Poland does not have such factories, but “we have factories of scientists and experts.” “A healthy patient – the economy is growing”

Katarzyna Pinkosz, “Wprost”: We are currently talking a lot about Poland's drug safety, which is no less important than military safety. What role can global pharmaceutical companies play in Poland's drug safety?

Michał Byliniak: The role of the innovative pharmaceutical industry in ensuring drug safety is fundamental and is determined not by the number of factories but by the place of API production and supply chains, which have performed exceptionally well despite strong pressure and high global demand for drugs during the Covid-19 pandemic.

The innovative industry has a completely different specificity than the generic one: we do not produce APIs in Asia, but mainly in Europe, thanks to which our medicines and active substances are not at risk of interruption of supply chains if, for example, China's borders are closed.

Why do we produce in Europe? This is so for various reasons, including: due to the protection of intellectual property, but also because we are a high-technology industry. The costs of producing this type of drugs in different parts of the world would not be so different. The availability of innovative drugs is very high.

So we are not at risk of running out of innovative medicines for patients, e.g. for cancer, diabetes or heart failure?

Ensuring access to medicines is a priority and it is not only the industry's responsibility, but also the obligations arising from the Reimbursement Act. One of the most difficult tests was the pandemic period; We passed this exam not only in Poland, but throughout Europe. Of course, there are always some risks, but they result from the specificity of individual products or short-term random events. Our industry has implemented very efficient and durable distribution chains so that patients can receive medicines.

However, the involvement of the innovative industry is much broader, and one of its expressions is the development of the Polish clinical trials market.

Poland ranks 11th in the world in terms of the number of clinical trials conducted, and the Polish market for commercial clinical trials is worth over USD 1.4 billion.

Thanks to this, many patients gain access to innovative life-saving therapies.

Tens of thousands of patients take part in clinical trials in Poland every year, and the number of trials conducted in Poland is systematically growing. In addition, clinical research centers are also being established that deal with clinical trials not only in Poland, but also in the region, and often also in large parts of the world. The centers also monitor side effects of drugs and provide IT and financial services.

Sometimes we say that we may not have drug factories in Poland, but we do have factories of scientists and experts. We train them not only for the Polish market, but also for the whole world.

What barriers do you expect to be eliminated to facilitate investments in Poland?

The most important thing for us is legal stability and predictability. In the long term, this is an element that determines how individual countries are assessed in terms of investment. Openness and a positive approach to innovation as an investment in the health of society, the effectiveness of the health care system and economic development are also important: all this is a condition for Poland to be perceived as an investment-friendly place. This is also important in the context of the debate currently taking place in the EU on the need to increase Europe's competitiveness in relation to the world.

Data from the Access GAP platform regarding the Visegrad Group show that access to innovative therapies in Poland is improving. This is also confirmed by experts. Is Poland today a country open to new drug technologies?

All indicators show that access to innovative medicines in Poland is improving, but the gaps are still large and it is necessary to at least maintain the growing trend. The government's approach seems to be key.

The changes that have occurred in the last few years have not involved changes in regulations; although these can of course make this process easier or more difficult. However, the approach of the Ministry of Health has certainly changed and we hope that it will not change.

So what changes do you expect?

The priority of standardizing access to the same services as in Europe is very important – because despite improvement, we are still below average, perhaps with the exception of oncology, where we are approaching the European average. The challenge is the growing incidence of oncological and lifestyle diseases. In both cases, the forecasts indicate an increase in the number of patients.

However, there are still challenges, such as diagnostics, which are necessary to provide patients with appropriate treatment at the right time. A positive reimbursement decision is very important, but it is not the only element that affects the availability of innovative treatment.

We very much appreciate the openness to the amendment of the Reimbursement Act, some of our comments that we have submitted seem to be reflected in it.

Innovative medicines are a chance for health for patients, but also have an impact on the economy when the patient recovers?

I compare a positive reimbursement decision to a stone that we throw into a lake; then larger and larger circles spread out, sometimes to places where they could not be expected. A positive decision means a wider range of therapies in the hands of doctors and nurses, it also gives an impulse for wider diagnostics and earlier detection of diseases, it also means new procedures in hospitals.

By providing free HPV vaccinations, we are able to significantly reduce the incidence of cervical cancer. Another example: patients with hepatitis C were previously treated with interferon and stayed at home because interferon caused serious side effects. Thanks to the availability of innovative treatment, today hepatitis C patients recover after 2-3 months, can work and function normally. The possibility of using innovative medicines directly and indirectly translates into the economy.

If the patient is healthy, the economy develops much better. Analyzes indicate that a one percent increase in the expected life expectancy of the population may translate into an increase in GDP by up to 6 percent.