WARSAW, 20 Sep (APM) - Prosecutor General, Zbigniew Ziobro, has distributed new guidelines for combating illegal drug exports to Polish prosecutors based on the amendments to the Pharmaceutical Law of 6 June, reported Dziennik Gazeta Prawna (pB4) on Thursday.
The amendments introduced criminal liability for illegal exports and reverse distribution chains, while introducing a penalty of up to 10 years' imprisonment for exporting drugs classified as not available.
According to the guidelines, the investigators should assess whether only individuals or organised criminal groups are involved in these activities and, when pressing charges, they should state the quantities, value and types of drugs illegally exported in order to assess the level of social damage.
Polish pharmacies still experience drug shortages
Despite the assertions of the Ministry of Health (MoH), pharmacies still have problems obtaining such drugs as euthyrox for patients suffering from hypothyroidism, the diabetes drug glucophage and several hypertension treatments, reported Rzeczpospolita (pA17) on Thursday.
The MoH says the drug crisis is over and is waiting for a new pharmacy supervision office that has been promised by the Law and Order (PiS) Party if re-elected.
Polish children need to be vaccinated with a 13-valent pneumococcal vaccine
The 9-valent pneumococcal vaccine used in Poland is sub-standard compared with other European countries, reports Dziennik Gazeta Prawna (pA14-A15) on Friday
Pressure from experts resulted in the MoH adding a pneumococcal vaccine to the list of obligatory vaccinations for children in 2017, but its price led to the choice of a 9-valent vaccine in a tender, which the National Reference Centre for the Diagnosis of Bacterial Infections (KOROUN) says has 35% efficacy for patients aged up to five (compared with 65% for a 13-valent vaccine) and is below the standards of other European countries such as Germany, France or Italy.
According to deputy health minister Maciej Miłkowski, the reports from KOROUN and other experts will be analysed in detail, together with the situation in other countries in further decisions when choosing a pneumococcal vaccine. Other representatives of the MoH want the 13-valent variant to be used for child patients from as early as the beginning of 2020.
Some 1.5 million deaths from pneumococcal infections are reported globally each year and over 1,000 infections are recorded in Poland. The number of deaths in Poland is unknown, as pneumococcal bacteria are the main cause of such infections as pneumonia, arthritis, pericarditis, meningitis, sepsis and other diseases which are ultimately identified as the cause of death instead of its primary cause, pneumococcal infections.
New oncology database will enable analysis of the efficacy of cancer treatment in Poland
According to the National Cancer Registry (KRN), a national database of Polish cancer treatments will be established by 2022 to collect and analyse data from KRN, the National Health Fund and hospitals, reported Gazeta Wyborcza (pp4-5) on Wednesday.
The data collected will help analyse the whole population of patients suffering from cancer and the efficacy of their treatments. The platform will be funded by a grant from the European Union estimated at 17 million (€3.9 million) zlotys.
Even so, experts say Polish patients do not have the same chances of fighting cancer as, for example, patients from France or the Czech Republic because of the lack of access to innovative therapies due to the decisions of the MoH. Of the 102 recommended cancer treatments, half have not entered the reimbursement system, 18 can be prescribed without any complicated procedures and 37 are a part of drug programmes, in which a patient needs to pass rigorous tests to participate.
Number of pharmacies in Poland continues to decline
The Pharmacy For The Pharmacist Act of 2017 applying formal, geographic and demographic restrictions on opening new pharmacies from 2018, has reduced the overall number of pharmacies in Poland to 13,900, while their numbers are falling at an increasing rate, reported Dziennik Gazeta Prawna (pA9) on Wednesday.
According to the Polish Pharmaceutical Chamber, the number of new pharmacies is mainly restricted by the number of pharmacists in Poland, as well as the high density of pharmacies in cities. Experts forecast a drop in the overall number of pharmacies in Poland to 11,000-12,000, the level from 2004-2005, which will reduce competition between pharmacies and could lead to an improvement of service. Experts say the trend suggests pharmacies will only open where they are truly needed.
Polish politicians agree to an apolitical healthcare treaty
During a pre-election debate, politicians from various Polish parties discussed topics such as the drugs crisis, drug mafias and illegal exports, general vaccinations and HPV vaccines for girls, as well as the need to create a unified apolitical healthcare programme to improve the situation of Polish patients, reported Dziennik Gazeta Prawna (pA6) on Thursday.
