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Licensing Guidelines and Regulations Posted 18/11/2013

First posted: 18 November 2013 

In 1999, a mandatory social health insurance scheme was established in Poland. In each of the 16 provinces, self-administering, regional sickness funds were set up; furthermore, sickness funds for certain professions were installed. This system proved to be inefficient and therefore the national health fund (Narodowy Fundusz Zdrowia, NFZ) under the control of the Ministry of Health(Ministerstwo Zdrowi)was established in 2003 [1]. The national health fund is a third-party payer in public health care. The basic source of financing for health care is income from healthcare contributions from personal income [2].

The services are provided free at the point of service in the case of sickness, injury, pregnancy, childbirth and confinement, as well as in prevention of diseases and health promotion [3].

Health care is available for the whole population. There is universal healthcare coverage for 99% of the population, and reimbursable medicines through the national health fund, although patients still have to pay a large share of their medicines costs out-of-pocket [4].

Poland has a low number of patent disputes between generics companies and originator companies. Between 2000 and 2007 there were fewer than 10 patent disputes from originator companies against marketing authorisations concerning the products of generics companies. However, patent litigation in Poland takes a very long time, with an average of between three and four years for disputes to be resolved, which significantly exceeds the EU average length of litigation of 2.8 years [5]. 

The average time interval between marketing authorisation and patient access to medicines is also quite long, with medicines only available on average 214 days after receiving marketing approval [6].

The National Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Rzeczpospolitej Polskiej, URPL), which was founded in 2001, is the governmental body responsible for the licensing of medicines in Poland [1, 3].

A generic medicine can be marketed in Poland six years after the first authorisation of the reference drug. This, however, is discordant with the harmonised ‘8+2+1’ period of exclusivity introduced in the EU. For Poland, data protection remains limited to six years for products authorised either through the mutual recognition procedure, the decentralised procedure or the national procedure [5].

The decision-making process for admission of medicines into the Polish market starts with submission for approval, in terms of the national registration procedure. The authorisation for admission into the Polish market is issued by decision of the Minister of Health but the accompanying documentation should be submitted in full to the URPL [2].

There is a fast-track procedure for reimbursement of generics in Poland. The fast-track procedure foreseen for generics seems to be very efficient and allows for a quicker generics uptake without a loss in quality [4].

The Ministry of Health makes an administrative decision on the basis of the report prepared by the president of the URPL. The set of documents required in order to start the registration procedure is set out in the Pharmaceutical Law for both innovative and generic drug products and is detailed in full in a directive of the Ministry of Health. Generic medicine registration demands the outcomes of bioequivalence tests [2].

If a mutual recognition procedure or decentralized procedure of registration is relevant, the URPL is responsible for harmonisation of central and local lists of approved products [2].

References

1.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. July 2006.

2.  Pharmaceutical pricing and reimbursement information Poland. October 2007.

3.  International Society for Pharmacoeconomics and Outcomes Research. Global health care systems road map. Poland - reimbursement process [ homepage on the Internet] New York, USA, ISPOR c2011 [cited 2013 Nov 18]. Available from: www.ispor.org/htaroadmaps/Poland.asp

4.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Access to Essential Medicines in Poland. August 2009.

5.  European Commission. Competition DG. Pharmaceutical sector inquiry preliminary report (DG Competition Staff Working Paper). 20 November 2008. Available from: ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf

6.  European Federation of Pharmaceutical Industries and Associations. Patients W.A.I.T. Indicator phase 8 report. Prepared for EFPIA by IMS Management Consulting. November 2007.

Useful information sources
EMA, Committee for Medicinal Products for Human Use (CHMP). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) [homepage on the Internet]. 20 January 2010 [cited 2013 Nov 18]. Available from: www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

European Medicine Agency, Committee for Medicinal Products for Human Use, EMA procedural advice for users of the centralised procedure for generics/hybrid applications (EMEA/CHMP/ 225411/2006) [homepage on the Internet]. London, UK. 2 July 2008 [cited 2013 Nov 18]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf

European Medicine Agency, Committee for Proprietary Medicinal Products (CPMP), Note for guidance on modified release oral and trans-dermal dosage forms: Section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96) [homepage on the Internet].  London, UK. 1999 [cited 2013 Nov 18]. Available from: www.ema.europa.eu/pdfs/human/ewp/028096en.pdf

European Medicine Agency, Committee for Proprietary Medicinal Products (CPMP), Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [homepage on the Internet].  London, UK. 1995 [cited 2013 Nov 18]. Available from: www.ema.europa.eu/pdfs/human/ewp/023995en.pdf

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