Press review

 - 

Polish health officials slam MPs for voting in favour of an anti-vaccination bill

WARSAW, 12 Oct (APM) - Healthcare agencies have criticised a Polish parliamentary vote in favour of advancing the controversial anti-vaccination bill, which seeks to scrap compulsory vaccination.
The news was reported by several publications on Friday- including Rzeczpospolita (pA12), Dziennik Gazeta Prawna (pA1-A3) on Monday and (pA4-A5) on Tuesday, Gazeta Wyborcza (p1) on Wednesday, Gazeta Wyborcza (p16) on Thursday and Rzeczpospolita (pA17) - and came after Poland's lower house of parliament, the Sejm, voted in favour of the bill, which supports ad hoc as opposed to non-optional preventative vaccination.
The head of Warsaw’s regional medical chamber had already criticised the parliamentarians - who are simultaneously healthcare professionals - for their vote, Rzeczpospolita wrote on Monday.
Passing the bill would adversely affect the immunity of the whole population, Rzeczpospolita cited the council of the medical chamber as saying on Monday, adding that universal vaccination always anticipates diseases and cannot be substituted by ad hoc vaccinations.
On Tuesday, Dziennik Gazeta Prawna interviewed Poland's Chief Sanitary Inspector, Jaroslaw Pinkas, who insisted that advancing the anti-vaccination bill is a failure on the part of the healthcare environment and evidence-based knowledge.
He stressed that it is now important to present rational arguments for vaccination as a disease preventative, but does not expect to convince the activists, who he claims are pursuing an ideology and twisting facts. Pinkas even accused doctors of being bribed by pharmas.
Lukasz Jankowski, the head of Warsaw’s medical chamber, is now calling on Poland's health minister to reprimand the healthcare professionals who backed the bill.
Dziennik Gazeta Prawna added on Tuesday that the doctors who voted in parliament in favour of processing the bill further not only breached the code of medical ethics, but also misled the public. According to the Supreme Medical Council, a doctor’s role is not only to prevent diseases, but to act in accordance with current medical knowledge and not promote anti-health attitudes. The head of the Council, Andrzej Matyja, said these doctors should be assessed by the courts of the regional medical chambers.
Meanwhile, the pro-vaccination lobby has started a petition to introduce a law preventing unvaccinated children from attending nursery schools and crèches reported Gazeta Wyborcza on Wednesday. The lobby believes the only solution now is to change the law nationally to force parents to vaccinate their children.
Gazeta Wyborcza explained on Thursday that anti-vaccination lobbies started with Dr Andrew Wakefield’s arguments about the connection between the MMR vaccine and autism. Dr Wakefield was working on contract to a lawyer representing parents demanding compensation from pharma companies at the time.
Although Wakefield was relieved of his ability to practice the profession of doctor, followers appeared and promoted anti-vaccination campaigns. Still, statistics suggest that vaccines stop epidemics and deaths from various diseases, while adverse effects are few and far between.
The STOP NOP anti-vaccination organisation has additionally just embarked on a further initiative of lobbying for greater freedom of patients to decide on their therapies. The courts would then need to determine who is responsible for any adverse reactions or health problems arising from such decisions.
Deputy health minister Marcin Czech added that the current regulations do not require patients to undergo therapies with which they are not satisfied and doctors have to inform patients about all potential adverse effects.

Most Poles believe vaccinations should be obligatory

Despite lobbies in favour of making vaccination optional, 77% of Poles support obligatory vaccinations, while only 18% believe parents should have the freedom of choice, Rzeczpospolita (p1 & p5) reported on Tuesday, citing an IBRiS opinion poll.
Justyna Socha from the STOP-NOP anti-vaccination organisation argued that, if all vaccines were effective and safe, the state would not have to force parents to vaccinate their children by imposing fines.
Jan Bondar from the Chief Sanitary Inspectorate said over 90% of Poles vaccinate their children, while many of those claiming they should be voluntary do so not because they are unwilling to have their children vaccinated, but because they believe the freedom of choice is important.
He added that, of 30,000 children who have not had all the obligatory vaccinations, only 30% are being raised by anti-vaccination supporters.

