Press review

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Free HPV vaccinations planned for teenagers in Poland from 2021, but availability problems could arise

WARSAW, 17 Jan (APM) - Poland's Ministry of Health (MoH) has announced plans to start a fully reimbursable HPV vaccination programme as a cervical cancer prevention for female teenagers in 2021 and male teenagers from 2026, but even today there are problems with availability of HPV vaccines, reported Dziennik Gazeta Prawna (pA4) on Tuesday.
Poland currently has two suppliers of HPV vaccines, MSD Polska and GlaxoSmithKline (GSK). MSD's vaccines have been unavailable in Poland for weeks, leaving local authorities that have already started their own HPV vaccination programmes without sufficient supplies for the next doses.
MSD says production of the vaccination lasts four to five years and, as global demand has quadrupled, it may be impossible to meet the needs of the MoH's programme on time. Nevertheless, MSD is increasing its production capacity and will spend $16 billion on capital expenditure within five years, of which a substantial proportion will be devoted to the development of vaccines and $1.65 billion will be spent on expanding a current HPV plant and building a new HPV factory over the coming three years.
It will continue to increase the supply of vaccines, which has already doubled in recent years.
GSK, which produces a "less-valent" vaccine than its competitor, has claimed it could meet the MoH's requirements on time, but until it receives further details it cannot guarantee coping with market demand. Its HPV vaccine, Cervarix, is currently available both in pharmacies and healthcare centres for around 370 zlotys per dose (€88). MSD's vaccine, Gardiasil, is unavailable until further notice.
Poland is the only country in the Europe where HPV vaccinations are still not reimbursed.

CBD oil-based medicines must be supervised by doctors

According to Małgorzata Wagner, a Polish pharmacist, cannabidiol-based (CBD) oils are an effective therapy but should not be considered a panacea for all illnesses and should only be administered under the strict supervision of a doctor, reported Rzeczpospolita (pA11) on Tuesday.
CBD oils are used as an ingredient in compounded drugs used for treating severe pain, epilepsy, migraine and autism, but can also be found in dietary supplements.
Not all illnesses require the use of solely CBD but also THC (tetrahydrocannabinols), a psychoactive ingredient which needs to be strictly monitored. The differences in the ingredients of medical cannabis oil are often misunderstood by patients and the use of commonly obtainable cannabis oils, such as Rick Simpson Oil, can lead to overdoses and undesirable effects.
Wagner is warning experiments should not be conducted with cannabis-based dietary supplements and CBD should only be used under a doctor's supervision, as although those medications are effective, there are still no results of long-term studies of their use and it is not known how they affect patients, especially underage patients.

Benefits of e-prescriptions

The e-prescription system has been implemented successfully in Poland and all prescriptions from 8 January are electronic, reported Rzeczpospolita (p3) on Saturday and Puls Biznesu (p2) on Thursday
The recent full introduction of the e-prescription system is a major milestone for Polish healthcare. All information on prescriptions will now be processed electronically, which should improve supervision over treatment, spending and patient safety reported Rzeczpospolita.
According to Deputy Health Mminister Janusz Cieszyński, 70% of all prescriptions in Poland have been electronic since 8 January. The daily number of e-prescriptions and the stability of the system prove the introduction of e-prescriptions has been successful added Puls Biznesu.
The system should also enable flagging malpractice, such as illegal drug exports, which has been a major issue in Poland, resulting in shortages of certain drugs in pharmacies.
They will provide useful information, such as which prescriptions are not dispensed and whether the patients choose less expensive substitutes for their therapies. Finally, the system should help detect potential epidemics based on prescription statistics in individual regions of Poland and will give doctors of various specialisations tools for coordinating treatment of the same patient reported both newspapers.
The e-prescription system is a part of the so-called e-health programme (P1 Programme) co-funded by the European Union, which will collect, analyse and share data. The e-prescription system will be followed by the planned introduction of an electronic referrals programme, the pilot edition of which was being tested from February to September last year and an electronic medical documentation system, the development of which will start in the middle of 2020 reported Puls Biznesu.

Anti-vax movement on the rise in Poland

According to the National Institute of Health (NIH) the number of unvaccinated children in Poland is rising alarmingly and, after fines are imposed, anti-vax parents appeal to the administrative courts, reported Gazeta Wyborcza (p7) on Wednesday and (p.20-21) on Friday.
Poland has seen a sharp increase in vaccination refusals from 3,437 in 2010 to 16,689 in 2015, 30,090 in 2017, 40,342 in 2018 and 44,475 from January to October 2019, making this an average of 6.1 patients aged 0-19 per 1,000.
This trend and the anti-vax concerns are now being used as an opportunity by right-wing parties for a political debate, especially the extremists, reported Gazeta Wyborcza on Wednesday. Meanwhile anti-vax parents are forming groups in the social media and discussing how to adulterate their children's health record books to avoid vaccination obligations, adds Gazeta Wyborcza on Friday.
In the era of fake news and myriads of anti-vax websites, there are only several informative social groups run by practitioners and a factual information portal about vaccines run by the NIH, but this is only a drop in the ocean to stop and revert the anti-vax movement, concludes Gazeta Wyborcza on Friday.

Ruling on parents refusing to vaccinate their children

The administrative court in Warsaw upheld a fine imposed on parents refusing to vaccinate their daughter against infectious diseases, reported Rzeczpospolita (pA13) on Monday.
The Masovian province made the initial decision to impose a 500 zloty (€118) fine on the parents, which was later upheld by the health minister.
The parents claimed that the regulations on obligatory vaccinations are in breach of the European Convention on Human Rights and the Polish Constitution.

Adamed will invest €55 million in growth

Polish pharma and biotech Adamed has received a state subsidy from the Lodz Special Economic Zone programme of the highest tier of 81.1-93 million zlotys (€19-22 million) and a tax exemption, meaning that it should invest 230-310 million zlotys (€54-73 million) in development, reported Puls Biznesu (p8) on Tuesday.
The company already has 2 production plants employing 660 people. In 2018, it spent 30 million zlotys (€7 million) on a pilot plant dedicated to R&D and has announced the opening of another plant by 2020, which will double its production. The company has 500 products in its portfolio.

Celon Pharma settles with GSK

Celon Pharma has announced reaching a settlement with GlaxoSmithKline in a dispute from 2013 on the shape of the inhaler of Salmex, an asthma biosimilar, reported Puls Biznesu (p6) on Tuesday.
Patent rights for GSK's original drug expired in 2011, but the company claimed that Celon Pharma copied some of the inhaler's components in breach of the law. Salmex production was suspended in 2014 and Celon had to change the shape of the inhaler. Furthermore, GSK filed an action in Germany and the UK, which resulted in the prevention of sales of Salmex on several European markets.
Salmex is Celon's flagship product and represents two thirds of its income. It is estimated that, in the nine months of 2019, sales of Salmex reached 45 million zlotys (€10.6 million). The company has been registering the medication on new European markets since 2017, where GSK has tried to revoke its rights to sell it.
The settlement allows Celon Pharma to resume sales of Salmex on European markets where there were legal risks to date and secures the company against these risks in the future. This will allow Celon to actively promote Salmex through its partners from the Glenmark Group in over a dozen European markets, which is expected to significantly boost sales of the product.
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