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01 January 2014

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The President of the PNG National Doctors Association (NDA) has today spoken out in the PNG media against the Borneo Pacific contract.

"Without ISO 9001 (International Standards Organization) accreditation sub standard drugs could be brought into the country and who would be held responsible if patients then die?" Doctor James Naipao was quoted as asking.

“When that happens, the government has murdered its people and the NDA will not stand aside and watch this catastrophe unfold,” said Dr Naipao adamantly.

The association has listed eight demands that it would like the government to meet including that the Central Supply and Tenders Board make public the tendering and scoring process that lead to the government’s awarding of the contract to Borneo Pacific Pharmaceuticals.

Good on Dr Naipao for having the guts to speak out and stand up and be counted. PNG deserves more like him.

Isn't it about time the government took a stand on this issue or risk being held responsible when someone gets ill or dies from sub standard pharmaceuticals?

Just imagine the legal complications and compensation payouts that will ensue. Of course that will just be more government money being used for no good reason

What about the grieving family however? Who will explain why it happened to them?

From discussions on Facebook, I have come to learn that Borneo Pharmaceuticals (BPP) is owned by three members of the Poh family from Malaysia.

One of them, known as Martin Poh, became a PNG citizen. The other Poh siblings, brother and sister, are directors of the company but retain their Malay citizenship.

It has been alleged that Borneo Pharmaceuticals was kicked out of Singapore for providing low quality drugs. They moved to PNG and set up in 1996. Between 1997 and 2007, they grew through National Department of Health contracts.

For a number of years PNG businessman, Igo Baru, listed as a Director of the company, was Director of Medical Supplies at the PNG Department of Health. He took voluntary retrenchment from the Department of Health and became a Director of Borneo Pharmaceuticals in February 2013.

One wonders why Malabag and O'Neill are vigorously defending awarding the contract to Borneo Pharmaceuticals even after Professors Glen Mola and Nakapi Tefuarani spoke against it.

One wonders if Malabag and O’Neill have any understanding of the ISO Standard Compliance which BPP failed to meet.

The ruling that the ISO Standard Compliance was no longer required was done after the original tenders were lodged, and BPP had already failed the original terms of reference.

As one writer said -

“It hurts doesn’t it that we (Papua New Guineans) keep getting the worst possible deals? Well we only have ourselves to blame, we keep allowing people to get away with it and we keep voting in the wrong people into office. We must be the most tolerant people on earth!”

Barbara,

Thanks for the clarification and do thank Graham for us. Apologies for mentioning the wrong vendor for the antivenenes.

Sori to keep on this topic Keith, but Graham is a good contact and he knows where the system is failing PNG. I guess it just needs enough people in PNG to back him to get the necessary changes and a better testing process and for the Dept of Health to understand what needs to be done to ensure the medical kits contain effective medicines etc.

Here are his comments to what Paulus said -
Yes Barbara Short, I'd agree, random surveys are not bad it helps flag issues. The issue is that by now the NDoH is supposed to respond to this random surveys and start running tests using our arrangements with TGA Aussie to verify such claims and build a solid back up profile of such vendors over a period to ensure some consistency in result trends.

We are not like Aussie where the population access medicines through the PBS scheme. Here, the Govt (NDoH) procures for 95% of the population and we have a big leverage to deal with such companies who deliberately bring in cheap sub-standards at our expense and that of our people.

If we find continuous breaches to the trust of doing business with NDoH then we should stop giving orders to them, simple as that. (I don't quite follow this argument. Who else could do it?)

That's why I was saying people need to change first and start working and getting the system running. This 139 medicines in the health center kits is a one off thing, what about all the other medicines, devices, reagents, that constitute the 6000 plus items that the Govt must make available for hospitals, health centers etc.

We need to get the system running. As for quality, its more a systemic process rather than an-in country test which is upon receipt and that is not good we should make sure all NDoH regulatory and procurement process are running well.

