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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
The Ministry of Heath has a pharmacovigilance service that hears complaints for defective medicinal products. Such complaints can be filed by anybody.
The ministry suspends or withdraws the marketing authorisation of a medicinal product when it appears that:
- the medicinal product is harmful under normal conditions of use;
- the therapeutic effect is lacking; or
- the medicinal product does not have the declared qualitative or quantitative composition.
The Ministry of Health appoints an expert commission whose mission is to provide reasoned opinions on applications for marketing authorisation of medicinal products and, if appropriate, submit proposals for suspension or withdrawal of such marketing authorisations.
What data protection issues should be considered when conducting pharmacovigilance activities?
All data protection requirements are now specified in the Act of 1 August 2018 on the organisation of the National Commission for Data Protection and implementing the EU General Data Protection Regulation (2016/679).
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
Yes – see Grand Ducal Regulation of 1 December 2011 on the criteria, conditions and procedure for the pricing of medicinal products for human use (as modified).
In Luxembourg, the minister in charge of social security policy decides on prices for all products which are considered and defined as ‘medicinal products’.
A request should be filed to the Ministry of Social Security via a form to fill out specifying the official prices in the country of origin and the prices requested in Luxembourg.
Marketing authorisation holders are authorised to commercialise a product only after having received the approval of the price by the minister.
As most products covered by health insurance are imported from Belgium, the public prices practiced in Luxembourg are directly derived from Belgian retail prices.
What is the structure for state reimbursement of medicinal product costs?
In principle there is no relationship between pricing and reimbursement. However, in practice, the Ministry of Social Security sets out a positive list and, based on this list, the National Health Fund will decide whether to reimburse. The normal rate of reimbursement in Luxembourg is 80% of the public price. The healthcare system works on a reimbursement basis whereby you submit receipts for consultations, treatment and medicines to the National Health Fund for reimbursement at the appropriate rate, which varies between 80% to 100%.
Since 1 October 2014, pharmacists must inform their patients that a generic drug is on the market. The generic product is substitutable and belongs to a group of alternative drugs. The substitutable drugs are listed by the National Health Directorate. Based on this list, the National Health Fund fixes for all alternative products the basis of reimbursement and set reference amount on which the participation of the patient is established. If the patient refuses the generic product, they must pay the difference that is not supported by the National Health Fund.
The list of all the groups of medicinal products subjected to a reimbursement is published in the Official Journal (www.legilux.lu).
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