Is it legal to provide free samples of medicines?

• Compliance/Data Protection/ESG
• LifeSciences

Providing free samples of medicinal products by pharmaceutical companies to healthcare professionals (HCPs) may allow HCPs to become familiar with such medicines and gain experience with their use in practice. Samples of medicines provide information to HCPs and may serve a promotional function. However, there is a high risk that sample packages of medicinal products may be used to unduly influence HCPs. That is why a lot of countries impose strict requirements for providing medical samples to HCPs, while some of countries even prohibit the sampling of medicinal products as such. At the same time, some countries allow providing samples of medicines to the general public (patients) subject to certain conditions.

General European approach

In the European Union, the supply of medicines samples is considered to be a type of advertising of medicinal products.

EU legislation

According to the EU legislation (in particular, EU Directive 2001/83/EC), free samples shall be provided on an exceptional basis only to persons qualified to prescribe them if a number of conditions are met, e.g.: the number of samples for each medicinal product each year on prescription shall be limited; any supply of samples shall be in response to a written request, signed and dated, from the prescribing agent; etc. In any case no samples of medicinal products containing psychotropic or narcotic substances may be supplied. EU member states may also place further restrictions on the distribution of samples of certain medicinal products.

EU court practice

According to the EU court practice (in particular, the Judgment of the Court of Justice of the European Union dated 11 June 2020) it is prohibited for pharmaceutical companies to provide free samples of prescription-only (Rx) medicines to pharmacists. Thus, only doctors may receive sample packages of Rx medicines. However, this does not preclude distributing free samples of non-prescription (OTC) medicinal products to pharmacists.

Code of Practice of the European Federation of Pharmaceutical Industries and Associations (EFPIA)

Pursuant to the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (EFPIA), each healthcare professional (HCP) may receive, per year, not more than 4 medical samplesof a particular new medicinal product he/she is qualified to prescribe for 2 years after the HCP first requested such samples (i.e. the “4×2” standard). The EFPIA Code contains a number of rules for determining whether a particular medicinal product may be considered new or not, as well as requirements for HCPs’ requests for medical samples.

Further, each sample of a medicinal product must not be larger than the smallest presentation of that particular medicinal product in the relevant country. Each such sample must be marked “free medical sample – not for sale” (or similar words) and must be accompanied by a copy of the summary of product characteristics.

Moreover, companies must have adequate systems of control in place and accountability for medical samples which they distribute and for all medicinal products handled by their medical sales representatives. This system must also clearly establish, for each HCP, the number of medical samples provided.

In any case it is prohibited to give samples of medicinal products as an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicinal products. Further, medical samples must not be given for the sole purpose of treating patients. Lastly, sampling of medicinal products containing psychotropic and narcotic substances is prohibited.

Swiss approach: providing samples of medicines to HCPs and general public

Similar to the European approach, providing free samples of medicines in Switzerland is considered to be a type of advertising of medicinal products. In our blog Advertising of medical products to the public and healthcare professionals (HCPs): how to minimize risks? we described the Swiss general requirements for advertising of medicinal products to the public and healthcare professionals.

Both the Swiss legislation and the Swiss self-regulatory code of conduct (so called Pharma Code) provide for a number of specific requirements for sampling of medicinal products. For instance, rules regulating medicines sampling as a type of advertising addressed to HCPs differ from those ones governing providing samples of medicines to the general public.

In particular, samples of medicinal products intended for HCPs may only be distributed in small numbers per medicinal product, per year and per healthcare professional. They may only be provided upon the initiative of the HCPs and at their written requests. The sample pack must correspond to the smallest authorised pack size, as well as be clearly and permanently labelled as a “free sample”. It must contain the required information and text on the container and packaging material, as well as an authorised package leaflet. The sample pack must be accompanied by the medicinal product information most recently authorised by Swissmedic or a relevant reference to its publication. Samples may not be given as an inducement to recommend, prescribe, acquire, deliver, sell or administer a particular medicinal product. Companies must ensure that all necessary records are kept regarding providing sample packs of medicinal products. 

According to the Swiss legislation, in certain cases sampling of medicinal products may be also used as a type of public advertising addressed to the general public (i.e. patients) subject to a number of requirements. In such cases samples of medicinal products for the public may only be given free of charge and must be clearly visible and permanently labelled as “free samples”. They must comply with the Swissmedic requirements for information and texts on packages. Such samples of medicinal products shall not contain more than one recommended daily dose. Moreover, samples of certain categories of medicinal products must not be offered for self-service and may only be dispensed to the public by corresponding dispensing points.

Recommendations

It is strongly recommended:

• Before providing samples of medicinal products, to ensure compliance of such sampling with all requirements of applicable laws, relevant self-regulatory organizations’ codes of conduct and local law enforcement practices;
• To develop internal compliance documents of the company (e.g. a policy, SOP) and train employees, who are interacting with HCPs and engaged in advertising medicines, to ensure full compliance with the regulations that apply to providing examples of medicinal products;
• To ensure that all necessary documents and other records are kept regarding providing sample packs of medicinal products.