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#InsulinFraud unfolds in Moldova - Ukrainian #Farmak company allegedly involved

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In July 2019, the National Anti-corruption Centre in Moldova instituted criminal proceedings in connection with public procurement of Strim insulin. The issue is the products manufactured by Farmak SAP, one of the largest Ukrainian pharmaceutical companies, the Talk Finance reports

According to Angela Starinschi, the press secretary of the anti-corruption authority, the centre is conducting the investigation in connection with “organization of the public bidding procedures for procurement of medicinal products for those suffering from diabetes”. She has stated that several people have been interrogated, and the documents have been seized with regard to this case. The main suspect named by the Moldovan press is Ivan Antoci, the director of the Centre for Centralized Public Procurement for Health Care. Antoci was dismissed on 26 July.

According to the bidding documents, 20 thousand doses of Strim bio insulin manufactured by Farmak SAP were supplied to Moldova from Ukraine by EsculapFarm.

However, this product does not exist in Ukraine under the given name, and it has not been registered by the European Medicines Agency (EMA). It has been found out that Strim is manufactured in India. According to the investigators, there is no credible evidence of its safety.

In 2017, more than 104 thousand patients suffering from diabetes were registered in Moldova. In autumn 2018, it was resolved to import almost 414 thousand doses of the Ukrainian product following the public bidding procedures.

According to the Moldovan Sanatateinfo.md newspaper, the insulin procurement bidding procedures were non-transparent: the time frames, terms and conditions were changed several times. Moreover, the amount the government was ready to spend for the new insulin was considerably increased: 100 million leus instead of 21.6m leus.

After the investigation had started, State Secretary of the Ministry of Health Boris Gylka claimed that he had been blackmailed to sign the order on procurement of Strim insulin. “The insulin was registered very quickly, which was suspicious. This product has not been studied, there is no data on its effect on the organism, and I cannot understand how it was allowed to take part in the bidding procedures,” he said. Gylka also claimed that several people having their own interest had also been involved.

“It was done during the election campaign when Silvia Radu (Minister of Health of Moldova until June 2019) was de facto released from her office. I had doubted a lot, for about two weeks, before I signed the order. There was a lot of pressure and even threats, including the threat of dismissal,” Gylka admits.

Application of Strim requires an additional injection device. According to Boris Gylka, such devices have not been used in the EU countries for more than five years. Moldova has also refused from application of an additional cartridge for the patients’ convenience. That is why the change of the terms and conditions of the bidding procedures following the registration of Strim that was made on the day when the document was signed looked suspicious. The public official claims that this product is used in Ukraine in 3-4 percent of cases for the people held in prison. In Moldova, the end consumers hardly used the product due to lack of trust in the product.

At the end of July, the Moldovan Committee for Medicinal Products denied registration of the product since it was not known for sure what side effects that product could entail for the people suffering from diabetes. The Ministry of Health and the law enforcement authorities of Moldova suppose it is large- scale fraud.

What is Strim? It is an insulin biosimilar, i.e. the medicinal product of biological origin containing a copy of the original active ingredient. The pharmaceutical product Insulin glargine manufactured by Biocon Limited (India) was registered with the State Register of Medicinal Products of Ukraine in 2017. The marketing authorisation is held by the Ukrainian company Farmak. The same product was registered in Moldova with the commercial name 'Strim'.

The marketing authorisation is also held by Farmak. Why did the Moldovan Committee for Medicinal Products deny registration of the product? According to the instructions given by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), clinical efficacy and side effects of biosimilars shall be studied in accordance with the specific procedure. In fact, the main task of the manufacturer is to prove that the product has sufficiently similar efficacy and safety as well as quality.

While transferring the technology and registering the products before the issue of the marketing authorisation in Moldova, the manufacturer failed to furnish the sufficient evidence of the efficacy and safety of the biosimilar in the registration dossier and used the research materials of the Indian manufacturer without its own research.

The Moldovan journalists suppose that the Indian company Biocon Limited might even be unaware of the fact that their product has caused the multi- million insulin scandal in Moldova far away. It has been supplied to the Moldovan market owing to the close corruption ties of the Ukrainian company Farmak SAP with the Moldovan public officials responsible for supplies of pharmaceutical products into the country.

