On the Possibility of Returning Medicinal Products to a Pharmacy

August 8, 2019

BRACE Law Firm ©

Is it possible to return a purchased medicinal product to a pharmacy? The answer to this question involves various aspects depending on the specific situation, taking into account the provisions of current legislation on consumer rights protection and the circulation of medicinal products.

As a general rule established by consumer protection legislation, a buyer may return goods of proper quality if they do not fit in shape, dimensions, style, color, size, or configuration. However, due to the specific nature of the goods sold (medicinal products), this rule does not apply to this type of product. Consequently, the possibility of returning purchased medications is subject to several restrictions.

To accurately define such cases, let us first consider the legal acts that regulate the return of medicinal products. In addition to the general norms established by Law No. 2300-1 dated February 7, 1992, On Consumer Rights Protection (the "Consumer Rights Protection Law"), legislation on the circulation of medicinal products regulates consumer rights protection in the sale of medicinal products. Article 25 of the specified regulatory act implies that returns of goods of proper quality are permitted, except for goods included in the relevant list of goods not subject to exchange or return. Decree of the Government of the Russian Federation No. 55 dated January 19, 1998, approved the List of Non-Food Goods of Proper Quality Not Subject to Return or Exchange for Similar Goods of Other Size, Shape, Dimension, Style, Color, or Configuration (the "List"). Medicinal products appear in the first paragraph of the specified List.

It is important to note that modern pharmacies sell medical devices and so-called associated goods in addition to medicinal products. All of the above goods are included in the specified List. Specifically, items for the prevention and treatment of diseases at home (sanitation and hygiene items made of metal, rubber, textiles, and other materials; medical instruments, devices, and apparatus; oral hygiene products; eyeglass lenses; childcare items), medicinal products, and personal hygiene items (toothbrushes, combs, and other similar goods) are not subject to exchange or return.

Questions also frequently arise regarding the possibility of returning Dietary Supplements. To answer this question, it is necessary to understand exactly what the legislator means by Dietary Supplements. Under Federal Law No. 29-FZ dated January 2, 2000, On the Quality and Safety of Food Products, Dietary Supplements mean natural (identical to natural) biologically active substances intended for consumption simultaneously with food or for introduction into the composition of food products. Furthermore, Dietary Supplements are classified as food products. The specified regulatory act establishes that food products consist of products in natural or processed form consumed by humans as food, bottled drinking water, alcoholic products, non-alcoholic beverages, chewing gum, as well as food raw materials, food additives, and Dietary Supplements. According to a literal interpretation of Article 25 of the Consumer Rights Protection Law, the right to exchange and return goods of proper quality applies to non-food goods. Pursuant to Article 2 of the Federal Law, food products are products in natural or processed form in circulation and consumed by humans as food (including baby food and dietetic food), bottled drinking water, alcoholic products, beer and beverages based on it, non-alcoholic beverages, chewing gum, food additives, and Dietary Supplements. Thus, the buyer's right to return goods under the Consumer Rights Protection Law does not apply to Dietary Supplements if they are of proper quality.

This leads to the conclusion that almost all goods dispensed by pharmacies, including medicinal products, medical devices, and Dietary Supplements, are not eligible for exchange or return if they are of proper quality. Therefore, it is important to note that returning medicinal products of proper quality on the grounds that the product did not suit the buyer is impermissible. Nevertheless, the Consumer Rights Protection Law establishes the possibility of returning or exchanging a substandard medicinal product. This right is secured for all types of goods, including those included in the List.

Based on the legal norms cited above, and by virtue of Article 18 of the Consumer Rights Protection Law, upon discovering that purchased medicinal products are substandard, the buyer may, at their discretion, present the following demands to the pharmacy:

• demand replacement with the same medicinal product of proper quality (the same brand);
• demand replacement with a medication of a different brand with a corresponding recalculation of the purchase price (it is extremely important to consider the possibility of using an alternative (interchangeable) medicinal product, including contraindications and individual intolerance);
• refuse to perform the sales contract and demand a refund of the amount paid for the medicinal product. In this case, at the seller's request and expense, the buyer must return the defective medication. However, in practice, such a return is not always feasible in a short timeframe if the buyer conducts an expertise regarding the quality of the medication. As a general rule, the seller must pay for the expertise. However, in the event of a conflict between the parties, the buyer may independently conduct the expertise and subsequently recover the costs of such research from the pharmacy if the medication proves to be substandard or falsified.

It should also be noted that a sold medicinal product or any other product with an expired shelf life is also considered substandard.

