All questions
Overview
As an EU Member State, Poland has generally aligned its regulations in the pharmaceutical sector and competition law with the measures applicable in the European Union. Although generic and food supplement manufacturers maintain undisputed quantitative superiority in the pharmaceutical market in Poland, a few Polish companies with significant innovation capacity, also operating on foreign markets, have grown. Some tensions between manufacturers of generic and innovative medicines can be observed primarily in connection with reimbursement processes and in the area of patent law claims.
Poland is a party to the Agreement on Trade-Related Aspects of Intellectual Property Rights and the European Patent Convention (EPC), which ensures that the crucial Polish patent law measures are compliant with the EPC. As a result of the recent amendment to patent law in Poland, a significant extension of the scope of the patented invention exploitation under the Bolar exemption has been introduced, which will allow generic manufacturers to speed up their market entry.
Poland has introduced in its regulations on the marketing of medicinal products separate measures pertaining to pharmacies regarding operating authorisations and the permitted advertising of pharmacies. Regarding the Polish market, there have been few competition law cases related to the pharmaceutical industry.
This chapter describes the practical aspects of the registration of medicines, their marketing and the specific character of patent protection, with special reference to the competitiveness aspects of innovative and generic medicines.
Legislative and regulatory framework
i The main legislation providing for authorisation
The provisions on granting marketing authorisations for medicinal products are laid down in the Act on Pharmaceutical Law (the Pharmaceutical Law), adopted in 2001 and subsequently amended in a number of ways.2 This law is almost entirely based on Community law and implements all EU directives on medicinal products for human and veterinary use. Naturally, numerous Community regulations governing medicinal products are directly applicable.
National marketing authorisations for the medicinal products market are granted by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, while the marketing of medicinal products is subject to the Office of the Chief Pharmaceutical Inspector.
ii Pricing policy
The pricing policy for medicinal products is one of the most sensitive issues. Drugs and foodstuffs intended for particular nutritional purposes and reimbursement policies for medical devices are governed by the Act of 12 May 2011 (the Reimbursement Act).3 The impact of Council Directive 89/105/EEC on the reimbursement policy and measures regulating the pricing of medicinal products is evident, as it was transposed in its entirety by the Reimbursement Act.
The drug reimbursement decision-making process is undertaken by the Minister of Health and is subject to judicial review. A reimbursement decision should be taken within 180 days of the date of the submission of a completed application form.
Prior to the decision, the Minister of Health conducts negotiations with pharmaceutical companies in compliance with the principle of transparency. The criteria that inform the Minister’s reimbursement decisions are specified in the Reimbursement Act.
In exceptional circumstances, the Reimbursement Act provides for the reimbursement of medicines obtained by importation as well as for off-label indications.
To ensure their social adequacy, reimbursement notices are issued on a bimonthly basis. Thus far, the total reimbursement budget has not exceeded 17 per cent of the total public funding allocated to financing guaranteed benefits. Theoretically, the prices of generic medicines should be lower than the prices of innovative medicines; however, the differences are not always significant.
iii Public purchasing of pharmaceuticals
Either retail or wholesale marketing is available for medicinal products, and authorisation by the competent pharmaceutical inspection authority is required on a case-by-case basis.
In the context of the operation of pharmacies in Poland, the key issues that are still widely discussed are:
- the recently imposed demographic restrictions (the number of inhabitants in a municipality per pharmacy);
- geographic restrictions (the minimum distance between pharmacies); and
- subjective restrictions (the permit to operate a pharmacy is granted only to a pharmacist, a registered partnership or a professional partnership whose sole core activity is the operation of pharmacies and in which the partners are only pharmacists).
The absolute prohibition of advertising pharmacies is also debatable.
In accordance with Article 94a of the Pharmaceutical Law, advertising pharmacies and their activity is forbidden. Only information about the location and the opening hours of a pharmacy does not constitute an advertisement.
The prohibition of advertising pharmacies is interpreted very strictly by the regulatory authorities, which has resulted in numerous penalties being imposed on pharmacies and has been the subject of administrative court judgments. Most legal scholars and commentators consider the absolute prohibition of advertising pharmacies to be an excessive restriction of the freedom to conduct business. It has been the subject of a notification submitted to the European Commission regarding the incompatibility of the Polish measures with EU law.
As far as wholesale marketing is concerned, the direct sale of medicinal products to a pharmacy has become the main unresolved issue. In such a model of distribution, the medicinal product remains the property of the manufacturer until it is purchased by the user, while the wholesaler is only an intermediary.
Having been extensively discussed, this model was eventually approved as it prevents excessive drug export, which may sometimes prove profitable owing to price differences within individual EU countries. Such export naturally conflicts with the interests of innovative drugs manufacturers, as it prevents them from taking advantage of the possibility of market-sharing in terms of prices.
However, selling medicines by pharmacies to wholesalers who then resell them abroad (the reverse drug distribution chain) has been found unlawful as pharmacies are authorised to sell medicines exclusively to the end user.
The sale of medicinal products via mail order is permitted only with respect to over-the-counter products.
iv Specific measures for innovative products
As in other European countries, Poland has introduced measures to promote bringing innovative medicines into the market. These measures include regulations providing for data exclusivity and market exclusivity, which have been entirely based on EU directives.
Marketing authorisations for generic medicinal products for human use based on a reference medicinal product that is or has been authorised in Poland or a Member State of the European Union or the European Economic Area (EEA) and may be granted if a period of eight years has elapsed between the date of granting the first marketing authorisation for a reference product in any of those countries and the date of applying for a marketing authorisation in Poland. If an indication constituting a significant clinical benefit is added, this period may be extended by a further 12 months.
After eight years, an application for a marketing authorisation for a product can be submitted; however, only 10 years after granting the first marketing authorisation may the product be placed on the market (market exclusivity). Data exclusivity protection is currently independent of patent protection.
v Liability for infringement of data protection and market exclusivity provisions
If a marketing authorisation has been granted for a medicinal product that is a generic version of the reference product within the period of exclusive data use, with reference to the data in question, and without the consent of the holder of the right to exclusive data use, or within the period of the reference product market exclusivity, the State Treasury incurs liability for the damage caused by granting such an authorisation under the provisions of the Civil Code.
Any party with a legitimate interest can have access to the register of medicinal products and the documents submitted in the proceedings on market authorisations; however, the provisions on the protection of classified information and industrial property must be respected.4
Regarding the applicant’s liability for unjustified reference to the reference product within the period of data exclusivity, this liability can be derived from the protection of business secrets provided for in Article 11 of the Act on Combating Unfair Competition.5
vi Supplementary protection certificate
Both the essential conditions for granting a supplementary protection certificate (SPC) and the scope of its protection have been laid down in Regulation (EC) No. 469/2009, which is directly applicable in Poland. The procedural issues for granting an SPC are regulated in the Act on Industrial Property Law of 30 June 2000, as subsequently amended (the Industrial Property Law).6
There have been a few disputes concerning the interpretation of the criteria for granting an SPC. The interpretation of the Polish Patent Office (PPO) has been in accordance with the narrow construction of the notion of ‘product’ as judicated by the Court of Justice of the European Union (CJEU) in Santen.7