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British firm accused of supplying poor-quality drugs to Kyrgyzstan British firm accused of supplying poor-quality drugs to Kyrgyzstan
(about 1 month later)
A parliamentary commission in the remote and impoverished post-Soviet state of Kyrgyzstan is examining claims that a British pharmaceutical company has supplied it with poor-quality drugs.A parliamentary commission in the remote and impoverished post-Soviet state of Kyrgyzstan is examining claims that a British pharmaceutical company has supplied it with poor-quality drugs.
Dialysis patients were switched this year to a cheap new drug, Repretin, which they were assured came from a British pharmaceutical firm. According to local doctors, they began to complain of unpleasant side-effects.Dialysis patients were switched this year to a cheap new drug, Repretin, which they were assured came from a British pharmaceutical firm. According to local doctors, they began to complain of unpleasant side-effects.
Evidence obtained by the Guardian shows that the company, Rotapharm Ltd, is not regulated by any British medical authority, but benefits from loopholes in UK law and the existence of the secretive UK offshore industry.Evidence obtained by the Guardian shows that the company, Rotapharm Ltd, is not regulated by any British medical authority, but benefits from loopholes in UK law and the existence of the secretive UK offshore industry.
It advertises itself on its website as "a British pharmaceutical company created with the aim to improve people's health … established in 2005 as a British generic pharmaceutical company by pharmaceutical professionals". It is said to have its headquarters in Saffron Walden, Essex. The firm has been successfully selling its drugs in a number ofvarious former Soviet republics, including Moldova and Turkmenistan, and in Romania.It advertises itself on its website as "a British pharmaceutical company created with the aim to improve people's health … established in 2005 as a British generic pharmaceutical company by pharmaceutical professionals". It is said to have its headquarters in Saffron Walden, Essex. The firm has been successfully selling its drugs in a number ofvarious former Soviet republics, including Moldova and Turkmenistan, and in Romania.
Rotapharm is, in fact, owned by a Belarussian businessman living in Turkey, has no British employees, was set up offshore in the British Virgin Islands and buys its supply of the dialysis drug Repretin from a manufacturer in Egypt. The company is allowed to advertise itself as British because it maintains a British-registered company, with a small office on UK territory. British regulators are powerless to intervene.Rotapharm is, in fact, owned by a Belarussian businessman living in Turkey, has no British employees, was set up offshore in the British Virgin Islands and buys its supply of the dialysis drug Repretin from a manufacturer in Egypt. The company is allowed to advertise itself as British because it maintains a British-registered company, with a small office on UK territory. British regulators are powerless to intervene.
Dr Dinara Aiypova, a kidney specialist in the Kyrgyz capital, Bishkek, said: "Rotapharm registered here in 2009. It declared itself to be a British company and boasted of European quality."Dr Dinara Aiypova, a kidney specialist in the Kyrgyz capital, Bishkek, said: "Rotapharm registered here in 2009. It declared itself to be a British company and boasted of European quality."
Virtually all dialysis centres switched from a Roche product, NeoRecormon, to Rotapharm's cheaper drug, she said. "After the transfer of patients on dialysis to Repretin, they began to feel bad. This affected blood pressure, decreased haemoglobin, etc. I did some comparisons with other erythropoietins. I saw the difference and reported at a conference."Virtually all dialysis centres switched from a Roche product, NeoRecormon, to Rotapharm's cheaper drug, she said. "After the transfer of patients on dialysis to Repretin, they began to feel bad. This affected blood pressure, decreased haemoglobin, etc. I did some comparisons with other erythropoietins. I saw the difference and reported at a conference."
A campaigning MP in Kyrgyzstan, Shirin Aitmatova, took up the case, but the health ministry continued to buy Repretin through a state tender, she said, "despite the numerous complaints of the patients who are on dialysis that they were experiencing severe side-effects".A campaigning MP in Kyrgyzstan, Shirin Aitmatova, took up the case, but the health ministry continued to buy Repretin through a state tender, she said, "despite the numerous complaints of the patients who are on dialysis that they were experiencing severe side-effects".
Aitmatova has been leading the calls for an investigation into the award of the contract and claims that doctors were given gifts as inducements by the company to prescribe Repretin and other Rotapharm drugs. A parliamentary commission has begun looking into the allegations.Aitmatova has been leading the calls for an investigation into the award of the contract and claims that doctors were given gifts as inducements by the company to prescribe Repretin and other Rotapharm drugs. A parliamentary commission has begun looking into the allegations.
