EMA under fraud review

by emma 7. November 2011 13:08

Pharma Industry News

The EMA is under investigation by the European Anti-Fraud Office (OLAF) over alleged conflicts of interest.

The investigation was raised by Michèle Rivasi, a French Member of the European Parliament, who claims independent oversight by the EMA is impossible due to the majority of its budget coming from pharma.

OLAF told The Independent the investigation opened in July, but “for reasons of judicial secrecy", could not give any further details.

It’s believed the inquiry relates to the Servier’s controversial diabetes drug Mediator. The medication was withdrawn from the European market in 2009, ten years after concerns were first raised the treatment may be responsible for fatal heart problems.

Mediator was on the market for more than three decades and was used as a weight loss drug taken by an estimated 5 million people in France alone, plus countless more in Italy and Spain. It is estimated the drug caused up to 2,000 deaths during its time on the market before it was withdrawn.

The fallout from the scandal saw the French regulator, the Health Products Safety Agency, overhauled and its chief executive resign after an official report found it had “failed in its duties”.

The EMA was formed back in 1995 to provide a collective voice on drug regulation systems in the EU. The Agency has been attempting to its transparency with a series of new working principles and said in October it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after criticism by the Budgetry Control Committee.

A spokesman for the Agency said it was aware of the inquiry but had yet to see any allegations. “We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything,” he said.

Allergic reaction tablet pulled

by emma 20. October 2011 13:29

Pf product news

Krka, d.d., Novo mesto has formally withdrawn its marketing application for Desloratadine Krka (desloratadine) with the EMA.

The generic of Aerius was intended to be used for the relief of symptoms associated with allergic rhinitis and urticaria.

In its official letter, Krka, d.d., Novo mesto said the withdrawal was down to a change in marketing strategy.

At the time of withdrawal, the tablets were awaiting marketing authorisation by the European Commission.

The application for a centralised marketing application was submitted to the EMA in February after Aerius was authorised for use in the EU in January. Prior to its application being pulled, the CHMP issued a positive opinion at its September meeting.

Bill survives Lords votes

by emma 13. October 2011 12:54

Pf NHS News

The Health and Social Care Bill is set to continue its progress after the Government won two key votes in the House of Lords.

Peers voted 330 to 262 against an amendment to refer parts of the Bill to a special select committee and also rejected an amendment to block the legislation altogether.

Ministers say that the votes show the Bill now has wide spread support but the BMA has again called for it to be “withdrawn” or “substantially amended”.

A line by line examination of the Government’s controversial reforms will now begin in the House of Lords on 25 October. Labour has said it will again “fight” the proposals despite the outcome of the votes.

The amendment to block the Bill was put forward by Labour peer and former GP Lord Rea, who argued that it was never a manifesto by either the Conservatives or the Liberal Democrats. It was rejected 354 votes to 220.

Attempts to delay the progress of the Bill, which Lord Howe said my “prove fatal” to the NHS, were tabled by two crossbench peers, Lords Owen and Hennessy. The two called for its referral to a special select committee, which would have allowed witnesses and experts to provide evidence on the proposals after concerns were raised about the responsibility of the health secretary and the role of the NHS’ regulator Monitor in promoting competition.

A spokesman for the DH says decision by Lords “moves us one step closer to delivering a world-class health service that puts patients at its heart and hands more power to health professionals”.

But Andy Burnham, Labour’s recently appointed Shadow Health Secretary, says hearts “sunk around the NHS” when the Bill survived the votes and the Government is “digging in for the long haul” as it faces more opposition.

Doctors’ leader Dr Hamish Meldrum, Chairman of the BMA, says it continues to have concerns about “many areas” of the Bill and says the council will continue to raise its opposition “at every available opportunity”.

Dr Meldrum called for an assurance that patients’ choice of provider of care would not be given priority over the development of integrated services and fair access.

“We also need to see an explicit provision that the Secretary of State will retain ultimate responsibility for the provision of comprehensive health services. In addition, we continue to have significant concerns over the arrangements for public health and education and training and we will be looking to see improvements made in these areas too.”

Read more on this story on Medtech Business.

Lords vote not to delay Health Bill

by emma 13. October 2011 12:44

MB NHS news

The Health and Social Care Bill has cleared another political hurdle: the House of Lords has voted not to refer it to a select committee and not to block the Bill outright.

The Health Bill will now proceed to a normal House of Lords committee stage.

The BMA, who lobbied peers to reject the Bill, have continued to call for the Government’s NHS reform plan to be withdrawn or “substantially amended”.

The amendment calling for referral to a select committee, which would allow witnesses to give evidence, was tabled by cross-bench peers Lords Owen and Hennessy. They argued that aspect of the Bill raised serious constitutional issues – specifically in relation to the roles of the Health Secretary and the regulator, Monitor.

According to Lord Owen, a select committee was necessary to examine “the complexity of this new relationship” between patients, clinicians and the DH. He insisted that the select committee would not prevent the Bill completing its trajectory on schedule.

However, Health Minister Lord Howe denied that the market reforms threatened the integrity of the NHS, and claimed that any delay “could well prove fatal” to the necessary timing – as the changes are already under way.

The Lords voted 330 to 262 against the amendment. They also voted 354 to 220 against an amendment put forward by Labour peer Lord Rea to block the Bill on the grounds that it ran contrary to both Conservative and Liberal Democrat manifesto commitments.

Recently-appointed Shadow Health Secretary Andy Burnham said Labour would continue to oppose the Bill: “It will be debated now over a number of weeks, even months, in the House of Lords – line by line, clause by clause – and Labour will be wanting changes to this bill, substantial and drastic changes to it, so this is far from over.”

The BMA had written to every peer urging them to block the Health Bill as “dangerous”. PM David Cameron responded by claiming the Bill had the broad support of the medical profession, while Health Secretary Andrew Lansley claimed the critics were “politically motivated”. The BMA has rejected both claims.

Following the House of Lords vote, Dr Hamish Meldrum, Chairman of the BMA Council, commented: “The BMA continues to have many areas of concern, including the need for assurance that increasing patients’ choice of provider for specific elements of their care won’t be given priority over the development of integrated services and fair access. We also need to see an explicit provision that the Secretary of State will retain ultimate responsibility for the provision of comprehensive health services.”

Critics of the Health Bill claim that whereas the first version made privatisation of the NHS an overt political aim, the second version retains it as a covert goal and intended consequence of the legislation.

The Government aims for the Health and Social Care Bill to become law by April 2012, a year before the new Clinical Commissioning Groups are due to take charge of NHS budgets.

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