Press review


EU needs to become independent of Chinese APIs, Polish experts say

Country : China, France, Germany, India, Netherlands, Poland, U.S., UK

Keywords :
WARSAW, 13 Dec (APM) - Medicines for Europe (MFE), an organisation associating top generic producers in the European Union, has appealed to the European Commission to start working on solutions to become independent of the active pharmaceutical ingredients (API) imported from Asia to prevent the drug shortages crisis, reports Dziennik Gazeta Prawna (pA1, pA5) on Monday, (pA4) on Thursday and (pA6-A7) on Friday.
According to experts in Poland, such an appeal shows the gravity of the problem, and that the EU might soon face "pharma wars" arising from shortages of APIs. Almost 80% of drugs sold within the EU currently contain APIs from China or India.
The Polish drug crisis in the summer originated from the closure of a dozen large API producers in China for ecological reasons. Experts say 500 different drugs were unavailable on the Polish market at the turn of June and July due to the crisis. Some of this is the effect of illegal drug exports from Poland, which is estimated at 2 billion zlotys (€470 million) a year.
MFE is appealing to the European Commission to search for a solution to prevent further drug crises, such as moving API production to within the EU, as the problem of patient safety is not economic, but political, reported the newspaper on Monday.
Currently, according to portal, which monitors 1,000 out of a total of 16,000 pharmacies in Poland, the list of unavailable drugs has increased by 10 to 50 overall. The patients affected are type 2 diabetics using metformin, supplies of which are now limited because of possible NDMA contamination.
One metformin producer, Merck, claims its API is produced in France, but the next batch to be supplied is planned for early 2020. Although no contamination was confirmed in their products, both Bioton and Polpharma have suspended production and distribution of their drugs as a pre-emptive measure.
According to deputy health minister Maciej Miłkowski, one solution to preventing shortages of diabetes drugs is to add new long-acting therapies to the reimbursement lists to diversify the therapies.
Another group of patients affected by the drug shortages are those suffering from thyroid diseases. Drugs containing iodine, Novothyral and Euthyrox N 88 are difficult to obtain. According to Merck, a new batch of Euthyrox N 88 was to be shipped on 2 December, but has not become available so far. Furthermore chemotherapy products used in oncology and certain analgesics are in short supply.
There is also a problem with the availability of measles, smallpox and HPV vaccines in pharmacies although those included in the obligatory vaccination plan are available.
According to the Ministry of Health, the drug situation is under control, but the experts recommend amending the pharmaceutical law, which would require pharmas to hold additional two to three months of stocks.
According to recent reports from the U.S. Food and Drug Administration (FDA), the substances produced in Chinese pharma plants are made in dreadful conditions, where the staff often does not have access to running water, soap or toilet paper. The actual conditions of production are almost impossible to control, so further possible drug contamination is impossible to detect, which could consequently compromise patient safety. The experts see this as a long-term result of the global trend of pharma price reductions, where cheap drugs come at the cost of patient health, concluded the newspaper on Friday.

Ministry of Health plans free medicines for pregnant patients

The new government is continuing work on draft laws from the times of the previous government, with one amendment to the pharmaceutical law constituting the introduction of free medications that are most commonly used by pregnant patients, reported Dziennik Gazeta Prawna (pB11) on Wednesday.

Polish patients do not have equal access to birth control

According to a report prepared by a group of non-governmental organisations, the Polish Ministry of Health (MoH) and the National Health Fund (NHF) are breaching women's reproductive rights in Poland, reported Gazeta Wyborcza (p9) on Tuesday, (p1, p9) on Thursday and (p19) on Friday.
The report claims only one in three Polish patients have access to modern birth control and the NHF reimburses only two types of contraceptives and only 350,000 packets a year. Other means of birth control, such as patches, pills and IUDs, together with anaesthesia during delivery, in vitro fertilisation and sometimes gynaecological visits and procedures are only available commercially, which creates an economic gap and unequal access to these for female patients in Poland, reported the newspaper on Tuesday.
The Abortion Supply Network (ASN) foundation, an organisation a member of the Abortion Without Borders (AWB) global organisation, opened an abortion fund for women in Poland this Wednesday. This organisation will help women to apply for help, transport and organisation of the procedure in Germany, the Netherlands or in the UK. An international organisation called Women Help Women will supply abortifacients to Poland. The organisation's objective is to give patients access to a choice of procedures, reported the newspaper on Thursday.
The start of AWN's operations immediately encountered strong opposition from the conservative organisation, Ordo Iuris, which has already filed a report with the district prosecutor about the suspicion of the commitment of a crime. The AWB does not see any legal grounds on which their operations are in conflict with Polish law and claim that the report will only serve the purpose of stigmatising women who are looking for their help, adds Wyborcza on Friday.
The costs of one abortifacient is around €70 and the cost of an abortion is between €450 and €1,000, reported the newspaper on Thursday.