Establishment of the Polish Medical Research Agency could take away treatment funding

The Polish Ministry of Health’s (MoH) plan to establish the Medical Research Agency (ABM) is giving rise to concern about its source of financing, responsibilities and management pay, Gazeta Wyborcza (p4) reported on Monday.
The idea is that the ABM would be primarily responsible for running independent, non-commercial clinical trials of innovative particles and medical devices with a target budget of 1 billion zlotys (€232 million) financed by the state and the National Health Fund (NHF).
The NHF would be required to provide 0.3% of its total budget to the agency every January, starting in 2019, which would currently be 240 million zlotys (€55.7 million).
However, the proposed funding is causing some concern among experts. While the MoH claims this should not seriously affect the NHF’s budget, as the money will still be used on actual treatment, former deputy health minister Anna Knysok says this argument is highly inaccurate and taking away such a large amount will restrict access to treatment for many patients.
Meanwhile, the salaries of the ABM’s senior managers could be potentially higher than those running other state institutions. The upper limit of annual bonuses is not specified and the selection criteria are relatively low, with the health minister being responsible for the final decision.
Some experts also say that certain ABM responsibilities will overlap with other state institutions and are concerned that, with a limited budget, it will not be able to develop new drugs. Furthermore, it will not contribute to the testing of already approved drugs, as hospitals are excluded from the list of entities that can take part in the tenders.

Polish battle against illegal drug exports continues

Polish officials are working on additional regulations to curb illegal drug exports, an issue which has led to shortages for over 200 medicines in the country, Dziennik Gazeta Prawna (pB6) reported on Monday.
Although a number of laws have been passed over the past five years to curb the illegal reverse supply chains, over 200 medicinal products are still experiencing shortages in pharmacies due to illegal exports, the report notes.
The new regulations should see police and border guard support for pharmaceutical inspectors during audits, which have often been obstructed by business owners, it adds. Authorities also aim to improve information flow between these authorities through the new regulation.
Besides facing issued from businesses, Dziennik Gazeta Prawna noted that pharmaceutical inspectors in Poland are often restricted when they discover other illegal activities such as drug counterfeiting, unsanctioned production and distribution, drug falsification and tax offences, since evidence is frequently destroyed by the time the inspectors receive assistance, making it difficult to secure.
The existing regulations still prevent forced entry into locked premises during audits and the pharmaceutical inspectors hope police will be able to help with this situation. Still, despite changes in the incoming regulations, this idea would still require further changes in the law.

Prescription drugs are being freely sold in the internet

Meanwhile, tens of thousands of prescription drugs are being sold in China by two internet stores, namely Alibaba and JD.com without any restrictions, Parkiet (p20) added on Saturday.
Internet sales of prescription drugs are illegal, but the sellers classify the transactions as non-internet sales because they collect payment on delivery. Most sellers of these drugs are pharmacies, which buy from pharmas or distributors.

Harsher penalties for the incorrect storage of vaccines

According to the new regulation being prepared by the Ministry of Justice, managers of hospitals or health centres, doctors, nurses, pharmacy owners and pharmacists could face up to five years’ imprisonment for the incorrect storage of vaccines, reported Dziennik Gazeta Prawna (pA1 and pB7) on Tuesday and on Friday (pA6).
The regulations are the effect of malpractice revealed in February 2018 regarding the administration of vaccines to 385 patients, even though these vaccines had been planned for disposal because of incorrect storage conditions.
This issue applied to hepatitis B, meningococci, pneumococci, tetanus, tuberculosis, rabies, measles, Euvax B, Engerix B, Bexsero, Clodivac, Boostrix, Typhim and Verorab vaccines.
Although nobody suffered injury at the time, this sanction is supposed to prevent the recurrence of such situations.
Deputy justice minister Marcin Warchol said the MoJ intends to prevent situations where vaccines are stored incorrectly on purpose, but not to penalise anyone as a result of breakdowns of refrigerators, as long as the vaccines are later disposed of. He claims the doctor’s decision to administer the incorrectly stored vaccines because he considered them of appropriate quality should be penalised, as it was in conflict with the pharmaceutical inspector’s decision.
Meanwhile, Marek Tomkow, vice president of the Supreme Pharmaceutical Council said it should not be the mere storage of drugs that should be penalised but their administration to patients after having been stored incorrectly. He gave the example of drugs that are intended for disposal, which are waiting to be disposed of and are not intended to be administered to patients. According to the draft regulations, a doctor could be sentenced to imprisonment for this if the regulations are followed to the letter, according to the paper on Tuesday.
Warchol also stated that the change in the regulations will mean that, in the case of extreme weather events and power cuts resulting in vaccines no longer being usable, health centres and hospitals will no longer have to cover the cost of disposal and restocking on their own, which may have been a reason for some of them disregarding the official guidelines in the past.
The officials are also considering additional requirements, such as obligatory electronic temperature sensors registering cooling conditions in vaccination centres to avoid potential oversights and misuse, the paper wrote on Friday.
However, experts say making the penalties more severe does not solve all the problems, such as the lack of clear guidelines for storing vaccines and monitoring in outpatient clinics, using drugs brought in by patients and training medical staff reported, it added.
rw/nm

[NM7PGHBH6]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to our last stories

Request a trial to assess coverage that includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.