Aiypova says protesters were threatened with legal action by Rotapharm, unless they retracted.Aiypova says protesters were threatened with legal action by Rotapharm, unless they retracted.
Repretin is a version of the generic drug epoetin, known as EPO, which the disgraced cyclist Lance Armstrong recently admitted to taking as a performance enhancer. It is a hormone that boosts the production of red blood cells and is used to help kidney dialysis patients.Repretin is a version of the generic drug epoetin, known as EPO, which the disgraced cyclist Lance Armstrong recently admitted to taking as a performance enhancer. It is a hormone that boosts the production of red blood cells and is used to help kidney dialysis patients.
Rotapharm Ltd and a sister company, World Medicine, owned by Belarussian citizen Raushan Tahiyeu, were set up anonymously in 2005 in the British Virgin Islands. These offshore entities, under the UK-sponsored secrecy regime for which the BVI is notorious, reveal no owners, publish no accounts and pay no taxes.Rotapharm Ltd and a sister company, World Medicine, owned by Belarussian citizen Raushan Tahiyeu, were set up anonymously in 2005 in the British Virgin Islands. These offshore entities, under the UK-sponsored secrecy regime for which the BVI is notorious, reveal no owners, publish no accounts and pay no taxes.
Two parallel firms with identical names were legally registered in the UK at Companies House, originally with concealed ownership and sham nominee directors with addresses in the Caribbean micro-state of St Kitts and Nevis. Later, they were re-registered with Tahiyeu named as owner.Two parallel firms with identical names were legally registered in the UK at Companies House, originally with concealed ownership and sham nominee directors with addresses in the Caribbean micro-state of St Kitts and Nevis. Later, they were re-registered with Tahiyeu named as owner.
The Rotapharm company in the UK has a small office in Essex. It declares small amounts of business in its annual accounts, which are not audited, and pays small sums of British tax.The Rotapharm company in the UK has a small office in Essex. It declares small amounts of business in its annual accounts, which are not audited, and pays small sums of British tax.
But during a visit by the Guardian, this "international headquarters" seemed to have no employees. Behind the locked door and the Rotapharm sign, the only person in residence was the listed company secretary, Zafer Karaman, who lives locally. He refused to answer any questions about Rotapharm.But during a visit by the Guardian, this "international headquarters" seemed to have no employees. Behind the locked door and the Rotapharm sign, the only person in residence was the listed company secretary, Zafer Karaman, who lives locally. He refused to answer any questions about Rotapharm.
Britain's drugs regulator, the MHRA, says it cannot intervene. "If [Repretin] is indeed licensed in the respective eastern European countries it is sold in, then those countries' regulatory bodies have made a decision that the product is acceptable, safe, effective and manufactured to a good standard. As such the MHRA would have no cause to, or precedent to take any action against the company."Britain's drugs regulator, the MHRA, says it cannot intervene. "If [Repretin] is indeed licensed in the respective eastern European countries it is sold in, then those countries' regulatory bodies have made a decision that the product is acceptable, safe, effective and manufactured to a good standard. As such the MHRA would have no cause to, or precedent to take any action against the company."
It was put to Tahiyeu that his pharmaceutical business was not genuinely British. His lawyer said: "You do not have an accurate understanding of our business. Rotapharm is registered and actively operates in the jurisdiction." He otherwise declined to comment on the allegations or to explain the purpose of the BVI offshore entities.It was put to Tahiyeu that his pharmaceutical business was not genuinely British. His lawyer said: "You do not have an accurate understanding of our business. Rotapharm is registered and actively operates in the jurisdiction." He otherwise declined to comment on the allegations or to explain the purpose of the BVI offshore entities.
In its recent series Offshore Secrets the Guardian, in collaboration with the International Consortium of Investigative Journalists in Washington DC, exposed the way British property speculators and Russian businessmen were hiding their activities behind front companies in the BVI, and sham nominee directors. The business department promised an investigation.In its recent series Offshore Secrets the Guardian, in collaboration with the International Consortium of Investigative Journalists in Washington DC, exposed the way British property speculators and Russian businessmen were hiding their activities behind front companies in the BVI, and sham nominee directors. The business department promised an investigation.
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