Planned changes in the pharmaceutical law – who and where will be able to open a pharmacy?

On 7 December 2016 the Sejm (lower house of the Polish Parliament) has received another draft amendment of the Act of 6 September 2001 Pharmaceutical Law, which provides significant changes to the right of establishment of pharmacies with regards to the their number in a given area, the distance from other pharmacies or the form of business activity.

The draft provides, inter alia, that permission to open a pharmacy will only be granted to:

  • pharmacists with the right to practice the profession, who run a sole proprietorship, and
  • partnership or general partnership whose core activity is solely operation of pharmacies and in which partners are only pharmacists with the right to practice the profession.

It is also planned to limit the number of pharmacies run or controlled by one pharmacist or a company to a maximum of 4. The amendment also imposes demographic and geographical restrictions, which involve, among others, granting permission to open a pharmacy dependant on whether on the day of request the number of inhabitants in a given municipality per one pharmacy is at least 3,000 people. Pharmacies should be at a distance of at least 500 meters in a straight line from each other.

The draft of the Act is motivated, inter alia, with negative phenomena currently occurring in the pharmacy market which carry the danger of monopolisation of the market of pharmaceutical services by the chains of pharmacies that are linked to or are dependent on pharmaceutical wholesalers and therefore lead to the marginalisation of pharmacists who run individual pharmacies. In the reasons for the draft there was also a reference to the illegal practice, the so-called ‘reversed chain of medicines distribution’ which consists in obtaining medicines in order to export them to other countries.

On the one hand, changes are guided by a concern for national pharmacists, the availability of medicines and increase of market control. On the other hand they raise doubts as to their effect on the competition in the market of pharmaceutical services. There are, among others, comments that entry into force of the regulation may deepen the disparities in the distribution of pharmacies, limit access to pharmaceutical services and even perpetuate the irregularities in the pharmaceutical market (such position was presented by the Lewiatan Confederation).

It is also questionable whether the planned changes, in particular the introduction of the demographic and geographical criteria does not violate the EU principles of freedom of establishment (cf. the regulations of the pharmaceutical market in the EU countries and the freedom of establishment).

The draft is currently at the stage of first reading in the committees.

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