debate: Reform of pharmaceutical law as a challenge for the Polish Presidency

Changes that Benefit Patients

The European pharmaceutical package aims to guarantee Europeans equal access to treatment. To achieve this, the interests of innovative and generic drug manufacturers must be balanced.

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.