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CJEU confirms ban on free samples of prescription-only medicines to pharmacists | bnt attorneys in CEE
In June 2020, the CJEU ruled that free samples of prescription-only medicines cannot be distributed to pharmacists. However, national pharma legislation shall allow the provision of free samples of over-the-counter (OTC) medicines to pharmacists.
The CJEU confirmed that Article 96 of Directive (EU) No. 2001/83/EC bans the supply of free samples of prescription-only medicines to pharmacists, since pharmacists do not belong to the category of persons qualified to prescribe medicinal products. However, Article 96(2) of the Directive allows Member States to place further restrictions on distribution of samples. Thus the local rules slightly differ.
According to Hungarian law, free samples of prescription-only medicines and OTC medicines can be provided to pharmacists. However, this is limited to a maximum of two packaging unit free samples each year. No free sample can be provided from medicines in a subsidy category higher than 0% after the end of the year following start of the sale of a medicinal product in Hungary.
Similarly, in the Czech Republic free samples of registered medicines (both prescription-only and OTC) can be provided to persons authorized to dispense such medicines, so also to pharmacists. Samples must be labelled in line with applicable law, and samples are allowed only in limited quantities and only upon a written request from a pharmacist.
In Poland samples may be provided exclusively to HCPs, but not to pharmacists. Also, there is no differentiation between prescription medications and OTC drugs, in terms of samples. Documentation duties include requiring that an HCP requests samples in writing before receiving them from the merchandiser, and must keep a ledger of samples handed out.
In Slovakia, too, free samples can be provided only to someone entitled to prescribe medicines, based on a written request from the receiver in a maximum amount of two packages a year of the smallest packaging available.
Next, in Bulgaria, free samples of medical products can be provided as an exception only to medical specialists entitled to issue prescriptions. So, pharmacists cannot receive free samples of medicinal products irrespective of whether these require a prescription or not. No more than two samples of the same medical form of a medicinal product can be provided during a calendar year. Holders of marketing authorization must maintain a system on reporting and control of all samples distributed.
In Latvia free samples can be handed over only to persons who have the right to prescribe the specific medicinal product, so pharmacists cannot get free samples. In addition, a written request signed and dated by a medical practitioner or the head of a medical institution is needed. This applies to both OTC and prescription medicines.
Everyone entitled to prescribe a particular medicinal product can get a maximum four free samples of the same prescription medicine each year, but no more than 1000 free samples of the same prescription medicine a year can be provided by the distributor.
In Lithuania, promoters of medicinal products can provide free samples to persons qualified to prescribe them. Additionally, free samples cannot be handed over to HCPs with the aim of handing them further to pharmaceutical specialists or members of the public or to use them for health care purposes. Thus no difference is drawn between OTC and prescription-only medicines. However, these legal provisions would have to be interpreted according to EU law.
Likewise in Estonia supplying samples of medicinal products to persons not qualified to prescribe them is also banned. No difference is drawn between OTC and prescription-only medicines. No samples of medicinal products containing narcotic drugs and psychotropic substances or antibiotics may be supplied to anyone. One person may be provided with up to five samples and the number of samples provided each year must not exceed 300.
Consistently, in these CEE countries samples can only be provided in the form of the smallest packaging put on the market, labelling obligations must be kept and strict documentation requirements apply. Samples of drugs containing psychotropic or intoxicating substances are generally prohibited.
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