In Ukraine, Farmak SAP is considered to be one of the pharmaceutical giants. The company is owned by Filia Zhebrivska, who is permanently on the list of the richest people of Ukraine.

According to Deutsche Welle, the Zhebrivski family had business transparency issues in Germany in 2018. The German company pertaining to the pharmaceutical empire of the Zhebrivski had not filed the names of its beneficiary owners into the Transparency Register, which was violation of the anti-tax evasion and money laundering laws.

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Poland may face early election or minority government: Government spokesman

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Poland may face an early general election or the nationalist Law and Justice (PiS) party may govern the country in a minority cabinet, the government spokesman said, after PiS junior coalition partners refused to vote in line with it during Thursday’s parliamentary voting, write Marcin Goclowski and Pawel Florkiewicz.

“Every scenario is possible: both a minority government and early election,” Piotr Muller told private TV broadcaster Polsat News on Friday morning (18 September).

“One can not afford for a situation that the United Right camp is being shaken all the time and the alternative is minority government or early election.”

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EAPM – German Presidency conference a big date, Commission pushes for healthy planet

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Welcome, one and all, to the first European Alliance for Personalised Medicine (EAPM) update of the week, and there is much to look forward to and much to discuss, writes EAPM Executive Director Denis Horgan.

German EU Presidency Conference

EAPM is looking forward very much to its participation in the upcoming German EU Presidency conference on 12 October. Given the present circumstances with COVID-19, the conference will naturally be virtual, but it will be featuring keynote speakers from the world of health and elsewhere – EAPM’s role in the conference has always proved popular in previous years, agenda here, register here.

EAPM on Biomarker Testing

EAPM’s publication, which was launched during ESMO, Bringing Greater Accuracy to Europe’s Health Care Systems: The Unexploited Potential of Biomarker Testing in Oncology, is already winning plaudits, and it can be read here. The report of our series of round tables at ESMO will also be available later this week. 

Concerns raised over accuracy of UK’s 'Operation Moonshot' tests

The scary thing about the UK’s much-publicized problems with Covid-19 testing is not that the system is encountering difficulties — those were inevitable. It’s that the government failed to anticipate them, it has not been transparent about what went wrong or convincing on the question of when the problems will be resolved. Boris Johnson and Health Secretary Matt Hancock have been getting an earful from lawmakers from all parties as stories mounted of a meltdown in the country’s testing system. Many people with COVID-19 symptoms have been instructed to travel hundreds of miles for tests, and those were the lucky ones. 

Hancock has told Parliament on that it would take “weeks” to fix the current problems. Johnson has said only that capacity would be up to 500,000 tests per day by the end of October, compared with capacity of about 375,000 currently. In the meantime, the government will be working out its “prioritization” system for existing testing. 

It is ironic that Johnson has spoken of Operation Moonshot — a bold stretch goal to test 10 million people a day by early 2021 — while now the government is focused on rationing a small fraction of that number of tests. The number of new coronavirus cases seems to be doubling roughly every seven days. Hospital admissions are rising, even if fatalities are still low. In an effort to slow the spread, the government has restricted private gatherings to just six people. Schools in England are already seeing a higher absence rate compared to the same time last year as the merest sniffle or cough sets in motion a chain of reactions that has in some cases resulted in entire year groups being sent home, consequently driving up demand for testing. 

Commission: Healthy planet, healthy people 

Air and noise pollution, the impacts of climate change such as heatwaves, and exposure to dangerous chemicals cause ill health in Europe. Poor quality environments contribute to 13 % (one in every eight) of deaths according to a major assessment on health and environment released today by the European Environment Agency (EEA). Improving the health and well-being of European citizens is more important than ever, with attention currently focused on addressing the COVID-19 pandemic. 

The pandemic provides a stark example of the complex links between the environment, our social systems, and our health. A significant proportion of the burden of disease in Europe continues to be attributed to environmental pollution resulting from human activity, according to the EEA report ‘Healthy environment, healthy lives: how the environment influences health and well-being in Europe.' 

