Małgorzata Kubacka
Polskie regulacje prawne rynku farmaceutycznego od 1918 roku
2020-10-21
Obecnie obowiązujące instytucje prawne sankcjonujące ochronę zdrowia publicznego w obszarze farmacji nie są nowe – wiele z nich kształtowało się w Polsce przez ostatnie 100 lat. Ich rozwój był szczególnie widoczny w okresie dwudziestolecia międzywojennego, kiedy powstawały podwaliny rozwiązań prawnych stosowanych po II wojnie światowej. Równolegle zmiany zachodziły w przepisach karnych, które chroniły normy szczegółowe – od pozaborczych kodeksów karnych, poprzez Kodeks karny Makarewicza, aż po pozakodeksowe prawo karne. Nasze współczesne Prawo farmaceutyczne to nie tylko wynik implementacji dyrektyw unijnych, ale także naszych własnych, polskich doświadczeń w zakresie regulacji szeroko pojętej ochrony zdrowia publicznego, a ściślej – bezpieczeństwa farmaceutycznego.
Słowa kluczowe: farmacja, ochrona zdrowia publicznego, Prawo farmaceutyczne, pozakodeksowe przepisy karne.
© Farm Pol, 2020, 76(9): 509–518
Polish legal pharmaceutical market regulations since 1918
The currently applicable legal institutions sanctioning the protection of public health in the field of pharmacy are not new – many of them have been established in Poland over the last 100 years ago. Their development was particularly visible in the interwar period, when the foundations for legal solutions applied after World War II were laid. Many legal institutions are still in use today, such as the marketing authorization, the authorization to establish a pharmacy, and quality control of the drugs on the market and many others. It can be observed evolution of legal definitions like: medicinal product, patient, marketing authorization holder. A few definition disappeared – like decayed or counterfeit medicinal product. On the base of general regulations of pharmaceutical market after years new legal acts were created like Act on counteracting drug addiction or Act on medical devices. There have been major changes to the criminal law. Initially, a violation of the legal provisions regarded to the production, trading or running of pharmacies and others referred to the currently applicable penal codes - until 1932 these were three post-partition codes – Russian, German and Austrian penal law. From 1932 it was adopted the Polish Penal Code, known as “Makarewicz Code”. It was not until 1951 that criminal provisions appeared in the Act of pharmacies, and since then non-code criminal law was created in the field of pharmacy. Some solutions have appeared quite recently – it can be included the requirement to conduct clinical trials before applying for marketing authorization of a medicinal product to the market or the institution of target import to save the patient’s life and health. Pharmaceutical supervision in the form of the Pharmaceutical Inspection is also a result of the entry into force of the Act of 1991. Our modern pharmaceutical law is not only the result of the implementation of EU directives, but also our own Polish experience in the field of regulation of the broadly understood protection of public health, and more precisely – pharmaceutical safety.
Keywords: pharmacy, public health protection, pharmaceutical law, penal provisions outside the criminal code.
© Farm Pol, 2020, 76(9): 509–518