WARSAW, 21 Jun (APM) - Recent changes in the Chinese environment regulations have led to the closure of several large factories of active substances which will have a major impact on the Polish pharma industry, Dziennik Gazeta Prawna (pA1, pB6) reported on Monday and Tuesday (pB4).
According to Krzysztof Kopeć, president of the Polish Association of Pharmaceutical Employers, up to 80% of active substances used in Polish drugs come from China.
The largest companies, such as Polpharma, have diversified their suppliers, but the majority of Polish pharma are struggling to obtain the necessary ingredients because of the situation. They have treated Chinese producers as their sole source of active substances because they offer the lowest prices, enabling them to remain competitive on the difficult pharma market.
Around 100 drugs are already unavailable in Poland.
Tomasz Latos from the Sejm’s Health Commission says the problem has not only an economic impact, but also has safety implications. Polish pharma firms should not be forced to use the cheapest ingredients, but should be encouraged to produce active ingredients locally, he said. Such production may be far more expensive than importing the substances from abroad, but the ingredients imported from Chinese factories are not tested according to the safety standards and there have already been incidents of their contamination, he said.
To avoid such risks, Latos suggests offering tax relief for local production of active substances and standardisation of the regulations for imports and the use of Chinese substances not only locally in Poland, but throughout the EU.
Polish oncology experts propose regulatory changes to improve cancer treatment
Polish oncology experts said that, without amendments to the healthcare and reimbursement legislation, as well as Ministry of Health (MoH) support for pathomorphological institutions, Polish patients will never have proper access to the latest cancer therapies, reported Rzeczpospolita (pA8) on Tuesday.
The comments were made during a debate on what needs to be changed in Polish legislation to allow for the use of precision medicine for “cancer as a genome disease".
Precision medicine is a new approach in which therapies are tailor-made for each patient.
Poland has a problem with access to individual genome tests which are required to prescribe specific treatment. Furthermore, precision medicine stands in opposition to the Polish drug registration system, which is targeted at larger groups of patients.
Individual patients, who are not part of larger tested groups have limited access to the reimbursement of the most optimal therapy available. An example of this is rituximab, a lymphoma treatment registered and reimbursed in four types of lymphomas, but also recommended in many more.
Alternative ways of reimbursing therapies include the orphan medicine procedure that can be registered for smaller groups of patients or, as a last resort, emergency access to drug technologies (RDTL) introduced in 2018 which, according to experts, also needs further legislative work.
Not only is financing a barrier for precision medicine, but there is also a lack of quick access to quality genome and pathomorphological tests. Patients often receive chemotherapy before being properly tested and, even if their results speak against it, they need to continue the debilitating procedure once it starts. To improve this problem, the MoH would have to give accreditation to pathomorphological centres and allow them to conducti diagnostic tests from the MoH’s budget.
The experts agreed that both pathomorphological and genome tests need to go hand in hand as they can only collectively show the complete picture of the disease and save thousands of zlotys on chemotherapy that is simply not applicable to every case of cancer.
Illegal export regulations need amendment
The new regulations on illegal exports must be changed because of the legal inconsistency regarding the ability of pharmacies to sell drugs to orphanages and other welfare institutions, Dziennik Gazeta Prawna (pB5) reported on Tuesday.
According to the new regulations, pharmacies are only allowed to sell medicines to individual patients, while sales to institutions and businesses are illegal. Consequently sales to welfare centres and orphanages may be punishable with up to eight years’ imprisonment. The only risk-free method of supplying medicines to these institutions is to provide them free of charge.
The MoH disagreed with the claims of the Association of Pharmaceutical Employers, PharmaNET, and the Polish Ombudsman that it is currently impossible to sell medicines to such institutions, explaining that such purchases are made on behalf of individual patients and would therefore be treated accordingly.
However, because pharmacists do not want to risk facing criminal charges, the MoH has announced that an appropriate amendment to the regulations will be introduced.
Biomed's profits rise despite BCG 10 vaccine problems
Biomed returned a net profit of 207,300 zlotys (€48,570) in the first quarter of the year, despite its recent problems with the BCG 10 tuberculosis vaccine, Parkiet Gazeta reported Gieldy (p5) on Saturday.
Biomed had to suspend sales of its BCG 10 vaccine in January due to suspected problems with the manufacturing process. Even so, it still managed to generate a profit because of the high sales of its flagship product, Disreptaza (streptokinaza+streptodornaza), used for treating haemorrhoids and chronic inflammatory diseases of the appendages.
Biomed is currently focusing on increasing its productivity by changing glass ampoules to phials which are supposed to improve safety of use of its drugs, as well as expanding its portfolio. Another of the company’s products, Onko BCG (live attenuated Bacillus Calmette-Guerin), has proved effective in treating diabetes, but the company needs to perform additional tests to confirm and possibly increase the effects of treatment.
Biomed has disclosed its plans to settle its debt by 2023 and to develop its land in the centre of Warsaw for residential construction and production buildings. It also plans to build an R&D centre for which it received a grant of 15 million zlotys (€3.51 million) last year.