Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, August 24, 2015

NHS in England: Medical device "hospitality" may land doctors in jail.

Jeremy Hunt: NHS bosses face jail over links to drug firms


By Tim Ross,   @TimRossDT  Senior Political Correspondent
10:00PM BST 22 Aug 2015
Senior medical staff will be forced to declare all gifts and hospitality they receive from drug companies or face the sack and the threat of jail.
In a major crackdown on corruption in the NHS, all hospitals and GP groups will be required to keep a register of hospitality and gifts from pharmaceutical firms to health service staff.
Jeremy Hunt, the Health Secretary, says he was forced to act after the Telegraph uncovered “disturbing” evidence of senior NHS managers being paid thousands of pounds and taken on expensive trips by firms lobbying to get their drugs used.
The transparency, or “Sunshine rule”, will be mandatory from next year and any member of staff who fails to declare full details of perks they receive will face disciplinary action.
If they are found guilty of wrongdoing – such as for accepting gifts or luxury foreign trips in exchange for influencing the NHS to buy particular products – they could be prosecuted under the Bribery Act, which can result in unlimited fines and up to 10 years in jail.
The NHS in England buys £7 billion of drugs each year, meaning that the taxpayer-funded health service is a lucrative business opportunity for drug companies and manufacturers of medical devices and equipment.
However, a report from Lord Carter earlier this year found huge variations in the amounts different hospitals pay for particular items –such as latex gloves or syringes - and in the cost and effectiveness of certain treatments, including varieties of replacement hips. This prompted concerns that billions of pounds was being wasted on inefficient systems.
Some NHS managers charged up to £15,000 to organise “advisory board” meetings for drugs companies – often in luxury hotels around the world, the investigation found.
Writing in The Telegraph today, Mr Hunt says it is "shocking" that thousands of sales reps are targeting the NHS. He says he has seen evidence that 65 reps were on site at one hospital at the same time.
Mr Hunt pays tribute to the Telegraph investigation for shedding further light onto the practice and uncovering “disturbing evidence of NHS staff and professionals, alleged to have received payment or hospitality from pharmaceutical firms and medical device manufacturers to influence NHS purchasing decisions.”
A government report by Lord Carter found some hospitals paid 2p for one particular medicine, while one hospital spent £150 on a slightly different variant.
“Even worse, the Telegraph’s investigation suggested that some NHS staff and professionals making these decisions may have been influenced by extravagant hospitality," Mr Hunt says. "It’s hard not to conclude that some sales reps have ben ripping the NHS off, and diverting taxpayers’ money away from patient care.”
The minister says he does not want to stop “sensible” collaboration between private firms and the health service “but we must not tolerate abuse”. Only a tiny minority of staff have been accused of wrongdoing “and the overwhelming majority would be horrified” that drugs and equipment were being bought for any reasons other than that they were best for patients and taxpayers, Mr Hunt says.
The Sunshine rule is based on a similar initiative that was introduced in 2013 in America. The Department of Health said corrupt health staff would face disciplinary action, including the sack, and potentially prosecution which could result in fines or even jail.
The Human Medical Regulations 2012 ban the offering of gifts in connection with the promotion of medicines to anyone who is qualified to supply or prescribe medicines. Convictions under these laws can result in a two year jail term. Acts of bribery or fraud are covered by the Bribery Act 2010 and the Fraud Act 2006. Convictions under the Bribery Act can lead to up to 10 years imprisonment and an unlimited fine.

The Sunshine rule registers will be maintained by NHS hospital trusts, and Clinical Commissioning Groups, which oversee GP services and are responsible for purchasing drugs and equipment.
http://www.telegraph.co.uk/news/health/11818749/Jeremy-Hunt-NHS-bosses-face-jail-over-links-to-drug-firms.html

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