Mabion is hoping to improve its financial results with MabionCD20
Mabion reported no revenues and a net loss of 32 million zlotys (7.4 million euros) in the first half-year, but hopes to significantly improve its results in 2020, after MabionCD20 is authorised in Europe, reported Parkiet Gazeta Gieldy (p4) on Saturday.
The MabionCD20 cancer drug is the company's most advanced project, currently in the final stages of registration with the European Medicines Agency. Mabion is addressing all questions posed by the EMA and the agency should issue its final decision by the end of the year. As soon as MabionCD20 is registered in Europe, the company’s R&D department will focus on registering the drug in the U.S. and launching new projects.
Mabion is simultaneously working on two other drugs, MabionMS for use in multiple sclerosis and Mabion EGFR, for use in bowel, head and neck cancer.
DM PKO BP analysts estimate the company's revenues at 157 million zlotys (36.2 million euros) and net profit at 74 million zlotys (17.1 million euros) in 2020 after registration.
Biotts is working on less invasive ways of administering drugs
Polish biotech, Biotts, is working on innovative ways of administering drugs and announced cooperation with large, undisclosed pharma players, reported Puls Biznesu (p6) and Dziennik Gazeta Prawna (pL6) on Tuesday.
Biotts has filed three patent applications to date. The first is for a multifunctional transdermal carrier-Y for active ingredients used in cancer drugs, anti-inflammatory drugs and analgesics, helping increase efficacy up to tenfold and reduce the dose to one fifth, significantly reducing the risk of adverse effects.
The drugs are to be administered by a special patch without the need for injections. As Biotts will only be responsible for providing the carriers of the active ingredients, the solution could be licensed to pharmas or sold to a major player. The second patent application is for a similar product for applying cosmetics and the third is a carrier with a local anaesthetic ointment developed by the company, reported both newspapers.
Biotts is also working on a new method of administering substances that previously could not be administered in the form of pills, but refuses to reveal any details at this point, reported Puls Biznesu.
Pharmena's products available in new Asian markets
Pharmena's products have been launched in China, Hong Kong, Macau and Taiwan by its Chinese distributor via the T-mall Internet sales platform, reported Parkiet Gazeta Gieldy (p4) on Tuesday.
The company believes this could have a significant impact on sales of its products in Asia over the coming few years.
Purdue Pharma files for bankruptcy
Purdue Pharma filed for bankruptcy on Sunday, following over 2,600 suits from various states, cities, counties and other entities claiming the company and its opioid drug, OxyContin, contributed to opioid addiction and cost almost 400,000 lives in the U.S. between 1997 and 2017, reported Gazeta Wyborcza (p8) and Dziennik Gazeta Prawna (pA16) on Tuesday.
Purdue Pharma is accused of aggressive marketing of its analgesics without giving sufficient warnings to doctors and patients about the potential risks of addictions and overdosing. Last week, the company announced it had come to an initial agreement with most plaintiffs, although numerous entities then rejected the deal, wanting higher settlements.
The Sackler family controlling the business offered to pay $3 billion and an additional $1.5 billion from the sale of a subsidiary, Mundipharma, but the plaintiffs rejecting the deal claiming it was insufficient. Steve Miller, Purdue Pharma’s CEO, said if the agreement is not accepted, the plaintiffs have to prepare for a long court battle and high legal costs adversely affecting the company’s financials and hence settlements. The company also says OxyContin was approved by U.S. officials, reported the newspapers.
Purdue Pharmaceuticals is not the only U.S. company facing legal problems with opioid sales. New York's public prosecutor accused one of the 10 largest pharma distributors in the U.S., Rochester Drug Cooperative, in April, of deliberately breaching the anti-narcotics regulations by distributing highly-addictive opioids between 2012 and 2016, reported Gazeta Wyborcza.
An estimated 750,000 U.S. patients have died from opioid overdoses since 1999, of whom 68% had their drugs prescribed by doctors. The U.S. Medicaid healthcare system spends $8.4 billion a year on treating addictions, while the total social cost of opioid addition could be as high as $78.5 billion a year, reported Dziennik Gazeta Prawna.