Provisions for the Integrated System for Monitoring the Circulation of Medicinal Products (ZSMOPL) were introduced by the Pharmaceutical Law Amendment Act of April 9, 2015.
Provisions for the Integrated System for Monitoring the Circulation of Medicinal Products (ZSMOPL) were introduced by the Pharmaceutical Law Amendment Act of April 9, 2015. The statutory obligation for pharmaceutical entities to report via the system will take effect on April 1, 2019.
ZSMOPL – the purpose of the system
The designed system (ZSMOPL) is intended to provide the General Pharmaceutical Inspectorate with tools to monitor the status and transactions related to medicinal products, products for special nutritional use and medical devices that are at risk of unavailability in the territory of Poland. In addition, the obligation to report through ZSMOPL is also intended to counteract the export of reimbursed medicines from the country, which causes financial losses to the state budget. In short, the imposition of reporting obligations on pharmaceutical market participants is expected to lead to uninterrupted and unthreatened access of Polish patients to important medicinal products, products for special nutritional purposes and medical devices.
The purpose of creating and implementing such a system is good by design. Why, then, is this law causing justifiable agitation among many entities operating in the pharmaceutical industry? The devil is in the details – in this case, in the scope of the subject of the reporting obligation, the scope of data to be provided and the frequency of reporting.
Entities required to report
The law imposes reporting obligations on, among others, responsible entities and pharmaceutical wholesalers. At the same time, it does not differentiate the obligation of these entities in terms of the type of medicinal products they manufacture or trade. Instead, the definition of a medicinal product, according to the Pharmaceutical Law, is very broad. Therefore, the reporting obligation also applies to entities that manufacture or trade in non-prescription drugs and homeopathic medicinal products.
Thus, one can already imagine the amount of completely redundant data that will be reported to ZSMOPL every day (after all, the reporting obligation is daily, regardless of whether any transaction, stock transfer or batch release of a medicinal product occurred on a given day). Data on ordinary painkillers, preparations containing, for example, magnesium (which are medicinal products), or any homeopathic drugs – these data will also be subject to daily reporting. The importance of these products for the protection of health and life of Polish patients, together with the potential risk of their unavailability on the market and the consequences of their absence, is incomparably less than in the case of medicinal products on the list of those at risk of unavailability (such as insulin or certain vaccines).
The scope of data covered by the obligation to report to ZSMOPL
In this case, the problem concerns, on the one hand – the (in)intentional inaccuracy in the wording of the regulations, and on the other – the imposition of an obligation to report data, constituting company secrets, which do not serve the purpose of implementing ZSMOPL.
We are talking, first of all, about the obligation of all obliged entities to report data on the number of unit packs transacted and stock transfers (Article 72a(2)(2) of PrFarm). The law does not limit this obligation to data on transactions or transfers within the territory of Poland. Literally, therefore, obligated entities are required to report every sale and every warehouse transfer, regardless of whether it takes place in Poland. Leaving aside the enormous amount of data that entities will have to provide to ZSMOPL in this regard, the obligation to report transactions and transfers taking place exclusively abroad (e.g., between a foreign responsible entity and its foreign recipient, for a medicinal product authorized for marketing and also sold in Poland by that responsible entity) dangerously encroaches on economic freedom and corporate secrecy. This raises the question of the advisability of the General Pharmaceutical Inspector collecting and processing data on foreign transactions.
The Act also requires reporting on the net value of unit packs disposed of without taking into account discounts, rebates and rebates (Article 72a(2)(3) of PrFarm). The advisability of reporting financial data through ZSMOPL is rather questionable. Given the purpose of the introduction of ZSMOPL, such an obligation seems unnecessary, to say the least. It is also not insignificant that the provision does not specify whether it is the net value of packages disposed of by a given entity in Poland or also in other countries. There may therefore be a significant amount of sensitive financial data collected by the General Pharmaceutical Inspector regarding pharmaceutical companies. If this data is not properly secured, pharmaceutical market participants will be exposed to the risk of disclosure of company secrets and, arguably, severe sales and financial consequences.
Summary
As always, the rule that first and foremost the voices of the most interested parties – in this case, those in the pharmaceutical industry or pharmacists’ associations – should be heard when creating new regulations proves true. The environment agrees in principle with the introduction of the system and supports the arguments of the authors of the amendment regarding the need to monitor the market to a certain extent. However, it rightly calls for the specifics of the pharmaceutical industry to be taken into account, in particular the exclusion of certain types of medicinal products from the reporting obligation, the elimination of the obligation to report the net value of disposed packages, and the reduction of the reporting frequency from daily to biweekly, for example. Unfortunately, so far, the above demands have not seen proper changes in the regulations.
Przedawnienie odpowiedzialności członka zarządu za zobowiązania spółki jest zagadnieniem złożonym. Przede wszystkim wynika to z tego, że przepisy regulujące tę materię są zawarte w co najmniej trzech aktach prawnych: w Kodeksie spółek handlowych (art. 299), który w zakresie przedawnienia należy czytać łącznie z Kodeksem cywilnym, w Ordynacji podatkowej (art. 116 i 118) i w ustawie o finansach publicznych (art. 66b).
