WARSAW, 19 July (APM) - Despite the health minister's promises that drug shortages in Polish pharmacies would be resolved shortly, access to numerous medicines is still restricted, reported Dziennik Gazeta Prawna (pB6) and Rzeczpospolita (A1 & A11) on Monday, Dziennik Gazeta Prawna (pB1), Rzeczpospolita (A1 & A16) and Gazeta Wyborcza (p1-2) on Tuesday, Gazeta Wyborcza (Stoleczna supplement, p4) on Wednesday and Rzeczpospolita (pA13) and Dziennik Gazeta Prawna (pA5) on Friday.
Pharmacists and patients warn access to various doses of Euthyrox, Fraxodi, Metformax SR 500, Glucophage, Valsartan HCT Mylan, Clexane Forte, Effox, Dexilant, and dermatology drugs is limited, which often forces patients to cover long distances to buy them, reported Dziennik Gazeta Prawna and Gazeta Wyborcza.
Simultaneously, patients complain the nationwide helpline launched on Monday is of little use, as the operators only advise patients to verify drug availability in pharmacies, reported Dziennik Gazeta Prawna, Gazeta Wyborcza and Rzeczpospolita.
Pharmacists claim there is a desperate need for a systemic solution enabling the monitoring of drug availability in Poland and the preparation of emergency plans in case of shortages, as is already the case in the U.S. and shortly in France, reported Rzeczpospolita.
Marcin Tomkow, vice-president of the Supreme Pharmaceutical Council, says there are signs that drugs are being traded online or among neighbours, which is not only illegal, but also potentially dangerous. He added that access to drugs is better in pharmacy chains because of their preferential deals and it is important to supply more small packs, as pharmacists can sell smaller packs than prescribed, but never larger ones, reported Rzeczpospolita on Monday.
Tomkow says the officials should stop claiming the drug availability crisis has been resolved before appropriate access to all medicines is restored throughout Poland. Barbara Misiewicz-Jagielak, vice-president of the Polish Association of Pharma Industry Employers (PZPPF) agrees and adds the situation would not be so critical if more drugs were produced in Poland and the industry was less reliant on active ingredients from China.
She said the Polish industry is still waiting for the long-promised incentives system for companies producing drugs in Poland, which is stuck in the Ministry of Health (MoH) and that another, faster solution would be to end the constant price pressure applied by the officials during reimbursement negotiations, which forces pharmas to cut corners and encourages them to use the cheapest, Asian suppliers, reported Dziennik Gazeta Prawna.
Michal Byliniak, president of the regional pharmaceutical chamber in Warsaw said that, although the Masovian voivodship has over 1,700 pharmacies, several hundred pharmacies there report problems with drug availability.
He added that the current crisis is a result of illegal drug exports, a dependency of the industry on Chinese suppliers of active ingredients, new anti-counterfeiting regulations affecting drug labelling and price pressure, making drug sales less profitable for pharmas than in many other European countries, reported Gazeta Wyborcza.
Deputy health minister Janusz Cieszynski announced the appointment of a standing drug supply monitoring team, consisting of representatives of the pharmaceutical and medical chambers, the pharmaceutical inspectorate and the National Health Fund, report Rzeczpospolita and Dziennik Gazeta Prawna on Friday.
Neuca, Poland’s leading pharma wholesaler published information on the availability of 10 drugs to which access is restricted. It said that its orders on pharmas are not being fulfilled, while its stocks have been drastically depleted, report Dziennik Gazeta Prawna on Friday.
Regulations on illegal exports will be less restrictive for institutions
The MoH decided to amend the regulations on illegal exports to make them less restrictive for institutions, such as schools, orphanages and nursing homes, reported Rzeczpospolita (pA12) on Monday and Dziennik Gazeta Prawna (pB6) on Tuesday.
According to the regulations which recently took effect, pharmacies are only allowed to sell drugs directly to individuals or medical institutions. Sales to anyone else create the risk of criminal liability.
This means many institutions are not legally able to buy medicines in specific doses or products required to conduct day-to-day activities and receive an invoice. The MoH acknowledged this issue and decided to account for such cases and rework the regulations so they are less restrictive for such institutions.
The officials are also encouraging pharmacies to not wait for the amendment to take effect, but to immediately start selling OTC drugs not containing psychoactive ingredients to non-healthcare institutions, as such products are not affected by illegal exports.
State Drug Policy needs to be put in action
The State Drug Policy 2018-2022 introduced in September 2018 is not effectively pursued, as not even half the planned projects have been introduced into Polish healthcare, reported Dziennik Gazeta Prawna (pB10) on Thursday.
Increasing access to new therapies, focusing more on prevention, establishing methods of avoiding drug shortages, either because of the current situation in China or because of illegal drug exports or the difficult and lengthy application of serial numbers to new batches of medications and improving the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL) are points for improvement with the growing needs of pharmaceutical care for Poland.
Poland needs to regulate plasma market
Plasma used for producing albumins, immunoglobulins and clotting factors used in haemophilia, primary or secondary immunodeficiencies, autoimmune diseases and severe systemic bacteria or virus infections, needs to be regulated in Poland, reported Rzeczpospolita (pA10-A11) on Thursday.
