Belgium - Medicine Shortages
- 20/12/2019
- Articles
On 19 December 2019, the federal House of Representatives adopted bill 55K229 modifying various laws to tackle medicine shortages (Wetsvoorstel tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Proposition de loi modifiant diverses legislations, en ce qui concerne les pénuries de medicaments) (the Bill).
As is the case in many countries across Europe, medicine shortages are thought to be a pressing health problem that requires urgent action. The Bill seeks to address at least part of that problem and is expected to be complemented by a range of Royal Decrees that should be in place by 31 January 2020. The Bill includes the following key features:
- It tightens the notification requirement of temporary supply cessations.
- It equates a partial supply with a temporary cessation of supplies that gives rise to notification.
- Medicines that are affected by supply cessations may be made subject to a temporary export limitation or prohibition. A Royal Decree will determine detailed rules. The lawmakers are confident that a focused export restrictions procedure which results in narrow export limitations will pass muster under European law, unlike the blanket export ban which the Constitutional Court first suspended and later annulled earlier this year (see, Van Bael & Bellis Life Sciences Newsflash of 19 July 2019 and 17 October 2019).
- Wholesalers with a public service obligation and pharmacists now benefit from a supply obligation in their favour of three working days. It is thought that this rule will counter the possible shortages resulting from the application of supply quota systems by pharmaceutical firms.
- Any costs resulting from a temporary supply obligation will be borne by the marketing authorisation holder. The Bill seeks to avoid that such costs burden the patient or the social security budget.
- If a medicine is not available, the pharmacist will have the right to replace that product with an alternative that has the same active substance, the same dosage, the same route of administration and the same frequency of administration. It will be possible for the prescribing physician to object against this form of substitution in a given case.
The Bill will not be notified to the European Commission pursuant to Directive 2015/1535 which requires Member States to advise the Commission and other Member States of the technical regulations which they intend to introduce for products and for Information Society services before their adoption. By contrast, according to the Parliamentary works that accompany the Bill, the Royal Decree that will govern the export restrictions will probably be notified under that Directive. However, to the extent this is true, the deadline of 31 January 2020 for having the entire regulatory framework in place will not be met as a notification under Directive 2015/1535 implies a mandatory standstill period of at least 3 months.
The Bill is expected to be signed into law and published shortly. It will enter into force 10 days following its publication in the Belgian Official Journal, with the exception of specific provisions that will start to apply at the latest on 31 January 2020.