For a start I requested for K100,000 for us to send medicines down to Aussie for tests so we could start profiling vendors and their manufacturers while waiting for NDoH to set up a basic testing facility, and received nill funding for the past 2 years including 2014 through the budgets, so another year we'd be in the dark, nobody thinks its important.

As for the Snake antivenon, its by a different vendor and not the same.

Michael and Barbara, Thanks for the technical explanation.

My point is when we take a drug our expectation is that the medicine is still good quality until we reach the expiry date on the bottle.

If some samples are not of good quality what can the doctors or patients think about a bottle of pills they are given when they are sick. Full of confidence that you will be healed or beset with doubts as to whether you are taking a fake substance instead.

We would like our drugs to come from a source from any random sampling will show almost 99% of the time that quality is still maintained. Is that too much to ask for?

My husband, Col, was a spectroscopist at the NSW Department of Agriculture's Biological & Chemical Research Institute for 33 years.

He introduced Atomic Absorption Spectroscopy to analyse plants, waters and soil extracts to the Department in 1963. He was a great friend of Sir Alan Walsh, the discoverer of the technique.

One method of AAS was, apart from the flame, the graphite furnace. Col was able to detect picograms of cadmium by this technique.

This supports the fact that modern chemical analysis techniques such as AAS and HPLC-GC-MS now detect very small concentrations which were previously undetectable. So medical authorities such as the National Health and Medical Research Council here in Australia can set lower limits for toxicity.

So I agree with you Paulus, you cannot pass them off as isolated surveys. The studies that were done on the drug samples showing poor quality were fairly robust and published in reputable journals. So the PNG Department of Health should have taken notice of them.

Paulus, on a techincal note regarding the testing: if it's done using HPLC-GC-MS equipment (Waters if you can afford it, Varian otherwise), then even an inconceivably small trace of crap can be picked out.

In fact there is some problem with how small a sample you should take as being 'representative' because the testing is so fine tuned, accurate and precise, that you could pick-up crap that would otherwise be around anyway.

HPLC was designed for 'isolated surveys'. It's the heart of pharmaceuticals testing.

If that's what was used, apart from maybe tissue work, then we can trust a published report that calls crap by its proper name.

Barbara, I would take issue with some of Graham's comments that you have reproduced.

I quote: "As for quality it would be unjust to label a large well established Chinese manufacturing firm that European ISO firms also source from as producer of substandard / counterfeit medicines, this accusation is serious.

"Isolated surveys for quality cannot be used as a platform to bank on. Quality of products start depreciating the very moment they leave the factory gates and get exacerbated with poor handling and storage conditions along the supply chain, hence points and conditions for sampling are crucial factors that influence determinants in the result of a test."

End of quote.

The studies that were done on the drug samples showing poor quality were fairly robust and published in reputable journals. You cannot pass them off as isolated surveys.

Moreover any random survey must show that there is consistent quality. If random surveys show that there is poor quality than it means patients are not receiving good quality drugs.

Everybody in the health fraternity knows this company and its past reputation. They were known for instance to try peddling Indian antivenenes for snakes that were not in PNG.

This sort of company would be immediately suspect if it tendered for any project.

G'day Francis and Barbara,

Appreciate different points of view however surely it boils down to the old dictum: 'If it ain't broke, don't try and fix it."

Why alter what was actually working well and saving PNG tax money?

Clement Malau has just commented on the SRDDF on Facebook. I was hoping that he would.Here is what he said.

An independent commission of enquiry is needed. A lot of people have suffered and a lot will continue to do so unless the truth is revealed.

I offered to be on the witness stand in an earlier posting. There is so much behind this that needs to be exposed. The Minister might be misinformed so only a commission of enquiry can analyse and come up with the truth. That is if the Commission Oscar not bribed.

Information is education and power. Mrs Barbara has provided us an insight into the technical aspects of the issue sourced from a reputable expert and to water it down is not only unfair but wrong.

