Changes that Benefit Patients

That was the conclusion reached by participants in the debate “Reform of pharmaceutical law as a challenge for the Polish Presidency”, which took place in January in the editorial offices of Dziennik Gazeta Prawna.

According to Professor Marcin Czech, former Deputy Minister of Health for Drug Policy and President of the Polish Pharmacoeconomics Society, the European pharmaceutical package is the first major change of EU pharmaceutical market regulation in 20 years.

“From an economic point of view, it aims to make the European market more attractive in a geopolitical game, where the United States is in the lead and China, the rising star of healthcare innovation, is playing an increasing role. The most important objective of the package, however, is to harmonise access to innovative therapies across the Member States to ensure that all Europeans have an equal chance of receiving the most effective treatment available. This is what the incentive system is designed to do, encouraging pharmaceutical companies, including both innovative and generic drug producers, to come to the market quickly and efficiently. The pharmaceutical package includes regulation of health technology assessment, including regulation for joint clinical assessment, now coming into force. The package also covers the fight against antibiotic resistance and protection of the environment through sustainable resource use. These are complex and comprehensive changes aimed at increasing international competitiveness while providing better access to medicines for patients, including special patients, such as individuals suffering from rare diseases or the paediatric population”, said Professor Czech.

A task for the Polish Presidency

Enabling the broadest possible compromise on risk-sharing mechanisms to make innovative drugs as widely available as possible to patients, not only in the wealthiest but also in less affluent Member States, is a task for Poland, which assumed the six-month presidency of the European Union on 1 January. We asked MEP Adam Jarubas, Chairman of the new SANT Committee in the European Parliament, whether the negotiations will be finalised by the end of June.

“The Parliament has now completed its work. In April 2024, the Parliament’s negotiating mandate was voted in plenary after a long period of work and nerve-wrecking discussions with stakeholders. The task of the Polish Presidency is to develop a general approach, i.e. a Council mandate, to listen to all Member States, and to establish a common position. This will not be easy, which was already apparent during the December meeting between Health Minister Izabela Leszczyna and EU health ministers when positions were very diverse. We know that capital has a nationality, and pharmaceutical companies are asking their governments to look after their interests”, said MEP Jarubas.

He added that if work on the general approach goes well, there could be a chance to complete the work in the trilogues, or tripartite consultations where the final legislation is decided.

“However, this will require diplomatic skills and arrangements, which at this stage seem difficult to achieve due to divergent positions in the innovative and generic drug sectors. There is an unwritten rule that the presidency cannot officially lobby in its own interests, but Poland has a natural interest in ensuring that the balance between the innovative and generic drug sectors tilts in favour of the latter. This will require a balanced approach as the main bone of contention is data protection and market protection periods. The idea is to extend them when a drug manufacturer addresses new therapeutic indications or unmet medical needs”, said MEP Jarubas.

He quoted Professor Adam Maciejczyk of the Lower Silesian Oncology Centre, who says that the chances for successful treatment may depend on the genetic code, but should not depend on the postcode.

“Unfortunately, as the professor has said, some preparations in Poland become available a few years later than in Germany, for some drugs 2–3 years later. The idea behind the Parliament’s proposal is to establish a legal obligation for all manufacturers to apply for registration of a drug in each country”, added MEP Jarubas.

Needs in dynamic times

The perspective of pharmaceutical manufacturers was presented by Wojciech Wiśniewski, an expert from the Federation of Entrepreneurs and Employers and Deputy Co-Chair of the Tripartite Healthcare Committee.

“The Federation of Polish Entrepreneurs brings together mainly transnational companies, primarily owned by foreign capital, while expectations are defined in European-level discussions. The innovative drug industry has a vested interest in keeping the market protection periods as long as possible so that it can generate higher profits and reinvest them in creating new therapeutic options. On the other hand, it is in the interest of manufacturers of generic and biosimilar drugs to keep these periods as short as possible to commercialise their products. However, the debate on pharmaceutical law reform should not be considered in isolation for several reasons. US President-elect Donald Trump has suggested which way the US pharmaceutical industry will be heading, and it looks like tensions between the US and EU industries will escalate in the near future. Looking at the domestic market, the Polish government has for years been investing a lot of public money in the development of pharmaceutical companies. Many of them receive massive funding from the National Centre for Research and Development and the Medical Research Agency. With huge capital requirements, the idea is to create Poland’s first manufacturer of original drugs. With due respect for the position of the Polish Government and being aware of these interests, I hope that we can bring these ideas together and align our development policy with the final shape of legal reform at the European level. The interdepartmental challenge is how and how much we should invest in the development of the domestic industry”, said Wiśniewski.

He hopes that it will not take 20 years for the next round of pharmaceutical law revision, since we live in dynamic times that require more frequent reforms. He also stressed the need to recognise the potential of Polish companies in the clinical trials market (Poland is currently 13th in the world in clinical trials).

“Some Polish companies are transnational corporations with multi-billion dollar revenues. The clinical research sector in Poland has a great outlook and it would be good to synchronise that outlook”, said Wiśniewski.

A win-win and profitable partnerships

Anna Gołębicka, an economist, healthcare communication strategist, and expert at the Adam Smith Centre, underlined that the potential of the Polish pharmaceutical industry is still untapped.

“The industry has a huge capacity to produce critical drugs, as repeatedly declared by Polish drug manufacturers. It can guarantee our drug safety to a much greater extent than it does now. It also has the potential to develop and produce Polish APIs (active pharmaceutical ingredients). However, this requires goodwill and dialogue with the government. Having said that, I recall the paradigm perpetuated by negative PR that pharmaceutical companies supposedly only care about profit. We need to overcome this paradigm because in the current geopolitical situation, unless we come up with a sensible win-win that works for the industry and the government, we could soon end up in a much more difficult situation”, warned Gołębicka.

Professor Marcin Czech agreed.

“We need to overcome the paradigm of the big bad pharmaceutical companies and think about public-private partnerships. From my experience as minister, it is much easier for ministers to manage a crisis if the partners are in Poland or Europe rather than far away in China or India. The public-private partnership works for both parties: the minister can ensure security for patients, while for the business partner, Europe’s ageing population with social healthcare systems offers more stability for the pharmaceutical business. The combination of a sick population and public systems that pay for treatment ensures predictability. Businesses can be sure of making money in a reimbursement system for many years, as long as they bring innovations that the ministry is interested in”, said Professor Czech.

Gołębicka added that predictability is the most important factor for business, including not only predictable profits but above all legal certainty.

“The stability of legal regulations is one of the key factors that large international companies consider when planning investments in a region or country. This is because they need to be sure that if they invest a lot of money in a factory or research, the investment will pay off. This is why any changes to European pharmaceutical law are so important for multinational companies”, the expert commented.

Participants in the debate agreed that it would be in Poland’s interest to complete work on the final shape of the reform before the end of the Polish Presidency of the European Union.