WBJ: Some say that new regulations in pharmaceutical law are long overdue. How does the Polish Association of Pharma Industry Employers (PZPPF) view the current legal conditions related to operations?
Barbara Misiewicz-Jagielak: We are in a situation where the most interesting legal provisions – including those promised earlier – are yet to be implemented. In 2016, the then Minister of Economy, Mateusz Morawiecki, who was trying to boost economic development, noticed the innovative pharmaceutical sector in Poland and its high potential for investment. We have, after all, many companies with Polish capital, and several large foreign companies that have settled here. Considering the fact that an enormous amount of funding goes towards the reimbursement of drugs, it is worth spending that money in a way so as to stimulate the Polish economy. Discussions have been ongoing for four years, and some promises were made that encouraged the drug manufacturers to start investing. However, the project called the Refund Development Mode (RTR) still hasn’t been implemented.

How exactly would the RTR work?
Our sector is very highly regulated. The Minister of Health decides on the prices for reimbursed drugs, which make up about half of our portfolio. The problem is that the health ministry sets goals that are sometimes at odds with the interests of the Polish economy. Sometimes those conflicting interests cannot be reconciled because while importing medicines from China would probably be the cheapest option, Prime Minister Mateusz Morawiecki insists on supporting our own providers to boost the national economy. Jadwiga Emilewicz, Minister of Entrepreneurship and Technology, proposed setting price conditions based on companies’ suitability. For now, however, the Ministry of Health does not seem particularly interested in such a proposal.

As a new government has now been formed, can this problem be solved?
Deputy Minister of Health Janusz Cieszyński has indeed promised to deal with this project at the beginning of the government’s new term. Both he and the prime minister care about the development of our sector.

How about other provisions that deal more generally with business matters? How favorable are they?
Economic departments are actually trying to create a friendly ecosystem for our industry. There are also many European regulations created on the basis of the EU law which have a big impact on the activities of this sector. That said, there are still some inconsistencies and differences in how particular ministries interpret the law. Most certainly, there is no government strategy for the pharmaceutical industry. This is a situation that does not occur in much wealthier countries.

How important is cooperation with foreign entities?
First of all, it should be remembered that no producer in the pharmaceutical sector is self-sufficient. Drugs are made from active substances obtained from intermediates, and there are no factories of this type in Poland, except the one in Starogard Gdański. Today, the vast majority of ingredients are imported from Asia, mainly from China, and several European countries. Of course, cooperation between entities is not only about importing drug ingredients. Perhaps we lost a great opportunity in 2017 when the RTR was meant to enter into force. Foreign companies were looking to cooperate with Polish companies and intended to become partners for the Polish economy. However, since RTR was not successful, neither were the deal negotiations. Cooperation is absolutely vital. It also concerns biotechnology companies, because they are not self-sufficient. However, it works both ways, because some Polish firms have offices and factories outside of Poland.

And what about the availability of medicines today? Is the country’s pharmaceutical safety currently guaranteed?
For many years, globalization seemed to be the solution to all problems. Then China released much cheaper, good-quality active substances, which caused most European manufacturers to go bankrupt. However, two years ago an environmental law was introduced in China, and costly investments in environmental protection affected the price of active substances. As a result, prices went up, and the production volumes went down. It also had an impact in Poland – we depended not only on those supplies but also on the conditions of the import of medicines. We must be prepared for similar situations.
The recent drug crisis, which resulted in a shortage of medications in our pharmacies, only confirmed our dependence on imports. We need to remember that the Polish market is only a priority for companies that produce drugs here. When there are problems in accessing certain medicines, Germany will first protect the German market, France will focus on their own companies, etc. Therefore, we must become independent from foreign drug supplies and increase the production of pharmaceuticals in Poland. Only then will we be able to talk about the stability of the Polish drug market, and therefore the safety of Poles.

Are other costs such as clinical trials a heavy burden?
Clinical trials mainly concern drugs that are not already available. Domestic producers concentrate on the production of generic medicines, and fortunately, the associated costs are not so high. But the outlay on research and development of the pharmaceutical industry is much higher than in other sectors of the Polish economy. Between 2016 and 2018, every other company from this sector (52 percent) carried out research or introduced innovative products to the market. This is almost twice the percentage of the average rate for the entire industrial production in Poland (26 percent). The pharmaceutical industry spends about PLN 700 million a year on innovation, which is about 60 percent of its profits. This places the industry at the top of Poland’s innovative sectors.

Does this mean that we can expect many innovative drugs to be introduced in the near future?
It doesn’t work that way. A breakthrough drug that changes therapy comes along every ten years. Most new drugs are, unfortunately, only slightly better than those already available on the market. Domestic companies mainly focus on the development of generic medicines used by millions of patients. Therefore, our research is going to improve the form of these drugs so that patients can take them without worrying about side effects. Domestic companies specialize in drugs that are difficult to manufacture and those that have added value. The latter include medicines that combine two or three active substances in a single pill. It is a real game-changer for patients because they only have to take one pill instead of three. Without a doubt, this is a huge technological challenge. Imagine two or three substances that are released in different sections of the gastrointestinal tract, at different times, often affecting each other, encapsulated in an easy-to-swallow tablet. The technology of drug forms changes very quickly, and our scientists are eager to take advantage of the new solutions.

What other trends are currently making waves in the industry?
In addition to the above-mentioned combination drugs, the most popular are those with prolonged effects and the equivalent biological drugs. More and more emphasis is also put on healthier products without preservatives, such as eye drops. The industry also invests a lot of money in environmental protection.

And what does the competition look like on the market?
Medicine patents last 20 years, so their producers are de facto monopolists. After a patent expires, the drug can be manufactured by other companies, and then the competition begins. Domestic companies are doing better and better in this field. We also noticed that our society is becoming more mature and more aware when making choices. Poles may have been delighted with everything that was foreign, but economic patriotism is our innate quality. That is why we choose products made in Poland more and more consciously. It has got to the point that when a foreign pharmaceutical company enters Poland, their products are sold under Polish names because Polish patients prefer drugs manufactured in the country.

Barbara Misiewicz-Jagielak
Vice President of the Polish Association of Pharmaceutical Industry Employers Director of Price Strategy and Refunds at Polpharma