Warsaw fighting diabetes with Cities Changing Diabetes programme

Cities Changing Diabetes is a global diabetes prevention programme for populations of large cities that has recently been inaugurated in Warsaw and is one of the current strategies for fighting the wave of diabetes, reported Rzeczpospolita (pA10) on Tuesday.
According to the National Health Fund (NHF) the Polish Government spends 2 billion zlotys (€470 million) on combating diabetes each year: 49% are costs of medication, 25% glucose test strips, 20% diabetes-related services and 4% are insulin pumps and continuous glycaemic monitoring systems.
Furthermore, since November, flozines, innovative treatments for diabetes, are reimbursable for patients suffering from type 2 diabetes before the introduction of insulin and who have been treated with at least two oral hypoglycaemic agents with at least 8% glycated haemoglobin and who suffer from high-risk cardiovascular diseases.

Anti-vax movement causes return of measles and smallpox

According to the Polish National Institute of Health (PZH), 44,475 people refused to vaccinate their children in the first three quarters of 2019 , which is 4,000 more that throughout 2018, reported Dziennik Gazeta Prawna (pA4) on Monday and (pA6) on Wednesday.
The experts see the reason for the alarming trend, especially with the rising incidence of measles and smallpox globally, in actions organised by the anti-vax movements, who post solutions and tips online on how to avoid being vaccinated.
This has led to a decline in vaccinations below the level that prevents the diseases from spreading. According to the World Health Organization (WHO), the vaccination coverage level for measles should be 95% of the population that is to be vaccinated, whereas it is currently 93% in Poland. The Ministry of Health (MoH) has suggested it will change the compulsory vaccination regulations. Additionally, every refusal to vaccinate, justified and not, is currently reported to the sanitary and epidemiological station, reported the newspaper on Monday.
According to research conducted by the medical students from the Medical University of Gdańsk into 18,000 online posts on the STOP NOP anti-vaccination movement’s website, most of the communication contains conspiracy theories and misinformation based on wrongly interpreted research, leading to concerns about safety and the implicit breach of human rights caused by the vaccination obligation.
Another strong group among anti-vaxxers were the proponents of natural medicine. Religious reasons were a minor reason for not vaccinating. The objective of the research was to understand the thoughts and emotions of the anti-vax groups so as to develop a targeted promotional and educational pro-vaccination campaign strategy, added the newspaper on Wednesday.

Vaccination scandal awaits resolution

Despite appeals from the Prosecutor General, Zbigniew Ziobro, the vaccination scandal that took place in the Lubuskie voivodship in the fourth quarter of 2017has not been resolved, reported Dziennik Gazeta Prawna (pA7) on Tuesday.
The scandal applied to several hundred patients, mainly children and infants, who were vaccinated against hepatitis B, meningococcal and pneumococcal infections, tetanus, tuberculosis, rabies and chickenpox which were planned for disposal.
The vaccinations should not have been used because of the power cuts resulting in the vaccines not being stored in appropriate, cool conditions. Even so, rather than wasting so many costly vaccines, the staff decided to administer them to patients. Meanwhile the local authorities only ordered an expert opinion from medical examiners from the Poznań University of Medical Sciences, which will constitute the basis of the decision on whether the investigation is to be continued or not.
According to the deputy president of the Supreme Pharmaceutical Chamber, such delays can cause unclear situations regarding the sensitive topic of vaccination and can cause even further declines in the rates of vaccination in Poland.
According to the Chief Sanitary Inspector's investigation, 44% of vaccination points lacked digital temperature controllers. The temperature controllers and coolers are now being replaced.

NanoGroup receives subsidy for oncology medication

From the beginning of 2020, NanoVelos, one of the NanoGroup subsidiaries, will start producing its nanotechnology cancer drug according to Good Manufacturing Practice (GMP), reported Parkiet Gazeta Giełdy (p08) on Thursday.
NanoVelos has received a grant of 6.6 million zlotys (€1.5 million) from the National Centre for Research and Development (NCBiR) for investment in GMP and expects to start clinical trials of its ovary and pancreatic cancer drug next year.



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