Fitting rooms in pharmacies – is it necessary or even possible? Discussion of the proposed requirements for the premises of entities supplying medical products

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Piotr Kłodziński|
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The pharmacy community is watching with astonishment the work on the draft of a new regulation of the Minister of Health on the detailed requirements that the premises of an entity carrying out activities in the field of supplying medical devices available on request should meet. The main problem is, among others, the planned obligation to organize fitting rooms in pharmacies. Will imposing such an obligation be feasible in practice?

We also invite you to read the previous blog entry on changes to the rules and conditions of operation of pharmacies (November 2022): New rules and conditions for running a pharmacy – how to adapt existing pharmacies to the new regulations?

Current legal status

Currently, there is a regulation of December 12, 2013 regarding detailed requirements for the supply of medical devices. Pursuant to this act, the premises of an entity performing activities in the field of supply of medical devices available on request must meet the following requirements:

  1. constitute one separate whole and be equipped with a warehouse or expedition cabinets;
  2. be equipped with a fitting room – in relation to the entity's premises performing medical products made to order;
  3. be equipped with an dispatch room - in relation to the premises of an entity other than those specified in point 2;
  4. enable free access to beneficiaries, in particular disabled people with musculoskeletal dysfunction;
  5. provide a place to wait;
  6. the storage conditions of medical devices should be in accordance with the manufacturer's recommendations, in particular they should ensure protection against confusion with other devices, mechanical contamination, weight loss, moisture and foreign odors;
  7. walls and floors should be smooth and easily washable;
  8. be equipped with a separate and adapted room for hearing testing - in relation to the premises of an entity performing activities in the field of hearing prosthetics.

Therefore, under the currently applicable regulation, pharmacies - as entities NOperforming medical devices – are not obliged to have a fitting room on the premises. As a rule, pharmacies offer medical products that do not have to be fitted to a given patient, which excludes the need to create such rooms or designate an appropriate area of the premises to create a fitting room.

Draft new regulation – systematization, but also making operations more difficult

On the one hand, the draft of the new regulation systematizes the issue of specific requirements regarding the supply of medical devices - separate paragraphs are devoted to establishments dealing in the supply of specific medical devices, for example in the field of hearing prosthetics or spectacle optics. On the other hand, the activities of such entities have been significantly hampered - further requirements have been imposed, which in some cases raise considerable doubts.

The first requirements apply strictly building or part thereof in which the premises of an entity performing activities in the field of supply of medical devices available on request are located. Such a building must meet the requirements for public buildings regarding the technical conditions to be met by the buildings and their location - i.e. such buildings must meet the appropriate requirements specified in technical and construction regulations.

The second requirement is to enable free access to beneficiaries, in particular disabled people with musculoskeletal dysfunction, by providing hardened, free from horizontal and vertical barriers to the building and communication spaces in the building in which the premises are located, and in the absence thereof, the installation of devices or the use of technical means and architectural solutions that enable access to the premises - this is, in a sense, a specification of the current § 1 point 4 of the regulation. The third requirement is an appropriate marking on the building, which must contain the following information:

  • name (company name) of the entity,
  • address and telephone number of the entity,
  • information on the hours of provision of services in the field of supply of medical devices - currently there is a requirement to provide information on working hours. Therefore, in such a case, it should be considered that if pharmacies offered the sale of medical products at hours other than the pharmacy's opening hours, it would be necessary to provide two different hours of service provision.

The next paragraph of the draft is a partial repetition of the already discussed § 1 of the currently applicable regulation, but significant changes have been made here:

"Premises of the entity performing activities in the field of supply of medical devices available on request:

  • constitutes one separate whole and is equipped with a warehouse or expedition cabinets intended for storing medical devices;
  • has a fitting room;
  • is equipped with an expedition table;
  • meets the conditions for storing medical devices in accordance with the manufacturer's recommendations, in particular in terms of ensuring protection against mixing these products with other devices, mechanical contamination, weight loss, moisture, and foreign odors;
  • has smooth and easily washable walls and floors;
  • is equipped with devices for measuring air temperature and room humidity.”

Now this provision should be broken down into its prime factors and the most important issues discussed.

Firstly, the project refers to an entity performing activities in the field of supply of medical devices available on request - therefore this concept includes de facto any entity (pharmacy, medical device store, etc.) that distributes medical devices. Therefore, it should be emphasized here that throughout the entire regulation there is no distinction between entities performing supply activities and entities producing medical devices. Therefore, the division observed in the currently applicable regulation disappears.

Hence? This includes the fact that an obligation will also be imposed on pharmacies having a fitting room. However, is this practically possible? Very often, the idea of creating a separate room or allocating a reasonable area in the premises to create such a place turns out to be simply unnecessary or even impossible to implement. Very often, pharmacies are run in really small premises, so due to the very small space available to customers, it is simply not possible to create such a fitting room.

The subsequent paragraphs of the regulation impose additional requirements on the premises of entities performing activities related to the supply of medical devices available on request in the field of hearing prosthetics or spectacle optics. This avoids the confusion that occurs in the currently applicable § 1 of the regulation, which lists all requirements that apply to individual entities.

Pursuant to § 6 of the draft, the entity performing activities in the field of supply of medical devices available on request will adapt the premises where the supply is carried out to the requirements of the regulation within 12 months from the date of entry into force of the regulation. And in accordance with § 8, the regulation enters into force on January 1, 2024 - i.e. by January 1, 2025, each entity performing activities in the field of supply of medical devices available on request is obliged to adapt the premises to the requirements set out in this regulation.

How to evaluate a new project?

Assessing the draft regulation in terms of its taxonomy, it should be concluded that this is a positive change to the regulation - it is certainly much more clear and clearly assigns data requirements to specific entities.

However, the abandonment of the division into entities that perform activities in the field of supply of medical devices and entities that they make medical products made to order. It is unquestionable that an entity that exclusively distributes medical devices does not have to be obliged to meet many conditions that only make sense in the case of the actual production or production of medical devices. Custom-made products are a kind of individual products, made for a given patient - so in this case it is most appropriate to separate a certain room or part of the area to create a fitting room in order to ensure privacy for the patient, for example when trying on prostheses, wigs, etc.

What about very small pharmacies – especially local ones? incidentally in the narrative, are ministries the priority subject to be protected? It is such entities that will be most exposed when the draft regulation enters into force. In very small towns, pharmacies are run in small premises, where the space available to the patient often allows for the simultaneous presence of several people, and where can you also find a place for a fitting room? This is a really big problem that must be noticed during subsequent activities on the draft regulation.

According to the register of changes available on the website of the Government Legislation Center, the project is currently at the stage of public consultations - so by the end of July we should learn the positions of all entities that agree with the planned amendment or have any comments or reservations.

What is worth emphasizing - this regulation does not in any way affect the validity or scope of the regulation on the basic conditions for running a pharmacy. These are two separate regulations that regulate different subject areas. The regulation on the basic conditions for running a pharmacy applies to all entities running pharmacies - while the regulation discussed in this article applies to entities (not only pharmacies) that carry out activities in the field of supplying medical devices available on request or that produce medical devices made to order. Currently, the changes discussed above have not yet come into force, but it is worth familiarizing yourself with the requirements that may or may not come into force.

 

If you have any questions or doubts related to this area of law, we cordially invite pharmacists and pharmacy owners to contact our Pharmaceutical Law Office.

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