The report, which draws extensively on World Health Organization data on the causes of death and disease, highlights how the quality of Europe's environment plays a key role in determining our health and well-being. It shows how social deprivation, unhealthy behaviours and shifting demographics in Europe influence environmental health, with the most vulnerable hardest hit.

“There is a clear link between the state of the environment and the health of our population. Everyone must understand that by taking care of our planet we are not only saving ecosystems, but also lives, especially the ones who are the most vulnerable. The European Union is devoted to this approach and with the new Biodiversity Strategy, the Circular Economy Action Plan and other forthcoming initiatives we are on the path to build a more resilient and healthier Europe for European citizens and beyond,” said Environment, Oceans and Fisheries Commissioner Virginijus Sinkevičius.

Parliament says common standards essential 

The European Parliament has passed a resolution calling for common definitions for coronavirus cases across member countries. Differences in methodologies in the bloc have made cross-country comparisons more difficult, creating difficulties in interpreting data on the pandemic. The lack of common standards has also meant difficulties in imposing travel policies that depend on data. 

Securing COVID-19 vaccines for EU citizens

The health and industry committees in the European Parliament have hosted a joint meeting about “how to secure access to COVID-19 vaccines for EU citizens: clinical trials, production and distribution challenges”. Clinics are being set up where patients with coronavirus or flu symptoms can go. The idea is that they don’t potentially infect other patients when visiting their doctor, according to the Data Protection Authority. Rapid coronavirus tests and testing in vulnerable nursing homes are also a central part of Germany’s plan for the autumn and winter.

How the EU’s COVAX financing works 

Following the Commission’s announcement on Friday (18 September) about its financing offer for the global COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, the facility now aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world. 

As part of a EU joint engagement (Commission, member states and European financial institutions, notably EIB) to mobilize resources for the Coronavirus Global Response, the Commission intends to mobilize up to €400 million in guarantees to support COVAX and its underlying objectives as part of a Team Europe effort. The detailed terms and conditions for the EU's participation and contribution will be worked out in the coming days and weeks.

Team Europe is ready to put its expertise and resources at work within COVAX to accelerate and scale-up development and manufacturing of a global supply of vaccines for citizens across the world, in poor and rich countries. The EU's participation in COVAX will be complementary to the ongoing EU negotiations with vaccine companies that aim at scaling up manufacturing capacity of vaccine producers, contributing to global efforts.

The European Commission is committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it immediately responded to the WHO's call for action and has raised almost €16 billion since 4 May under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery, and the Commission also published new testing guidelines joining a similar set of indications put out by the ECDC on Friday. 

French regulator approves saliva tests in certain cases

France’s health technology assessment body has said that it’s acceptable to use saliva-based coronavirus tests in the place of nasal swabs in certain cases. These tests are less sensitive than nasal swabs and should not be used for asymptomatic individuals, the Haute Autorité de Santé said. However, saliva tests should be considered for individuals for whom nasopharyngeal swabs are not ideal, such as for children, the elderly, and those who have any psychiatric disorders.

And that is everything for the start of the week – don’t forget to register for EAPM at the German EU Presidency conference on 12 October, agenda here, register hereEnjoy your week and stay safe.

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Inside Poland’s 'LGBT-free zones'

