Polish government, business associations respond to EU pharmaceutical law reform

Following the EC's announcement of the European Pharmaceutical Strategy, the Polish government and the country’s business associations are conducting consultations on the issues raised by this move. A meeting of the government’s Commission for European Union Affairs (EUA) was held on 19 October 2023, and during it, Undersecretary of State Maciej Miłkowski presented the Polish government's position on the proposed changes.

Here are the main points of how Poland’s national authorities view them:

1. The Polish government approves in principle the idea that changes in the EU pharmaceutical law must be adopted to increase the competitiveness of Europe's pharmaceutical industry. It also recognizes the challenges posed by the lack of availability of drugs and antibiotic resistance on the EU market. At the same time, the government acknowledges that the individual solutions proposed by the European Commission need to be clarified to accomplish the goals that have been set. It aims to strike a balance between innovation and generic medicines.
2. The most important public authority goal is to increase drug availability for patients without supporting a specific group of manufacturers. To achieve this, the government backs the further extension of the Bolar exemption. It will also push for a reduction in the data exclusivity period from eight years at present to six years in the future. It will not support the proposed conditional extension of the data exclusivity period to a maximum of 13 years.
3. The validity of the tools proposed by the Commission to combat antibiotic resistance has been acknowledged, but the Polish government believes that for such tools to be effective, the definition and criteria for granting an availability category for antimicrobials must be clarified. The Polish government will seek to define antimicrobials as those requiring prescription-only status.
4. Despite many objections from generic companies, the Polish government is open to the introduction of a Transferable Exclusivity Voucher (TEV) aimed at promoting the manufacture of new antibiotics by extending the data exclusivity period for an additional year. It also comes out clearly in favour of the European Commission's proposal not to provide subsidies for antibiotic products, despite lobbying for the introduction of a model similar to that currently in place in the UK or Sweden.
5. In terms of environmental protection, the Polish government believes that the proposed solutions, especially with regard to wastewater treatment, are unduly restrictive, creating the risk of additional unjustified barriers to access to potential effective safe treatments for EU citizens. The challenges posed by such regulations have been acknowledged, as they may have a significant impact on European pharmaceutical industry production of any drugs, leading directly to an increase in production costs. It is noted that the proposed legislation may prevent the production and introduction of new highly effective, breakthrough medicines on environmental grounds. Such outcome will undermine the primary objective of the proposed directive, which is to elevate the protection of human health.

It should be noted that the Polish government's position on the Pharmaceutical Package may change shortly as a result of the stepping down of the ruling party in Poland: Having won the parliamentary elections held in October 2023, the opposition is now in a position to form a new government.

A week after the government announced its position, a stance on the matter was published by the Lewiatan Confederation , which is Poland’s largest business association and represents more than 4,100 Polish companies employing more than one million people. The importance of the Lewiatan stance on the EU reform proposal lies in the fact that the Polish Association of Pharmaceutical Industry Employers, which represents 18 of the country's leading and primarily generic pharmaceutical manufacturers, is also the member of the organisation.

Furthermore, the boards of both associations are mostly composed of the same people, who support the same interest groups. It can therefore be assumed that the position of Lewiatan corresponds to that of the national pharmaceutical industry. Here are the main points of its stance:

1. By way of a general observation, the Lewiatan Confederation points out that the consistent strengthening of IP protection witnessed by Europe over the past 30 years has failed to increase the availability of drugs and to foster the development of innovative medicines in the region. This, in its opinion, exposes the falsehood of the assumption that 'more monopoly leads to more R&D'. On top of that, it asserts that these monopoly measures have directly contributed to the relocation of drug production outside Europe. Therefore, the EU’s efforts to correct this by reforming Pharmaceutical Law reforms are to be applauded.
2. The business association opposes the extension of regulatory exclusivity periods. In the organisation's view, the newly proposed rules for granting protection are too vague and introduce uncertainty as to when it will be possible to sell a particular competing medicine. The organisation wants to see a maximum and uniform data exclusivity period of six years and market exclusivity of a basic two years. It has been proposed that market exclusivity could be extended by additional incentivization periods currently provided for in the draft directive, but the total duration of registration protection should not be longer than the currently available exclusivity periods, the longest being 11 years.
3. The proposal to introduce a Transferrable Exclusivity Voucher is also opposed by the business association. It points out that a company launching a new antibacterial drug will be granted a 12-month exclusivity right, which it can use for another drug or sell to a third party. The proposed structure, while intended to encourage new antibiotics research and development may in fact create scope for abuse and anti-competitive behaviour, it maintains. Therefore, it is proposed that other methods for supporting the development of antibiotics should be considered. Sweden and the UK were held up as countries where, by contrast, effective tools have been introduced in the form of an annual revenue guarantee scheme encouraging antibiotic developers to invest in R&D by providing guaranteed revenues. The Swedish and UK models were cited as a practical and feasible solution, one that has been tested and has yielded positive results for pharmaceutical sector R&D. The association calls for the scrapping of the TEV institution and the replacing of it with the Annual Revenue Guarantee Scheme - developed by EU-Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections (EU-JAMRAI) - which rewards innovation while promoting responsible antibiotic consumption.
4. The business association comes out in support of clearer regulations that will explicitly indicate that the extension of either data exclusivity or market exclusivity is dependent on ensuring medicinal product market availability for patients. Such availability should not only mean placing the medicinal product on the market and ensuring supply to cover patient demand, but also obtaining reimbursement for it. At the same time, the withdrawal of an application for reimbursement in any of the member states should result in the rescinding of the exclusivity granted.
5. The business associations notes that in addition to the changes to the Pharmaceutical Package, the EU Parliament is currently conducting legislative work on the treatment of wastewater. This will have a significant impact on those European pharmaceutical industry players producing equivalent medicines (generics and biosimilars) by pushing up their production costs. According to the Lewiatan Confederation, this might create a competitive barrier and drive part of the pharmaceutical industry out of Europe, especially given Asian competition, which receives financial subsidies from governments on the one hand and is not subject to such stringent regulations on the other.

The reactions described above reveal how many differences there are between generic and innovative industries as well as the representatives of public authorities on the subject of the planned reforms. At the same time, it is worth noting that Poland is a country where the pharmaceutical industry - both generic and innovative - is highly important for the domestic economy. The discussion currently underway between Poland’s business communities and representatives of the public authorities can therefore serve as an example for the development of a consensus on a European scale. Whether such consensus-driven proposal actually emerges is something that we will see in the coming years.

The EU’s proposed legislative measures are now in the hands of co-legislators (the European Parliament and the Council), where they will be further discussed in the Committee on Environment, Public Health & Food Safety (ENVI). It is expected that negotiations at a technical level between country representatives might begin in late 2023 or at the beginning of next year.