WARSAW, Sep 15 (APM) - The Polish Ministry of Health (MoH) admits that, despite all the recent regulatory changes, the problem of parallel exports is continuing, which will necessitate the introduction of additional restrictions, reported Dziennik Gazeta Prawna (pB4) on Thursday.
The chief pharmaceutical inspectorate (GIF) conducted a detailed analysis of the process of illegal drug exports in 2016 and in the first half of 2017, auditing 160 pharma wholesalers.
Pawel Trzcinski of the GIF said there were irregularities in all 160 cases, but not all of them applied to drug exports. The problem is that many wholesalers use several IT systems for legal and illegal transactions and, during audits, only give the auditors access to the system not containing illegal activities. Dishonest wholesalers are also moving away from exporting drugs through pharmacies to selling them through outpatient clinics, which are much more difficult to audit.
The officials are currently working on additional regulations to prevent pharma wholesalers from owning outpatient clinics. Additionally, the GIF will gain access to the system of monitoring the transportation of goods and all companies intending to transport any medications abroad will be required to notify the GIF. The GIF will have the authority to fine entities failing to do so, or stop the transportation if the officials suspect it contains restricted drugs.
Important ruling on a ministerial conflict of interests
The administrative court in Warsaw ruled on June 20 that officials who had previous ties with a particular pharma company applying for reimbursement should not be able to assess its applications due to a potential conflict of interests, reported Rzeczpospolita (pC5) on Wednesday.
The ruling applies to a case of a pharma company producing a drug containing diosmin, the reimbursement application of which was rejected by the MoH. Meanwhile, the final decision was signed by a deputy minister who, before joining the MoH, worked with the company on preparing the reimbursement documentation.
The court ruled that, in such cases, officials with a potential conflict of interests should not be part of the committee responsible for assessing reimbursement applications. Experts say the ruling is extremely important and shows the MoH should create a transparency system, as many officials working there have had previous ties with pharma companies.
The MoH announced that it would not appeal against the court’s decision.
Hospitals will be incentivised to buy cheaper hepatitis C drugs
The national health fund is planning to pay bonuses to hospitals which manage to purchase hepatitis C drugs used in the non-interferon-based drug programme for less than 27,000 zlotys (6,323 euros), which places a question mark over the national tender for buying such medicines, reported Rzeczpospolita (pC6) on Monday.
Experts claim this step is a clear sign that the ministry of health no longer intends to organise tenders and patient organisations are concerned that the regulations could result in patients being treated with poorer quality drugs.
The new regulations are currently under discussion.
State will pay for children’s vaccination complications
According to the new regulations prepared by the MoH, the state will compensate parents for children’s vaccination complications, reports Rzeczpospolita (pA1 & pC1) on Friday.
The maximum amount payable to parents will be 70,000 zlotys (16,355 euros) and the MoH estimates the number of cases subject to compensation at ten per year. However, the STOP NOP anti-vaccination organisation claims the number of such cases could be as high as several hundred and that the estimates of the officials cannot be accurate, as the system for reporting such cases is ineffective.
Despite the compensation being paid, parents will still be entitled to go to court. The compensation fund will be financed by pharma companies supplying vaccinations used in the obligatory vaccination programme and its limit is estimated at 2.5 million zlotys (584,100 euros) a year.
Dangerous weight-loss pills
At least 3,800 patients bought illegal and dangerous Meridia weight-loss pills containing sibutramine, sold for the past three years by a recently uncovered criminal organisation from Szczecin, reports Dziennik Gazeta Prawna (pA21 & A22) on Friday.
Sibutramine was banned from sales in the EU by the European Medicines Agency in 2010, as testing showed that the drug can dramatically increase the risk of cardiovascular incidents. Most of the illegal sibutramine pills available in Poland can easily be bought online at a price of around 250 zlotys (59 euros) for a monthly treatment. The drugs are mainly smuggled in from countries such as Bangladesh, China and Vietnam.
It is estimated that up to 200,000 Poles could be buying illegal weight-loss pills online each year, of which many are either dangerous or do not contain any medical ingredients at all.
The chief pharmaceutical inspectorate admits the officials are powerless in fighting the issue and says the only hope lies in the customs authorities intercepting packages containing illegal medications.
Promising acute lymphoblastic leukaemia drug
The U.S. Food and Drug Administration has officially approved Novartis’ Kymriah for treating acute lymphoblastic leukaemia, reported Rzeczpospolita (pA14) on Wednesday.
Kymriah is a personalised drug using genetically modified T lymphocytes obtained from the patient’s blood to effectively fight leukaemia cells. According to Novartis, the drug is effective in 83% of cases, but can only be administered to patients aged over 25 and can result in cytokine release syndrome.
While the treatment is extremely expensive and costs $475,000, it could be the only chance for many acute lymphoblastic leukaemia patients. 3,100 U.S. patients aged under 20 are diagnosed with the disease each year, of whom 15-20% do not respond to standard treatment at all.
Biomed-Lublin is sells brand, boosts production capacity
Biomed-Lublin could soon sell its rights to the Lakcid probiotic brand and intends to increase the production capacity of its Onko BCG product line of drugs for non-invasive bladder cancer, reports Parkiet Gazeta Gieldy (p4) on Friday.
Marcin Pirog, Biomed’s CEO, said the company received three interesting offers for Lakcid and could soon choose a potential partner. He added that the company is prepared to triple production of Lakcid and that the first contract with the new sales partner could be signed for up to seven years, starting January 1.
Biomed is also investing 600,000 zlotys (140,200 euros) to triple the production capacity of its Onko BCG product line by September 2018.
Pirog admitted that the biggest challenge faced by the company is the debt of 102.5 million zlotys (24 million euros), partially arising from its failed project of setting up a blood plasma fractionation plant in Mielec. He added that the company’s priority is to regain the trust of its investors and present an entirely new business strategy for the forthcoming years by the first quarter of 2018.
GlaxoSmithKline is major investor in Poland
Puls Biznesu published an interview with Krzysztof Kepinski, board member and head of external relations at GlaxoSmithKline on the company’s investment strategy in Poland, reported Puls Biznesu (p10) on Tuesday.
Kepinski said the company values Poland primarily for its human resources and stable economic environment, as well as the pro-development approach of the officials.
He welcomes the idea of connecting reimbursement decisions with the commitment of pharma companies to the development of Polish industry, as GSK is a major contributor to the Polish economy, with 250 million zlotys (58.6 million euros) paid in taxes every year and 90% of its 2,400 suppliers being from Poland. Kepinski added that the value of drugs produced in GSK’s plant in Poznan and exported to 120 countries is roughly 4 billion zlotys (937 million euros) per year.
Kepinski said the company invested 100 million zlotys (23.4 million euros) in its plant in Poznan last year, mostly in the area of HIV/AIDS medicines, and confirmed that decisions on further investments in Poland could be made shortly.