Draft Act dated 6 September 2001 Pharmaceutical law (Journal of Laws of 2001, item 1381), to improve access to medicines, proposes a solution that can disrupt the market and facilitate criminal activities.
The Ministry of Justice wants to make it possible to donate drugs free of charge to hospitals, children's homes or victims of natural disasters. However, the proposed changes were designed in such a way that pharmacies could not pass on medical advice to the institutions in need, but they would have the right to issue them without restriction to individuals.
On the one hand, to the mentioned provision raise a number of controversy, with second And the interpretation according to which the pharmacy could issue prescription drugs without a prescription seems to be wrong. The provision is silent on this subject and should therefore be read in the light of the entire regulation of pharmaceutical law, which clearly governs the rules on the issue of medicines.
The medicinal product is to reach the person in need
A number of controversy sparks Article 86a pharmaceutical law, which would provide that "except in the cases referred to in the Act, a retailer may dispose, including free of charge, of a medicinal product for the sole purpose of supplying the population directly". While it is very important to say "to supply the population directly", it would mean that it would be risky to transfer the products to hospitals, social assistance houses or children's homes, because it is difficult to talk about directness when transferring the product to the institution.
The Article in question would not apply if there were an exception in the Act which regulates the rules on the issue of medicines.
In a situation where the proposed changes would be adopted in practice, the pharmacist could issue medicines for a fee other than the refund bill or even issue medicines without asking the patient for a prescription.
Given that the pharmacy could systematically issue an unspecified amount of medicines to patients, the state authorities would lose control of the market. Such a mechanism could easily lead to the export of medicines, and if the patient was caught, the pharmacies would not have any consequences.
On the one hand, to the mentioned provision raise a number of controversy, with second And the interpretation according to which the pharmacy could issue prescription drugs without a prescription seems to be wrong.
The provision is silent on this subject and should therefore be read in the light of the entire regulation of pharmaceutical law, which clearly governs the rules on the issue of medicines. This position was expressed by the Ministry of Justice, while admitting that there was no precision in the design of the regulations.
The Resort has announced that this provision will still be modified. A list of situations likely to fall within the definition of "direct public supply" will be established. These will include cases of drug donation to children's homes, hospices or natural disasters.
It would be appropriate to control the state authorities when giving medicines to all kinds of institutions. Yes, to prevent the formation of seeming welfare homes.
Risk of price dumping
Another concern among pharmacists is the possibility of developing online pharmacies. The adoption of this Article could lead to price dumping. Under current pharmaceutical law, advertising of pharmacies is prohibited. After the amendment, many pharmacies could make promotions on a "buy" basis one a second you will receive free of charge’.
The proposed amendment of the Justice Resort is already 11 attempt to reduce the export of medicines taken in recent years 5 years.
Author:
Patrycja Łepkowska
Junior Legal Consultant – Tax. She graduated from the Faculty of Law at the Leon Kozminski Academy and from the American Law Center at the Faculty of Law and Administration at the University of Warsaw, in cooperation with Georgia State of University and Emory Law School.
With Chancellery Russell Bedford tied since October 2017, where it handles economic operators in international tax planning.
Previously, she gained her professional experience in Warsaw law firms, where she participated in projects in the fields of economic, commercial and civil law, as well as in the Helsinki Human Rights Foundation under the "Human Rights and Taxes" Klink Programme.