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Policies and Legislation Posted 26/11/2013

First posted: 26 November 2013 

Poland does not have a coherent generic medicines policy however there is generic medicines competition within the existing regulatory frameworks [1].

Although Poland does not have a clear generic medicines policy in place, there is a strong tradition of generic medicine usage in the country, and the principal stakeholders—such as physicians, pharmacists and patients—are clearly favourable to generic medicines [1].

Difficult economic conditions and limited government funds have increased patient co-payments resulting in patients requesting the cheapest (generic) medicines for treating a given condition or illness. A history of local production has also played a role in greater market shares in the region [1].

There are neither specific rewards for pharmacists for dispensing generics nor specific incentives for physicians to prescribe generic medicines. Both physician and patient may oppose generics substitution [2].

Intellectual property
As in many Central and Eastern European countries, prescription of generic medicines is common practice due to the limited availability of originator medicines in ambulatory care prior to the end of communism in 1989 and due to the absence of product patents until the early 1990s [3].

The Polish generic medicines market benefited from regulation imposing a three-year data exclusivity period until EU accession of Poland. During the data exclusivity period, the application for marketing authorisation for a generic medicine cannot refer to the preclinical and clinical documentation of the originator medicine. As the Polish data exclusivity period was shorter than the 6–10 years of data exclusivity granted in the EU at that time, this served to speed up entry of generic medicines into the Polish market [3].

In recent years, there has been a significant increase in the market share of imported originator medicines. Furthermore, the introduction of supplementary protection certificates for all patented medicines registered in Poland since 2000 is expected to reduce generic medicines market shares in future years [3].

Pricing
Polish medicine prices tend to be lower than those in other EU countries. Poland operates a price-regulated system for medicines that wish to be entered on the reimbursement list [3].

Generic medicines are normally reimbursed when a positive reimbursement decision is made. However, the product itself does not need to be listed with its specific brand name to be reimbursed if the relevant original is listed and the generic drug comes in the same pharmaceutical presentation and does not exceed the reimbursement limit price. In such a situation, generics substitution in pharmacies is allowed and the product will be reimbursed by the national health fund [4].

Reference pricing
There has been a reference pricing system (RPS) in place in Poland since 1998 [4].

Poland runs two RPSs in parallel, one by active ingredient, International non-proprietary name (INN) and the other by therapeutic group [2]. The RP is set below or equal to the price of the cheapest generic medicine [3].

Generics must show a minimum 25% price decrease on the original product’s price when entering the reimbursement list. The next generics must then decrease their price by a further 25% and any generics introduced into the list after that cannot be any more expensive than the cheapest generic drug in the therapeutic group, i.e. the RP [4].

In spring 2005, there were 221 RP groups of pharmaceuticals with the same active ingredient and 23 RP therapeutic groups [2].

Since March 2009, for the first time, parallel imported medicines were included in the reimbursement list [5].

Pharmacists are allowed to substitute within one INN group, whereas therapeutic substitution is not allowed [2].

Physicians are allowed to prescribe medicines priced above the set reimbursement limit, but patients must then co-pay the difference [4].

International price comparison
Medicine prices in Poland are set according to the lowest prices in the following countries: Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, The Netherlands, Portugal, Spain, Sweden, Switzerland, and UK, for identical or comparable products [4].

Incentives for physicians
In Poland, there are no prescribing budgets or financial incentives for physicians or budgetary sanctions in case of non-adherence [2, 5].

Prescribing of branded and non-branded generic medicines is common because physicians have long-term, positive experience with generic medicines and because they are conscious of the limited ability of patients to meet co-payments [3].

Physicians are allowed to prescribe by INN, but are not obliged or encouraged to do so. They are also not assisted in generic drug prescribing and the prescribing habits of physicians are not monitored [2, 3].

Physicians are not obliged to inform patients about generics substitution or co-payments [2].

Incentives for pharmacists
Generics substitution by pharmacists is allowed, but not obligatory [6]. However, only the same molecule can be substituted; changing the molecule, even for one of the same therapeutic group, is prohibited [4].

Pharmacists are obliged to inform patients of the availability of cheaper generic medicines and of generics substitution [2, 3].

In the case of the prescription of a branded generic medicine, the pharmacist can dispense any generic medicine. If the physician prescribes by INN, the pharmacist may deliver any originator or generic medicine [3].

Generics substitution by pharmacists is conditional on physicians not forbidding substitution, i.e. if the physician does not indicate otherwise on the prescription, i.e. NZ (Nie zamieniac), meaning ‘Do not substitute’ [4].

Until the mid-1990s, pharmacists earned a margin of 33% on local medicines and 25% on imported medicines irrespective of whether this concerned originator or generic medicines [3].

Since 1995, Poland has adopted a sliding scale where the percentage remuneration decreases as the price of the medicine rises. However, the regressive effect of this scale is not sufficient to remove the financial incentive to dispense originator medicines [6].

Discounts awarded by pharmaceutical companies encourage pharmacists to dispense generic medicines [3].

