– Poles trust the drugs produced in the country and want to be treated with them. Almost half of them, if they have a choice of cheaper medicines imported from Asia, will choose a slightly more expensive domestic one – says Krzysztof Kopeć. According to the president of PZPPF, only the government’s support for the domestic pharmaceutical industry can help in dealing with the drug crisis.
- In recent years, the cost of producing drugs has increased. On the other hand, there is excessive pressure to reduce domestic drug prices. The government needs to implement new solutions
- The solutions included in the Developmental Reimbursement Mode will translate into greater drug sovereignty in Poland, and thus greater patient safety
- Poles trust the drugs produced in the country and want to be treated with them – the opinion poll shows that almost half of the respondents, if they have a choice of cheaper medicines imported from Asia, will choose a slightly more expensive domestic one.
In October, the Central Statistical Office published a report which shows that the pharmaceutical industry is in the lead in terms of innovation in the Polish economy. Every second Polish drug manufacturer introduces innovative products to the market. Meanwhile, our country is plunged into a drug crisis. What does this mean in practice? Why in Poland should the production of pharmaceuticals be supported and how can it be done? In an interview with Medonet, explains Krzysztof Kopeć, President of the Management Board of the Polish Association of Pharmaceutical Industry Employers.
Aleksandra Lipiec, MedTvoi Locations: Which achievements of the Polish pharmaceutical industry can be considered the greatest?
Krzysztof Kopeć, president of PZPPF: Domestic companies conduct research on improving the currently available medicinal products. They are examined by, among others in terms of increasing the safety and efficiency of use or reducing side effects. They try to increase the patient’s access to modern therapies and make it easier for patients to comply with the doctor’s instructions. They introduce modern drug formulations, e.g. with the use of ingredients that accelerate the dissolution of the drug substance or mask the unpleasant taste. They are developing new forms of administration, such as chewable tablets, buccal tablets, transdermal tablets, sustained release tablets and “combo” products that are a combination of medicinal substances.
In addition, they are working on the mechanisms of the controlled release of the active substance, which will allow for long-term action of the drug with a reduced frequency of taking subsequent doses. They are also looking for new indications for existing drugs. What’s more, Companies operating in Poland implement improved production processes, their own, patented methods of synthesis, often safer for the environment.
Our country is also affected by the dynamic development of the biological medicines sector, which has opened up new perspectives for medicine. Domestic companies introduce to the market biological drugs that compete with those already present on the market.
In what direction will the pharmaceutical industry in Poland go in the coming years?
In recent years, there has been significant increase in drug production costs. If we add to this excessive pressure to reduce the prices of domestic drugs, which results in a decline in the profitability of the production of pharmaceutical products, we can expect problems in our country. Unless the government implements some tools to support the production of drugs in Poland, which will guarantee Poles safety in access to pharmacotherapy.
Many biological drugs expire causes that many companies start their production. In order to register their drugs, they must demonstrate, on the basis of clinical trials, that they work in the same way as the drugs already on the market. If studies show their equal value in relation to a drug already available on the market, the European Medicines Agency approves them for treatment. Different names are used for these new drugs: biosimilars or, more precisely, biological equivalent drugs. Their appearance on the market stimulates competition and lowers prices by up to half. This makes it possible to treat a much larger group of patients. The development of the production of these drugs in Poland is not only an opportunity for the development of the pharmaceutical industry, but also improving access to biological therapies in Poland.
How is drug production in other countries supported? Can the same solutions be introduced with us?
Such support is not always reflected in the regulations. But a German or a French official, if he has the choice of reimbursement of domestic and imported drugs without administrative regulations, chooses the native one. This is not always how it works in Poland. That is why we strive for statutory provisions.
Spain has a long, 30-year-long, tradition in supporting the local pharmaceutical industry. In 1986, the Farma program was launched, the latest edition of which for 2017–2020 is aimed at increasing employment in the pharmaceutical industry, increasing investment in development, production and exports. Since the launch of such a program in Spain, the amount of expenditure on research and development of pharmaceutical companies operating on that market has doubled, and the dynamics of the increase in drug exports has reached the EU average.
