The Health Sciences Authority (HSA) classify medical devices varying in complexity from simple products like tongue depressors, surgical sutures and contact lenses to more complex devices such as implantable defibrillators, prosthetic heart valves and diagnostic imaging systems. Dr Raymond Chua, deputy director of the HSA health products regulation group, talked of the need "to instill the sense of safety in doctors". From the perspective of the layman, all we see are the questionable charges implemented to evaluate "medical devices" like wheelchairs, bandages, and condoms. Like the $6,000 and 11 months for the "full evaluation" of a prophylactic. Are they planning to recall Annabel Chong for an encore performance of her marathon session?
What local doctors are really upset about is why the approval of the FDA or the EU is not enough. "The FDA is a US monstrosity that has thousands of people working full-time. Why does HSA want to re-do what the FDA has done?" asked Dr Huang, an ear, nose and throat specialist. One suspects the answer is right there in the good doctor's question. The Health Ministry probably wants to create another monstrosity in the civil service, staffing it with thousands of people (and expensive permanent secretaries), and boosting the cost of living even higher than it already is. We have seen how Vehicle Inspection Centers have been set up to swell up the government coffers. And made thousands of motorists poorer. MAS claims to be "very concerned" about the persistent inflation, hovering around 5%. It's strong Singapore dollar strategy won't be of any help if the inflationary pressure is generated internally.
On the medical supply side, many reputable manufacturers may decide to skip the Singapore market rather than put up with the bureaucratic crap. But doctors who run the risk of importing an item not registered with HSA face a potential fine of up to $50,000 and/or a jail term of 2 years. At the end of the day, the patient suffers - for want of a better catheter or anaesthetic. Eye specialist Dr Tan suggests HSA should follow the example of Japan, where doctors can bring in anything - instruments, drugs, etc - if they assume personal responsibility for their use. If you can't trust your doctor, who can you trust? HSA is not budging, they are only prepared to "review its charges." It was always about the money, not affordable health care for the citizens.
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Vote Opposition in GE 2016.
ReplyDeleteTell your PAP MP that you the voter is keeping an eye on him.
And whether he supports the Minister-Millionaire for Health on this dumb initiative to re-invent the wheel.
For HSA to initiate such a shift, they must first prove to consumers that current equipment used is not safe for patients. Otherwise, we have no choice but to think it is another money making scheme. We Singaporeans are paying too much for everything - be it transport, school, utility or medical. Does the government know that our salaries are actually decreasing in real term? Instead of reaching the Swiss Standard, we may soon match those in developing countries.
ReplyDeleteAdded procedure. Financial burden for all. HSA also taking on added risk for assessing all these devices. Would it take responsibility for any problems that cropped up later given that the device has passed its inspection? If not, why the added bureaucracy and costs? If the intention is to instill a safety awarenss and sense of responsibility in doctors, would it not be simpler to require the doctor make a prfessional judgement to take on the responsibility of using a device that is not cleared in Singapore (though it may or may not have already been cleared by other health authorities)?
ReplyDeleteBefore a company can import a medical device, it must have a HSA importer licence. If it wants to distribute the device, it also needs a separate distributor licence. In order to apply for these licences, the company must first be audited. Before you can talk about product registration, thousands of dollars will have to be spent on just the licences and audit. To ensure income remains steady for the HSA and the audit firms, licences have to be renewed (fees apply) and audit done annually.
ReplyDeleteThe double whammy comes when medical devices, even some low risk devices, will have to be registered one by one. Registration is a time-consuming process. Not to mention, the high registration and evaluation fees for all moderate to high risk medical devices. Imagine you have hundreds of moderate to high risk products in your inventory, that would cost hundreds of thousands to millions to have everything registered so that your business can continue uninterrupted.
Will you ever trust any health officials claiming they are working very hard to keep health costs down? Perhaps you should, because it could have been worse if they want it to (by making the licence and registration fees more expensive). Meanwhile, patients will have to continue to pick up the bill for the overhead.
Creating barrier of entry to create a protected market
DeleteThis government is useless plus hopeless. Inventing ways and means to squeeze money out of the people and then squandering all these away in those loss-making overseas investments.
ReplyDeleteWho says there is meritocracy in Singapore?
Tattler.
ReplyDeleteDo some research on the property market especially the sub sector known as Medical Suites.
You would be surprised that sometimes the capital gain from there can easily outstrip the earnings from the "practice" side.
They are purportedly building a new Garden by the Bay, and charging residents a "lower fee" compared to foreign tourists. So, if this is not fleecing people regardless of their status, then I guess it is something we must be thankful for eh????
ReplyDeleteWith rising hospital bills and now added medical processes, all I can say is that no matter how much an average worker saves, he is likely to be a bankrupt if he fall ill with a major sickness. No joy even he has medisave or medicare. It would be better off for him to die, cheaper after minus all funeral expenses. What happen to this society? Are we setting up our hospitals to attract rich foreigners or to serve the people?
