Generic drugs in Poland

What are generic drugs?

Patent protection for a newly introduced drug on the market lasts almost 20 years. During this time, no other company (except the one with the patent) has the right to produce it. When protection ends, the drug may be manufactured by other manufacturers who begin to compete with each other – such competing drugs are called generics.

The original and generic medicine may differ in name, manufacturer and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount will always be the same. Thanks to the guarantee of equally high production standards and constant monitoring of safety and effectiveness, patients can freely choose the product that best suits them in the pharmacy. The manufacturing process of generic drugs must follow the principles of Good Manufacturing Practice (GMP). Compliance with the GMP rules allows for the provision of good quality medical devices.

When can a drug be called “generic”?

We can talk about a drug that is an equivalent of an original drug, also known as a generic drug, when it meets several conditions:

  • the same composition (quantitative and qualitative) of active substances as the original (reference) medicinal product,
  • the same form (tablets, syrup, inhaler, etc.),
  • it has been proven that its operation is consistent with the reference medicinal product (bioequivalence and bioavailability studies).

As with all drugs, generic drugs must pass appropriate evaluation processes in order to obtain a marketing authorization, and ensure their quality, safety and efficacy. Authorized generic medicines are regulated in the same way as the originator medicines. For this reason, the patient – despite the fact that the doctor has prescribed a specific drug – has the right to replace it with another.

How do generic drugs differ from innovative drugs?

A different composition of excipients is possible. Their selection in the case of generic drugs may, however, have a positive impact on the therapeutic process. When introducing an equivalent of the original drug to the market, manufacturers very often use more modern production lines or implement innovative solutions. They can eliminate unpleasant taste, reduce the size of the tablet, which is of great importance, e.g. in the case of drugs used in children.

However, it is important to know that the use of other fillers may also, in some cases, modify the action of a generic drug, such as its dissolution or absorption. As a result, this may lead to a change in the effectiveness of the drug and the occurrence of side effects.

The shape, color and size of a generic drug may differ from the original drug – these features do not have any properties affecting the therapeutic effect.

Why are generic drugs cheaper than innovative drugs?

It is estimated that the cost of purchasing the cheapest generics does not exceed 10% of the original price of the original drug. The lower price of generic drugs depends on many factors, including the fact that the companies producing these drugs do not have to carry out as many preclinical and clinical trials on animals and humans as innovative companies, which does not require such a large financial outlay.

After all, the length of the research conducted also contributes to the reduction of costs related to the production of drugs. The average time of work on an innovative drug is approx. 10–12 years. Of the thousands of pre-selected chemicals, many are eliminated at different stages of the research process. Hundreds of substances are tested in preclinical studies, and then over a dozen of them in a clinical trial. Ultimately, at most a few, and sometimes only one, originally selected compounds enter the pharmacy market. The development time for a generic drug is much shorter and ranges from 2 to 5 years. So the savings for generics are much higher.

Moreover, the marketing of a generic drug is simpler than the registration of an innovative drug, as the applicant may rely on the clinical and preclinical studies of the prototype. It is obliged to provide evidence that it meets the quality, effectiveness and safety requirements in the form of qualitative, preclinical and clinical tests. The registration process of a generic drug itself takes from 1 to 2 years, sometimes it may be extended.

Market of generic drugs in Poland:

Analysts say that the generic drugs market in 2008 was worth EUR 17.2 billion, and predict its further development. Also in Poland, generic companies have a large share in the pharmaceutical sector. Among many European countries, it is Poland that is the leader in terms of value and quantity of generic drugs sold. In terms of value, generic drugs constitute 88% of the drug market in our country, and in quantitative terms – approx. 66%, which is definitely more than in other countries.

The problem with obligatory reductions in the prices of generic drugs in Poland

Generic drugs are inherently much cheaper than innovative drugs. In Poland, however, according to the report of the Polish Association of Pharmaceutical Industry Employers, the average price of one tablet of a generic drug sold in hospital and pharmacy channels is one of the cheapest compared to 19 EU countries.

The average cost of one tablet of a generic drug in Poland is 10 cents. It is still so cheap in the Netherlands and Romania. In other EU countries, one generic tablet is more expensive.

In Poland, according to the applicable reimbursement act, the first generic drug to enter the reimbursement list must be 25 percent cheaper than a drug that has expired. If more generics appear on the market, the price drops even more. Despite the fact that this is the case – the Ministry of Health, during the negotiations, forces producers to reduce the prices of the same products every three years – as a result, Poland has reached the lowest level in the EU.

Further price reductions will inhibit the development of the domestic industry for which the Polish market is a priority. A significant drop in the profitability of the production of pharmaceutical products in Poland results in a reduction in investment outlays.

How does lowering the price of generics hurt patients?

The large difference in prices between Poland and other EU countries is conducive to the illegal export of drugs abroad. It also threatens to give up sales on the Polish market, because lowering prices in one country generates similar price expectations in other markets. As a result, Polish patients may be left without therapy. In countries where bidding systems have been introduced or where compulsory reductions have been applied, there have been major problems with the availability of drugs to patients.

The introduction of significant, obligatory price reductions without negotiation led to a lack of 1,400 drugs in Hungary, 700 in the Netherlands, and 315 in Lithuania. On the other hand, there is no shortage of drugs in countries where there is competition and many suppliers.

KIELTYKA GLADKOWSKI KG LEGAL assists Clients in overall legal procedures related to market authorization, pricing, regulatory permits and advertising.