statements to be included in advertisements for such medicines?).
Budgetary durability and predictability
Finally, the Pact sets out the budgetary framework for the years 2015-2018. While explaining that the pharmaceutical industry will face additional savings in the amount of, at least, EUR 126 million between 2016 and 2018, the Pact points out that the budgetary framework increases predictability and thus makes it easier for pharmaceutical companies to plan their R&D projects. The budgetary framework thus provides for the following:
- a budget increase limited to 0.5% (on average) over the years 2016-2018;
- a price decrease of off-patent medicines, of which the revenues (EUR 350 million/year between 2015 and 2018) will be invested in the development of innovative medicines;
- the introduction of a “patent cliff”, i.e., a single, sharp decrease in the price of medicines that go off-patent (instead of the current successive price decreases pursuant to the reference reimbursement system/system for “old medicines”);
- the creation of incentives for biosimilar products; and
- a decrease in the turnover levy to be paid by pharmaceutical companies from 7.73% to 6.73% (i.e., a decrease by 13%).
The Pact is available at
http://www.deblock.belgium.be/sites/default/files/articles/20150727%20toekomstpact.pdf (Dutch version) and
http://www.deblock.belgium.be/sites/default/files/articles/20150727%20Pacte%20d%27avenir.pdf (French version).