In some cases, proving violations of quality requirements for a purchased medication may prove quite difficult. Proving becomes easier if the pharmacy sold the medicinal product after its shelf life expired or if the medication does not match the prescription. In the first case, returning the medicinal product is possible even if the production date is missing from the packaging. In the latter case, a general rule exists, with some exceptions [1], according to which the pharmacy returns the prescription to the person purchasing the medicinal product with a corresponding notation (Order of the Ministry of Health of Russia No. 403n dated July 11, 2017, On Approval of the Rules for Dispensing Medicinal Products for Medical Use, Including Immunobiological Medicinal Products, by Pharmacy Organizations and Individual Entrepreneurs Holding a Pharmaceutical License). This allows for a comparison of the information specified in the prescription with the actually purchased medication. There is a high probability of a successful return of a medicinal product if the pharmacy sold a prescription-only medication without one. In general, such actions by the seller constitute a serious administrative offense, which can serve as a weighty argument when returning such a medicinal product, even if its quality meets statutory requirements. The situation becomes significantly more complicated if the defects in the medicinal product are not obvious, but the buyer suspects it is substandard. Undoubtedly, with the gradual introduction of labeling for medications, it will become somewhat easier for the buyer to check a medicinal product for its "legality". However, under Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products"), quality criteria for medications include, among other things, compliance with the requirements of the pharmacopoeial monograph and regulatory documentation. Thus, proving that a product is substandard, in the absence of the obvious violations mentioned above, may require the involvement of a specialist or expert (expert organization) in this field.

Proving may also be difficult if the pharmacy dispenses a medicinal product without a prescription and the pharmacist advised the buyer to purchase an unsuitable medication. In this case, it becomes extremely difficult to prove that the buyer's request was for a different medicinal product and that they described different symptoms for which the medication suggested by the pharmacist is impermissible. In such a situation, one may use evidence such as witness testimony. Alternatively, if the pharmacy has a website through which one can pre-order medicinal products and request information online, we recommend asking a written question regarding recommendations for purchasing a medicinal product and obtaining an answer that can form the basis of the evidence.

When purchasing a medicinal product, we recommend checking the integrity of the primary and secondary packaging, as discovering a breach of integrity later may create problems in proving when such a breach occurred (before or after purchase).

The Consumer Rights Protection Law establishes general timeframes for returning medicinal products. Specifically, the buyer may assert claims arising from the discovery that a medicinal product is substandard during its shelf life. If the buyer purchased a medicinal product with an already expired shelf life, Clause 2 of Article 447 of the Civil Code applies, according to which, if no warranty period is established for the goods, the buyer may assert claims related to defects provided they were discovered within a reasonable timeframe, but within 2 (two) years from the date of transfer to the buyer, or within a longer period if established by law or the sales contract. Based on these norms, the expiration of the shelf life at the time of purchase is not a basis for the seller to claim that the buyer's deadline for filing a return application has expired. Overall, we recommend checking the shelf life of a medicinal product directly at the time of purchase or as soon as possible thereafter.

It is important to note that, based on the provisions of Clause 5 of Article 18 of the Consumer Rights Protection Law, which also apply to medicinal products, and Article 493 of the Civil Code, the buyer's lack of a cash register or sales receipt, a cashless payment receipt, or another document certifying the fact and conditions of the purchase is not a basis for refusing to satisfy return demands. Nevertheless, we recommend retaining documents (receipts) confirming the purchase of medications to prevent bad-faith actions by the seller, such as denying the sale, which would complicate the return procedure. Additionally, when returning a medication, the buyer must provide the medicinal product itself in its full configuration (including primary and secondary packaging, instructions, etc.), the prescription for the medicinal product (if it is a prescription-only medication), and preferably a written application for the return of the medicinal product (if negotiations fail to resolve the conflict with the seller).

To protect their rights in the event of purchasing a substandard medicinal product, we recommend that the buyer take the following actions:

• upon discovering defects in the purchased goods, try to contact the seller as soon as possible with a request for a return or exchange;
• if the seller refuses to satisfy the demands, submit a written claim to the pharmacy in two copies, requesting a signature on one copy (to be returned to the buyer) acknowledging receipt. If the seller refuses to accept the claim, the buyer should send it to the pharmacy's legal address by registered mail. In addition to the claim, we recommend recording the appeal in the Book of Complaints and Suggestions, which must be freely accessible;
• if the buyer's demands remain unsatisfied, gather evidence for a court appeal (including conducting a quality expertise of the purchased medicinal product).

The pharmacy must satisfy demands for a return with a refund of the amount paid for a substandard medicinal product within 10 days from the date of the buyer's appeal.

The Consumer Rights Protection Law establishes the seller's obligation, upon the buyer's discovery of defects and a demand for replacement, to replace such goods within 7 days from the date of the demand. If the seller requires an additional quality check, the replacement may occur within 20 days from the date of the demand. If the seller does not have the necessary goods for replacement at the time of the demand, they must perform the replacement within 1 month from the date of the relevant appeal.

