Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Polish Pharmaceutical Law – Strenghts and Weaknesses 5 Years after Accession to the European Union. Analysis. ***

Anna Paulina Paul (Abschlußjahr: 2009)

Summary

Language: English

The Republic of Poland joined the European Union on 1 May 2004. This meant not only a huge change within old structures of the EU, but also a revolutionary adjustment of policies, legislation and economy in the new Member State. This thesis deals with a review of the situation related to the Polish pharmaceutical market as well as to its regulation and control five years after accession.
The basic national act on pharmaceuticals is the Pharmaceutical Law of 06/09/2001. This document is a complex legal act providing extensive provisions for most activities related to obtaining and maintaining a marketing authorization for medicinal products for human and veterinary use. It comprises provisions of several European Directives. The act regulates the scope of activities of administrative bodies directly involved in the marketing authorization process. Furthermore, it defines requirements for clinical trials, manufacturing and import, advertising and marketing of medicinal products, wholesalers, the operation of pharmacies and pharmaceutical inspection.
Even though the Pharmaceutical Law in its current form is a dynamic document attempting to meet the continuously changing requirements of the EU, it still contains a number of regulations seemingly different from the European idea. These divergences have been described bearing in mind national specifics, historical context and difficulties with national implementation of European legislation.

The central organ responsible for the assessment of registration dossiers is the Office for Registration of Medicinal Products, Medical Devices and Biocides (URPL). The Registration Office has been entitled by the Minister of Health to provide scientific services; however, the URPL has no decisive power in terms of marketing authorization of medicinal products which is a frequent reason for unnecessary delays in the process. The draft law on the Registration Office described in the thesis provides significant changes to the national registration system. The crucial change is the relocation of the complete decision making competency regarding medicinal products and biocides to a lower level: from the Minister of Health to the President of the Registration Office. According to the draft, the Registration Office will consequently become a central body of the government administration having a strategic character in the Health Care system at the national and European level.

In terms of medicinal products registered nationally before 1 May 2004, Poland committed to harmonize the complete pharmaceutical market with the requirements of acquis communautaire by the end of 2008. The harmonization can be beheld as a success of the Polish Health Care System and a huge step forward towards compliance with the EU-requirements.

Today, five years after accession, it can be said that Poland enriches the European Union with its scientific expertise. The Polish government managed to harmonize the complete Polish pharmaceutical market according to European standards providing herewith Polish patients access to safe and efficient therapies. The pharmaceutical industry can profit from a market with almost 40 millions patients who are guaranteed access to most innovative drugs. Differences in law and its interpretation result not from the lack of political and social readiness to implement the EU legislation as it is, but also from attempts to protect national industry, patients and regional distinctions with their long history.

Pages: 55