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In Poland, dozens of small towns have declared themselves free of "LGBT ideology". Politicians' hostility to gay rights has become a flashpoint, pitting the religious right against more liberal-minded Poles. And gay people living in these areas are faced with a choice: emigrate, keep their heads down - or fight back, writes Lucy Ash.
Magazine editor Tomasz Sakiewicz shows me into his Warsaw office. To my surprise, he takes my hand - which I've just rubbed with the regulation disinfectant gel - and kisses it like an 18th-Century Polish nobleman.
Then he passes me a sticker that came free with his magazine, the right-wing weekly Gazeta Polska. It shows a rainbow flag with a black cross through it. "We gave out 70,000 of these," says Sakiewicz. "And people congratulated us because we Poles love freedom."
Anti-LGBT sticker produced by Gazeta Polska
Some 100 towns and regions across Poland, nearly a third of the country, have passed resolutions declaring themselves free of "LGBT ideology". These resolutions are essentially symbolic and unenforceable but they have provided fresh ammunition in Poland's increasingly bitter culture war.
Sakiewicz tells me people should be able to have sex with whoever they choose and boasts that in some respects, Poland is progressive. It decriminalised homosexuality in 1932, decades before most European countries.
But he is against what he describes as "aggressive ideology promoting homosexuality". The struggle for gay rights is a foreign concept imported from the US and Western Europe, he adds, and it threatens the traditional heterosexual Polish family.
Now in his 50s, Sakiewicz grew up in a Poland controlled by the Soviet Union when the government told people how to think, rejected Church influence and tolerated no dissent. Bizarrely, he now accuses LGBT campaigners of behaving in the same way.
Tomasz Sakiewicz
Tomasz Sakiewicz
"Communists used to wave the red flag and told people they were fighting for the poor, for the workers, for the peasants," he says. "Now these activists hold up the rainbow flag and say they are fighting for sexual minorities. It was not true and it is not true. And since we lived through communist times we have a duty to tell others how dangerous such ideas can be."
However far-fetched Sakiewicz's ideas may seem, they are echoed by senior politicians and figures in Poland's influential Catholic Church. In a campaign speech when he stood for re-election, President Andrzej Duda called the promotion of LGBT rights an ideology "even more destructive" than communism. The Archbishop of Krakow recently warned of a neo-Marxist "rainbow plague".
Presentational grey line

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Presentational grey line
With state-sanctioned homophobia and a largely hostile media, Polish gay people risk being pushed back into the closet, especially in small towns.
Swidnik, a couple of hours south-east of Warsaw, was the first municipality to adopt a resolution against "LGBT ideology".
Bart Staszewski
Bart Staszewski in Swidnik
When I arrive on a Saturday morning, half a dozen gay activists are in the main square handing out leaflets, "love is love" stickers and iced doughnuts with multi-coloured sprinkles. Their spokesman, Bart Staszewski, has organised what he called a queer tour of Poland's east to show people that gay people are "normal citizens".
He adds: "We are the rainbow myth-busters. We are not aggressive. Our balloons are not provocative, our flags are not provocative. Our doughnuts are not provocative!"
Donuts handed out by LGBT rights activists
But on the other side of the street, there is a group of about 30 young men shouting themselves hoarse. "Swidnik free of rainbow propaganda," they yell, trying to drown out the sound of the breezy pop music coming from the speakers of the gay rights activists.
One man, with a shaved head, tells me he doesn't like the LGBT group's message. "They don't want to fit into our society," he says. "And we don't want them in this town."
"They are weakening the nation," says another. "And that's the goal of Poland's enemies. War's no longer about tanks and missiles. You destroy a country by making chaos. And that's what these gays are trying to do."
Anti-LGBT protesters
Between the two groups, there's a long line of riot police all wearing helmets and bullet proof vests and sweating in the hot sun.
"To be honest, I am glad the police are here", says Staszewski. "We feel much safer." He adds that many gay, lesbian, bisexual and transgender Poles have recently emigrated to escape persecution.
In Tuchow, a town of 6,500 people founded in medieval times, which has also declared itself free of "LGBT ideology", I meet a gay teenager in a local park. Filip, not his real name, moved to the town from a more liberal-minded big city. His parents have no problem with his sexuality. And nor has Filip ever feared for his safety in Tuchow. Still, that doesn't mean it is easy to be gay in this part of Poland, 100km east of Krakow.
"Once, when my boyfriend and I were holding hands", he says, "we heard a few people shouting names at us." Gay people in Tuchow, he adds, can only live in peace by staying "invisible". If he hasn't suffered from any bad experiences, it is because he is "a bit of a nerd" who spends much of his time playing video games in front of his computer.
"I just read a post on Twitter that one of the gay activists has said that the time for peaceful struggle is over", says Mateusz Marzoch protesting outside Warsaw's university. "Well, they need to know that if they are taking the gloves off, our side won't run off to hide. We'll meet them head-on. And it's going to hurt."

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