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:
- constitute one separate whole and be equipped with a warehouse or expedition cabinets;
- be equipped with a fitting room – in relation to the entity's premises performing medical products made to order;
- be equipped with an dispatch room - in relation to the premises of an entity other than those specified in point 2;
- enable free access to beneficiaries, in particular disabled people with musculoskeletal dysfunction;
- provide a place to wait;
- 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;
- walls and floors should be smooth and easily washable;
- 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
The draft of the new regulation on the one hand systematises the issue of specific requirements regarding the supply of medical devices – separate paragraphs are devoted to premises dealing with the supply of specific medical devices, for example in the fields of hearing prosthetics or spectacle optics. On the other hand, however, the operations of such entities have been significantly hindered – further requirements have been imposed, which in some cases raise considerable doubts. The first requirements concern strictly of the building or part of it where the premises of the entity performing activities in the field of supply of medical devices available on prescription are located. Such a building must meet the requirements for public utility buildings regarding the technical conditions to be met by buildings and their location – meaning that such buildings must meet the relevant requirements specified in technical and construction regulations. The second requirement is to enable free access for beneficiaries, in particular people with motor disabilities, by providing paved approaches to the building and communication spaces within the building where the premises are located that are free from horizontal and vertical barriers, or in their absence, the installation of devices or the use of technical measures and architectural solutions that enable access to the premises – this is, in a sense, a detailing of the current § 1 item 4 of the regulation. The third requirement is appropriate signage 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 § 1 of the currently binding regulation already discussed, however, significant changes have been made here: "The premises of the entity performing activities in the scope of supplying medical devices available on prescription:
- 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 needs to be broken down into its constituent parts and the most important issues discussed. Firstly, the draft refers to an entity performing activities in the scope of supplying medical devices available on prescription – 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 devicesThus, the dichotomy that we observe in the currently binding regulation disappears. What follows from this? Among other things, the fact that pharmacies will also be subject to the obligation having a fitting roomHowever, is this practically possible? Very often, the idea of creating a separate room or carving out a sensible area within the premises to establish such a place will simply prove unnecessary, and even impossible to implement. Pharmacies are very frequently operated in genuinely small premises, and therefore, simply due to having a very small area available to customers, it is simply not possible to create such a fitting room. Subsequent paragraphs of the ordinance set out additional requirements for the premises of entities performing activities within the scope of the supply of medical devices available on prescription in the fields of hearing acoustics or spectacle optics. This helps to avoid a certain confusion that occurs in the currently binding § 1 of the ordinance, which lists together all the requirements that apply to individual entities. In accordance with § 6 of the draft, an entity performing activities within the scope of the supply of medical devices available on prescription shall adapt the premises where the supply is carried out to the requirements of the ordinance within 12 months from the date of entry into force of the ordinance. And in accordance with § 8, the ordinance enters into force on 1 January 2024 – meaning that by 1 January 2025, every entity performing activities within the scope of the supply of medical devices available on prescription is obliged to adapt its premises to the requirements presented in this ordinance.
How to evaluate a new project?
When assessing the draft regulation solely in terms of its systematics, it must be considered a positive amendment to the regulation – it is certainly much more legible and clearly assigns specific requirements to particular entities. However, the abandonment of the division into entities that perform activities within the scope of the supply of medical devices and entities that they make medical products made to order. It is indisputable that an entity which solely distributes medical devices need not be obliged to fulfil many conditions that only make sense in the case of the actual making or manufacturing of medical devices. Made-to-order devices are a kind of individual product, made for a specific patient – and therefore in this case it is entirely justified to separate out a certain room or part of the area to create a fitting room in order to ensure the patient's privacy, for example when trying on prosthetics, wigs, etc. And what about very small pharmacies – especially local ones, which incidentally In the ministry's narrative, are they a priority entity under protection? It is precisely such entities that will be most vulnerable when the draft regulation comes into force. In very small towns, pharmacies are run in small premises where the space available for patients frequently allows only a few people to be present at the same time, and where on top of that is one supposed to find space for a fitting room? This is a genuinely major problem that must be recognised as part of subsequent work on the draft regulation. According to the log of amendments made available on the Government Legislation Centre website, the draft is currently at the public consultation stage – therefore, by the end of July we should learn the positions of all entities that agree with the planned amendment or have any comments and reservations. It is worth emphasising that this regulation does not affect in any way the validity or scope of application of the regulation on the basic conditions for running a pharmacy. These are two separate regulations governing different subject areas. The regulation on the basic conditions for running a pharmacy applies to all entities running pharmacies – whereas the regulation discussed in this article applies to entities (not only pharmacies) that carry out activities within the scope of supplying medical devices available on prescription or manufacture custom-made medical devices. The changes discussed above have not yet come into force, but it is worth getting acquainted 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.