I was a pro-Bishop but this information has caused me to reconsider my stance. Thank you Mrs Barbara.

Barbara, in PNG anything and everything that can go wrong will go wrong or has already happened and we're all on the late bus.

Thanks Barbara. I think the really important aspect about this whole matter we have to be very mindful of is not getting snowed with information.

Keeping it simple makes more sense.

No one can say there will be poor quality or substituted pharmaceuticals until there is proof that this has been the case. Clearly there were concerns by those involved and those concerned were voiced by a qualified PNG medical authority.

Clearly the contract will now cost PNG people more than what it cost over the last two years when there were no concerns about the standard, purchase and distribution of these essential medical products. The question then remains to be asked as to why and to whose benefit? This cost increase has not been explained by the PNG government or Minister Malabang and his Secretary Kase.

If Australia has concerns about the accepted tender on such an important matter, surely it shouldn't offer to pay for the operation?

Another interesting comment from Graham Wavimbukie -
China and India are now the worlds leaders in manufacturing Active Pharmaceutical Ingredients (API) which is bought by developed nations such as Aussie by manufacturers such as Pfizer, GSK etc to manufacture brand products such as Panadol, Viagra etc for their domestic markets,ie the active ingredient would have origins from mostly China and India, hence it would mean Aussie Inspectors would have already conducted inspections to many of the manufacturing sites in those countries to verify quality of their imports.

For instance, Kunming from China that supplies finished Arthemeter tablets to PNG also supplies active Arthemeter to Aussie which gets manufactured under an Aussie manufacturer and gets Aussie registrations which hides its actual origins, that's how things work, so I would not want to write off Chinese and Indian Companies who are now striving hard to improve quality with increasing pressure from the rest of the developed world."

In fact, India and China are now the largest manufacturers of generic affordable finished pharmaceutical products (FPP) to the rest of the developing countries, and almost all the HIV, TB, Malaria medicines circulating in the country are evidence to that.

But we also have to note that the South East Asia region leads the world in counterfeits and that is probably what we need to be mindful of and only source from reputable manufacturers from the region.

Footnote - Graham works in the Medicine Lab. at PNG National Dept. of Health. He is setting up a joint control lab. to test medicines. He is a member of the Medicines Technical Evaluation Committee for tenders.

Last October he attended the 6th Global Health Supply Chain Summit in Addis Ababa, Ethiopia. Also last year he spent time being trained at the Australian Therapeutic Goods Administration labs in Symonston ACT.

One wonders how things could go wrong when there are people like Graham involved, who seems to be well trained and knows a lot about the manufacture of medicines worldwide.

Paul you may be able to learn something from what Graham Wavimbukie wrote on the Sepik Region Development Discussion Forum on Facebook this morning -
I guess enough has been said on this subject matter but maybe I could add a little more to shed a different view of the situation.

From my assessment, if we consider the ISO certification, then the initial tender should have been closed and those that did not qualify will not have been entertained from the beginning.

However since the tender was an international competitive bidding (ICB) any company worldwide would have qualified to bid regardless of whether it was ISO certified or whether it was registered here in PNG with the IPA and Pharmacy Board.

The ISO 9001 certifications mentioned and locally demanded IPA and Pharmacy Board licenses are more subjective and this is not very good procurement practice in ICB as in this case which may have led to preference to locally registered companies.

ISO 9001 is for quality management systems which is voluntary in nature and maybe sought by companies that are not involved in primary manufacturing, but more so in secondary processes such as repackaging, labeling, warehousing and distribution and details good practices which lead to an accreditation upon inspection by a certified body.

This therefore will mean, that such certifications do not have an intrinsic value on the products that come out of an ISO certified company that sources from other manufacturers in bulk and sells to its clients.

Value in terms of quality must be verified by individually assessing products and their primary manufacturers.