ReplyDeleteThe real problem is, without universal healthcare(and with a strong aversion to welfare of any sort, even if it is qualifiable), I believe that the unemployed and poorer ones in Singapore are already disadvantaged.
Deleteall these guys should be sent to IMH to be checked out.
ReplyDeletemeanwhile, i guess i cant put in my stents anytime soon. and the bill will have quadrupled
when i can. hmmm, a bypass will be cheaper then.
Perhaps off topic but related. Have a look at medical tourism in SG so far. These stats were variously reported
ReplyDeleteParkway 38% increase from Indian patients in 2011
Raffles 20-50% increase from Asean patients in 2011
SMG 25% are foreign patients from China & India. They flew here to give birth
Asian Center 90% are foreign patients who come here for transplant
Brokers - they make 10-15% for such arrangements
What do we think of opening our floodgate (once again, on top of our education/transport/workplace/housing) to promote these medical tourism? Are we not concern that this will diminish local access to cheap and affordable healthcare? How many times have we seen now a shortage of hospital beds? And our long wait time? And how all these are driving up medical costs and delaying wait time for locals?
Do we need to see a repeat in housing prices driven up by foreign purchase to happen in our medical provisions? These are the hard questions to ask. I'm sure there are money to be made from all these instruments but once again, at whose "added expense"? This is the same Minister who was previously in charge of the Immigration flagrantly. How do we know singaporean patients are not going to be worse off both in terms of access & costs?
The new target for Singapore's medical tourism in 2012 is - YES, 1 million f**king tourists!! Some people ought to ask those ask questions on the would be impact before it's too late again.
http://www.chinapost.com.tw/business/asia/singapore/2012/04/10/337391/p1/Medical-tourists.htm
http://www.kpmg.com/CH/en/Library/Articles-Publications/Documents/Sectors/pub-20120207-issues-monitor-healthcare-medical-tourism-en.pdf
ReplyDeletei wonder what would happen if the entire medical community Refused to have these devices checked? would they arrest them all? the monitoring is more severe than for food!
ReplyDeleteWTF is wrong with our PAP govt leaders ? People already squeezed left & right and yet they come up with so many crazy ideas to make things end up more & more expensive as if our medical costs is already not high enough?
ReplyDeleteGas price goes down but our electricity rate goes up ! Public flats costs >$S500K, small cars costing>S$120K+, Taxi companies bidding >$100K+ for COEs, hawker lots traded @ S$200~300K, etc.
When is all these going to stop, I mean our greedy leaders ?
Don't forget the salt. Resale Maisonette in Bishan clocked $900k!!!
DeleteDon't forget the vinegar too. HDB shop bidded at $32,800/mth for clinic in punggol !!! How much you think the doctors are going to charge to break-even?
DeleteSingaporeans deserve the Government they voted in.
ReplyDeleteThank you fellow Singaporeans.
"to instill the sense of safety in doctors"
ReplyDeleteDidn't NUS medical faculty already instill in our "future doctors" about safety before they even graduate? I didnt know our locally trained doctors are that reckless in their profession! Oh yes. they added 6 zeros behind a $23 consultation.
HSA can do risk assessment better than America's FDA meh?
ReplyDeleteHSA and Singapore so good meh?
You mean HSA so good they can double check on America's FDA?
Un..fuXXking ..believable.
Just another attempt to make money from the Singaporean public.
This is the same HSA that not too long ago, made some mistakes on DNA testing that affected 412 criminal cases where 87 needed to be retested. It took them 10mths before they realized the errors.
DeleteYou'd be surprise that when it comes to medical device registration, how "lax" FDA can be. In the same article quoted, there was a massive recall of knee replacements by the FDA simply because their proces to register these products weren't stringent enough. When there are known weaknesses in the FDA's registration process for medical devices, would you therefore trust a foregin authority to make that decision on Singapore's behalf.
DeleteThis licensing system is just a way to protect the big companies who have the sales volume to justify the costs. Can CCS investigate the impact of such stifling rules on entrepreneurs?
ReplyDeleteUnnecessary and costly licensing system for its own sake is a waste of money and just a protectionist tool of the big companies. Look at tobacco importer licensing. Because of it, a few MNC tobacco companies are making big profits.
Trying to outsmart FDA is a stupid move. FDA has one the most strigent testing procedures on earth. Here we are a small fart who rather ignore result of FDA testing but do it once again in our small labs managed by not so clever technicians.
ReplyDeleteI think you need to check FDA's licensing guidelines for medical devices. They may be stricter when it comes to medications, but medical devices? that's really debatable.
DeleteFrom today's paper: An importer asked HSA CEO Dr John Lim if a subsequent importer of a previously approved item must also pay for the same device to be evaluated. His answer? This was something the HSA "had not thought about before but would look into now".
ReplyDelete*palmface*
What else have these clowns "not thought about before"?
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