According to the Regional Blood and Haemotherapy Centre in Warsaw, 200,000 litres of plasma are collected each year and, according to the Supreme Audit Office (NIK), the poor management of the plasma surplus results in almost 9% of the annual requirement for plasma expiring and therefore being wasted.
The World Health Organization and European Commission claim each country should be self-sufficient in plasma production, but, in order to provide for the needs of Polish patients, many plasma-based drugs need to be imported.
The MoH announced the start of work on managing plasma reserves on 16 April. Experts say there are two solutions: to build a private or public-private partnership plasma fractionation plant or organise a tender with one provider to fraction all Polish plasma.
According to experts, 200,000 litres of plasma is insufficient to justify, in terms of cost, building a plant. The third option, introduced in the Czech Republic, is to buy plasma directly from hospitals and provide plasma-based drugs to them through a barter trade agreement (P4P - product for plasma model).
Imports of medical cannabis will increase in autumn
The Canadian Spectrum Cannabis, currently rebranding to Canopy Growth and the only licensed importer of medical cannabis in Poland, will increase shipments to 100 kilogrammes a month in the autumn, reported Puls Biznesu (p2) on Wednesday.
The company currently offers only the 19% THC variety of the product, but should soon register the 10% THC and 9% CBD varieties that are better suited for cancer patients.
Once this happens, Canopy Growth intends to supplement its product range with another variety of dried product and its first CBD oil. Tomasz Witkowski, the company's country manager in Poland, said negotiations with the largest pharmacy chains are close to completion and, with increased shipments, patients should no longer have any problems obtaining cannabis-based drugs.
Canopy Growth is expecting to start generating a profit in six months and is currently battling with the fiscal authorities which imposed a 23% VAT rate on medical cannabis, even though other medicinal products are sold with an 8% VAT rate.
Public consultations for Pharmaceutical Profession Bill
The bill on the pharmaceutical profession increasing the importance of the role of the pharmacist and introducing pharmaceutical care has entered public consultations, reported Dziennik Gazeta Prawna (pB4) and Rzeczpospolita (pA17) on Thursday.
The long-awaited pharmaceutical care will allow pharmacists to extend their current role of vendors of medications and to advise patients on the choice of drug, review their current medications and perform simple diagnostic tests, such as measuring blood pressure. However the bill does not include any increase in outlay by the MoH for this pharmaceutical care, added Dziennik Gazeta Prawna.
The bill also states that pharmacists should only be guided by the patient's wellbeing and not be influenced by their managers. This should end the practices of pharmacists being forced to promote certain drugs or supplements. Nevertheless, the bill does not mention sanctions for such practices, but introduces pharmacist-patient confidentiality, reported Rzeczpospolita.
Pharmaceutical inspector revokes pharmacy licence
A ruling of the Supreme Administrative Court upholding the revocation of a pharmacy licence and dismissing a cassation complaint has been issued for a pharmacy conducting wholesale trading of cardiac, oncology, optical, diabetes, ophthalmic, neurology and anticoagulant drugs as it is illegal for a single entity to operate a pharmacy and conduct wholesale trade, reported Rzeczpospolita (pA17) on Thursday.
Synektik included in WIGtech
Owing to its rapid growth and business agility, Synektik has been included in WIGtech, a new Polish stock market index containing growing innovative technological companies, reports Parkiet Gazeta Giełdy (p7) on Friday.
Synektik researches and implements new technologies, such as Apoteca Chemo robotic systems used in the production of chemotherapy drugs. It currently exports some of its radiopharmaceuticals to neighbouring countries, as well as Scandinavia and France.
Synektik also conducts R&D work on radiopharmaceuticals, such as a cardiology tracer that has recently passed Phase II. This tracer is used in positron-emission tomography (PET-CT) in non-invasive diagnoses of diseases such as coronary artery disease and its progressions.
Synektik's cardiological tracer is planned to be more innovative and long-lasting than other radiopharmaceuticals, which will enable the popularisation of PET-CT diagnoses.
Bioton signs contract with Yifan Pharmaceutical
Bioton has signed a deal with China's Yifan Pharmaceutical on the production of insulin analogues, reported Parkiet Gazeta Gieldy (p4) on Wednesday.
Bioton's chief executive, Robert Neymann, said Yifan would cover the cost of adapting the company's production line, purchasing the substances required to mass-produce active ingredients and, at a later stage, will finance all costs of manufacturing the final products.
He added that the agreement is a milestone for launching insulin analogues under Bioton's brand name.
If Bioton's production line is adapted successfully, the company will gain the right to use Yifan's intellectual property to produce and exclusively distribute insulin analogues in Poland for 25 years.
Bioton is currently Poland's leading insulin producer and one of eight companies in the world producing recombinant human insulin.
Selvita's split 'will increase focus'
Selvita, a Polish biotech listed on the Warsaw stock market, will be split into two entities in the last quarter of the year to better focus its activities, reported Parkiet Gazeta Gieldy (p4) on Monday.
Selvita currently runs two distinctively different businesses simultaneously, with differing strategies. On the one hand, it conducts drug R&D for third parties, which generates profits to keep the business going, while on the other, its innovative segment generates very high costs and is much more risky.