Thus, within the timeframes established above, the seller must either refund the funds paid by the buyer or replace the medicinal product with one of proper quality.

Nevertheless, the seller may refuse to satisfy the buyer's demands if there is a dispute as to whether the sold medicinal product met quality requirements at the time of transfer (provided quality is maintained within the warranty period, except for cases where non-compliance resulted from the buyer's violation of the rules for using the purchased medication). In other cases, the seller's refusal will be unlawful. In the situations described above, the buyer will face a rather long process of proving their case in court.

In the relationship between a pharmacy and a patient, the party selling the medicinal products must not engage in abuse. This especially concerns information about the medicinal products sold and the buyer's rights. However, in practice, due to legal ignorance, cases may occur where pharmacists unlawfully refuse to return or exchange substandard medicinal products.

According to the Rules for the Sale of Certain Types of Goods, the list of durable goods not subject to the buyer's demand for a free-of-charge replacement for the period of repair or replacement, and the list of non-food goods of proper quality not subject to return or exchange for similar goods of other size, shape, dimension, style, color, or configuration, approved by Decree of the Government of the Russian Federation No. 55 dated January 19, 1998, the seller of medicinal products must provide the buyer with accurate information such as: the name of the product; the location and name of the manufacturer and seller; the location of the organization authorized by the manufacturer to accept claims from buyers; information on product properties; rules and conditions for effective and safe use; the warranty period; the service life (shelf life); the price; information on the state registration of the medicinal product including the number and date of its state registration (except for medicinal products manufactured by the seller (pharmacy institution) according to prescriptions); and information on the number and date of the registration certificate for the medical device issued by Roszdravnadzor.

Furthermore, by virtue of Articles 8 and 10 of the Consumer Rights Protection Law, the seller must provide information on the rules for the sale of goods (including medicinal products). Such information must be brought to the buyers' attention in a clear and accessible form using methods adopted in specific service sectors, in the Russian language. In compliance with these legal norms, pharmacy organizations must establish a so-called "Consumer Corner", where the regulatory framework governing the buyer's rights and obligations is freely available.

According to the general rule established by the Law on Circulation of Medicinal Products, a commission of experts from an expert institution, appointed by its head based on an assignment issued by the authorized federal executive body, conducts the expertise of medicinal products. The head of the expert institution ensures the proper conduct of the expertise in accordance with the assignment and organizes the preparation of the commission's consolidated conclusion. By decision of the head, the commission may include experts not employed by the institution if their specialized knowledge is necessary and such experts are unavailable at the institution.

Only organizations that have received the relevant accreditation may issue such conclusions on the quality of medicinal products. To help buyers navigate the numerous expert organizations, we recommend consulting the official website of the Federal Accreditation Service.

The addresses of such laboratories are also available on the official website of the Roszdravnadzor.

Moreover, due to the critical importance of the pharmaceutical sector for public health, we recommend reporting suspicions regarding the quality of a medicinal product to the territorial Roszdravnadzor bodies in the place of purchase.

With the development of the pharmaceutical industry and the vast variety of medications, medical devices, and Dietary Supplements, problems related to the need for buyers to return goods purchased in pharmacies occur more frequently. Cases where buyers attempt to return medicinal products because they lack a clear understanding of which product best suits their indications are quite common. Slightly less frequent are precedents involving violations of quality requirements (for example, the sale of expired medicinal products, sale with damaged packaging, or sale of a medicinal product with incomplete configuration, such as missing instructions).

In practice, pharmacies are very reluctant to satisfy buyer demands for the return of medicinal products, even when legal grounds exist, as it is sometimes indeed difficult to determine whose fault caused the quality violations. Buyers, for their part, do not always timely identify even obvious defects in the purchased goods.

In this regard, we can conclude that disputes between buyers and pharmacy organizations are currently very numerous.

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References

1. [1] According to Clause 14 of the Rules for Dispensing Medicinal Products for Medical Use, Including Immunobiological Medicinal Products, by Pharmacy Organizations and Individual Entrepreneurs Holding a Pharmaceutical License, approved by Order of the Ministry of Health of Russia No. 403n dated July 11, 2017, the retail entity shall retain and store prescriptions (marked "Medicinal product dispensed") for:
   • narcotic and psychotropic medicinal products of Schedule II, and psychotropic medicinal products of Schedule III — for five years;
   • medicinal products dispensed free of charge or at a discount — for three years;
   • combined medicinal products containing narcotic drugs or psychotropic substances included in Schedules II and III of the List and manufactured in a pharmacy organization; medicinal products with anabolic activity; and medicinal products subject to subject-to-quantitative accounting — for three years;
   • medicinal products in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, and other medicinal products classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), and antidepressants (code N06A) not subject to subject-to-quantitative accounting — for three months.