Incentives for patients
Patient co-payments in Poland are high. Patient co-payments for reimbursed medicines on average reach 33.4% [4]. This is equal to 63% of total medicines expenditure in Poland [4], which is very high compared with the EU average of 36% [5]. A survey by GfK Polonia showed that a significant number of Poles do not buy the necessary medicines for financial reasons [7].

Four rates of patient co-payment apply depending on the therapeutic class and patient characteristics [3]. Patient co-payment in Poland can be up to 50%. The WHO considers co-payment above 25% to be a barrier to access to medicines [8].

Patient co-payment consists of 100% reimbursement for medicines for diseases such as epilepsy, oncology and diabetes [5]. Essential medicines incur a fixed amount per prescription. Supplementary medicines are subject to a patient co-payment of 30% or 50%. Other prescription medicines that are not included in the reimbursement lists as well as over-the-counter medicines are fully paid for by the patient [3].

Medicines at 50% reimbursement are usually those very commonly used in not particularly serious diseases, e.g. hypertension, hyperlipidaemia or menopause. Medicines reimbursed at 70% are usually those in the category of not life-threatening but chronic diseases such as Parkinson’s disease or Alzheimer’s disease—for these, patients have to co-pay 30% of the reimbursement limit plus the amount (if any) that is over that limit. The full reimbursement, with a Zloty 3.20 (Euros 0.77) lump sum to be paid with every medicine pack in a prescription—maximum of two medicaments per prescription, usually the number of packs equal to monthly therapy for each, is usually applicable to antibiotics, ophthalmic medicines or other commonly used medicines [4].

For medicines dispensed to inpatients during their stay in hospitals, no co-payments are applied [5].

In Poland, there are no lower reimbursement rates for generics. However, through the introduction of the RPS, there has been a consistent policy of promoting generics alternatives [5].

Patients can ask the physician to prescribe a cheaper product of the same therapeutic group or a cheaper generic drug product [4].

Since the official wholesale and retail prices of medicines represent maximum levels, prices may differ between pharmacies. So patients can ‘shop around’ for the cheapest medicine. However, there are plans to change from maximum to fixed retail prices in the near future [2].

Although it is not allowed, patients are informed about other available medicines in pharmacies, i.e. generics substitution. Also, information on price decreases in pharmacies is distributed in leaflets or via newspaper adverts, or is advertised in pharmacy windows [4].

Since 2006, (maximum) prices for reimbursable medicines, as well as information on co-payment, can be accessed via the Internet on the database on the website of the Ministry of Health. The website also provides information on the cheapest medicine with the same active ingredient, based on the cost for defined daily doses [2].

Patients can ask for substitution by a generic drug and can also oppose it, but must then pay the difference between the reference price and the pharmacy retail price [2].

Pharmacists are obliged to inform patients about the opportunity of buying a cheaper medicine than that prescribed, unless the prescribing physician excluded any such substitution. Physicians are not obliged to inform patients about co-payment [2].

There have been no initiatives to inform patients about generic medicines undertaken in Poland [3, 4].

Policy analysis

Key factors aiding the development of the generic medicines market

  • The economic viability of the generic medicines market originates from low prices and high volume of consumption [3].
  • Setting the RP at the level of the cheapest generic medicine has led to low prices of generic medicines [3].
  • Physicians in Poland have a favourable attitude of towards generic medicines [3].
  • Generics substitution by pharmacists is allowed [2, 4].
  • Discounts awarded by pharmaceutical companies encourage pharmacists to dispense generic medicines [3].
  • Pharmacists are obliged to inform patients of the possibility of receiving cheaper (generic) drugs [4].
  • Patient co-payments are high, driving demand for lower-priced generic medicines [3].

Key factors hindering the development of the generic medicines market

  • Medical students are not taught to prescribe by INN at medical school.
  • Physicians are allowed to prescribe as they see fit—by generic drug name, brand name or INN [4].
  • Physicians have no incentives, financial or otherwise, to prescribe generics [3, 4].
  • Pharmacists are financially penalised for dispensing generics [3].
  • No information activities have been organised for patients [3].

References

1.  Bongers F, Carradinha H. European Generic medicines Association Health Economics Committee. How to Increase Patient Access to Generic Medicines in European Healthcare Systems. June 2009.

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

3.  Simoens S, De Coster S. Sustaining Generic Medicines Markets in Europe [homepage on the Internet]. Brussels, Belgium. European Generic medicines Association. 2006 Apr [cited 2013 Nov 26]. Available from: www.egagenerics.com/doc/simoens-report_2006-04.pdf

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

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

6.  Simoens S. Developing competitive and sustainable Polish generic medicines market. Croat Med J. 2009;50(5):440-8.

7.  Polski Związek Pracodowców Przemysłu Farmaceutycznego. [News: The delay means loss. Loss for the National Health Fund and patients due to delay in the introduction of generic drugs on the reimbursement list]. Aktualności: Opóźnienie znaczy strata. Straty NFZ i pacjentów z tytułu opóźnień wprowadzania leków generycznych na listy refundacyjne [homepage on the internet].2009 [cited 2013 Nov 26]. Polish. Available from: 212.85.101.126/news.php?id=47

8.  European Commission Competition DG. Pharmaceutical Sector Inquiry Preliminary Report. 28 November 2008.

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