Does the production of drugs in Poland have a chance to support the Development Reimbursement Mode (RTR)?
According to the IQVIA pharmaceutical market research company in the EU, the development of the domestic pharmaceutical industry can be effectively supported. All those who decided to do so benefited not only economically through the country’s economic growth, but also increased the level of drug safety, becoming independent from external supplies. The solutions included in the Development Reimbursement Mode, i.e. preferences for companies producing drugs in Poland when negotiating the prices of reimbursed products, will translate into an improvement in the foreign trade balance, increased production capacity and investments in the country. This will ensure Poland greater drug sovereignty, and thus patient safety.
In July, the Ministry of Entrepreneurship and Technology published a report on the recommendation to implement the Development Reimbursement Mode (RTR) into the Polish law. According to the recommendations, reimbursement preferences are to be granted to companies with the status of a Partner of the Polish Economy (PPG). The project aims to support enterprises that contribute to the development of the pharmaceutical industry in Poland. All companies operating on the market, regardless of their size or capital, will be able to obtain PPG status. The Ministry of Entrepreneurship and Technology hopes that thanks to this, drugs developed in Poland will start gaining reimbursement support.
Will the development of the domestic pharmaceutical industry be a recipe for drug shortages in pharmacies?
Due to the shortage of drugs across Europe, both EU and Member State authorities are wondering what to do to bring pharmaceutical production back from Asia to Europe. However, we must remember that in the event of a smaller supply of drugs on the market, each country will first take care of its own citizens. European solidarity will not help then. The German drug factories will first supply pharmacies in Germany, and the French ones will take care of the market in France. In addition, due to the fact that Poland has one of the lowest drug prices in the EU, it is not a priority market for anyone. Therefore, drug safety can only be guaranteed by the production of drugs in Poland, because our market is a priority for domestic companies.
Poles prefer to buy drugs from Polish producers?
A public opinion poll commissioned by PZPPF in April this year showed that Poles trust the drugs produced in the country and want to be treated with them. Almost half, if they have a choice of cheaper medicines imported from Asia, will choose a slightly more expensive domestic one, and another 28%. – if it is at a comparable price. 2/3 of the respondents believe that the production of drugs in Poland is a guarantee that there will be no shortage of them in pharmacies. 64 percent claims that it would feel safer if most of the drugs available in pharmacies were manufactured in Poland. Poles are largely conscious consumers who make responsible choices. They buy with the conviction that good quality is behind local production. It is equally important that thanks to such purchases they have an impact on the Polish economy and the labor market.
How big is the share of Polish drugs in the domestic market at the moment?
Domestic drug manufacturers supply every second drug sold in Polish pharmacies. When it comes to reimbursed products, these domestic producers account for about 40 percent. However, their share in the market value is only 20%. Meanwhile, more and more Asian companies are selling drugs in Poland.
What is the Polish economy gaining now, and what may it gain in the future thanks to support for the domestic pharmaceutical industry?
The pharmaceutical sector remains one of the most developing industries. It is an important element of the economies of technologically advanced countries. In the case of small countries, it can even be the foundation of development. This is due to the growing demand for drugs due to the aging of Europe, the industry’s resilience to economic crises and a strong commitment to research and development. The industry provides above-average wages and generates over 100 jobs. jobs. As a highly specialized branch of industry, it can provide an impulse for the development of innovation also in other industries, e.g. agri-food or chemical production.
In Poland production of pharmaceutical products generates approximately PLN 4,35 billion of budget revenues in the form of taxes and social security contributions (2015). The state’s financial resources would be reduced by this value if pharmaceutical products were exclusively imported. The NHF’s expenditure on the reimbursement of drugs produced by this sector amounted to less than PLN 2,5 billion, which from the perspective of the state budget means a profit (positive net effect) of PLN 1,8 billion.
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