WARSAW, 13 Sep (APM) - Pharmacists in Poland are asking the government to consider lowering the value of its proposed fines for selling falsified drugs, reported Rzeczpospolita (pA12) on Wednesday.
According to recently proposed amendments to the country's laws on pharmaceuticals, from January 2020, a fine of 100,000 zlotys (€23,000) will be imposed on pharmacies and 500,000 zlotys (€115,000) on wholesalers for selling falsified drugs.
However, pharmacists say that there are tens of thousands of errors in the verification system throughout the country, meaning they may mistakenly face large fines.
According to Mariusz Politowicz from the Supreme Pharmaceutical Chamber (NRA), the proposed legal changes may result in pharmacists not selling particular drugs. The system that verifies the unique codes from the packs of drugs gives too many falsification alerts either because of its failure to detect the given drug or because of an invalid code.
Michał Byliniak, vice president of the NRA and president of the Pharmaceutical Group of the European Union (PGEU) agrees that fines for distributing falsified drugs are indeed necessary, but should not be introduced until the system is operating correctly. Janusz Cieszyński, deputy minister of health responsible for digitisation in healthcare, has announced that the fines will be reduced.
Polish pharma industry needs to commercialise domestic research
The Polish pharma industry needs to commercialise domestic research, as many patents and innovations are commercialised abroad, stakeholders said at the Economic Forum in Krynica, as reported in Rzeczpospolita (pA23, pA25) on Monday and (pA25-A28) on Tuesday and Dziennik Gazeta Prawna (A12) on Tuesday.
The discussion include how scientists can take advantage of several organisations, including the recently created Virtual Research Institute, a biomedical institute subsidised by the government with 500 million zlotys (€115 million); the newly formed Medical Research Agency (ABM); or the National Centre for Research and Development (NCBiR), which has recently broadened the scope of its grants to include clinical trials,
Another topic was the number of partnerships between the National Health Fund and pharmas in monitoring and making changes to the reimbursement policy of cancer therapies based on their effectiveness. This will contribute to more patients gaining access to innovative treatments in the near future, reported Rzeczpospolita on Monday and Dziennik Gazeta Prawna on Tuesday.
Amgen discussed working with the Medical Research Agency (ABM) on research, educational operations, the use of AI in healthcare, as well as commercial and non-commercial clinical trials conducted in Poland. According to Gábor Sztaniszláv, general manager of Amgen, Poland is in second place after the U.S. in terms of the number of patients entering clinical trials worldwide, reported Rzeczpospolita on Tuesday.
Vertex Pharmaceuticals suggested altering the criteria for reviewing drugs that are submitted for reimbursement, as many patients suffering from mucoviscidosis and other rare diseases do not have access to therapies because of the complicated processes and uneven criteria, added Rzeczpospolita on Tuesday
Pharma firm Adamed said the only solution for Polish drug producers to expand onto international markets is to gain a strong position and support from their home country through such programmes as the long-promised reimbursement incentives system (RTR), added Rzeczpospolita on Tuesday.
Selvita starts clinical trials for cancer drug SEL120
Selvita’s cancer drug, SEL120, has just started Phase I trials for the treatment of acute myeloid leukaemia and high risk Myelodysplastic syndrome at U.S. medical centres, reported Parkiet Gazeta Giełdy (p5) on Saturday.
Selvita expects the first results of the clinical trials as early as in 2020.