Having said that, the 139 products that will constitute the kit were assessed objectively by looking at their individual product specifications and their manufacturing origins.

That is the possibly the best way which was undertaken by NDoH rather than focusing on the vendor bidding.

In this case ISO certification would have been more subjective and discriminating and the less vendors that bid the higher the chances of more inflated prices.

In health procurements prices do not hold a high percentage in deciding awards, quality does.

This means out of the 139 products assessed for individual product certificates (CoPP) and current good manufacturing practice (GMP) certificates for the manufacturers, a vendor that scores higher should have been considered rather than awarding subjectively by using ISO or local company registrations and price as deciding factors, that would have be more transparent.

As for quality it would be unjust to label a large well established Chinese manufacturing firm that European ISO firms also source from as producer of substandard/counterfeit medicines, this accusation is serious.

Isolated surveys for quality cannot be used as a platform to bank on. Quality of products start depreciating the very moment they leave the factory gates and get exacerbated with poor handling and storage conditions along the supply chain, hence points and conditions for sampling are crucial factors that influence determinants in the result of a test.

Potentially early this year 2014 the NDoH would start testing some medicines and we may get to generated more information on the validity of such claims.

Having mentioned all these crap, I would reckon that the two biggest mistakes that has led to this end would have been that, if ISO was a weighted factor than the tender should have been closed when called by CSTB and only ISO certified companies entertained.

In addition, the tender should have indicated a "targeted costing" which means a price range based on international averages should have been determined earlier and included as a weighted factor in the tender so we do not have inflated pricing outside of this range being entertained.

I do not work for procurements but can say such bad procurement practices open gaps for bad subjective awards by people who sit on a board and think that buying medicines is like running to a supermarket and collecting anything off the shelves.

When PNG people look at the amount of tax taken out of their pay or the increasing the price of what they buy at the store, maybe they might now directly think about corruption?

Will they or their family receive the proper medicine if they are sick and will it be effective?

When will PNG start thinking about who may have made a ‘financial killing’ at their expense?

This issue is far too important to allow it to be dismissed by those who don’t want everyone to know what is really going on and how PNG people are really being ‘treated’.

From the Social Media .... Ramona speaks again..
Please say NO to Bandaid solutions..just to equip one aid post I wonder what it would cost for logistics and personnel at the expense of Australian taxpayers? We want solutions to fill in every town district, community and city. Pull out our so called medical expects in the private clinics that at hot and pumping out heaps$$ and get them to provide solutions and create partnerships for effective delivery! Healthcare goes beyond the four corners of your clinic! In this case, 7.5 million people are still waiting...

Good onya Ramona!

It is a matter of ruling the line between; corruption in PNG (in a general sense, it is true!) and procurement and competitive bidding on an international market.

However, I have two questions;

Firstly, is Australia the right 'person' who is supposed to tell us that we are corrupt? Secondly; is this mostly Melanesian-owned company (check IPA records) the best on the market, considering standards, quality and again, transparency?

It doesn't matter whether it is a local company or foreign one. The matter here is about saving lives and improving our health indicators and Mr. Malabag and Kase should get this into their heads seriously coz they are dealing with lives, I mean millions of lives.

May the spirits of those who die through the use of bad or low quality drugs haunt the PM, Minister and Secretary until their dying days! A curse on them all!

I agree with Michael Dom. Sadly the developing trend has been to award contracts under suspicious circumstances to dubious service providers and flippantly ignore the concerns of experts, public and independent authorities.

This is however the most sinister of examples as it will directly impact on the health and well being of the ordinary citizens of Papua New Guinea who will be unable to access any other health care but public and will have no choice but to accept drugs delivered by this entity - whether genuine or not.

The fundamental role of any government is to save lives not threaten lives.

Sadly the greater majority of people are very much unaware of this frightening situation and will not raise concern or dissent, their lives apparently not important to the government they innocently believes is serving their interests.

Blood will be on the hands of the NEC (Cabinet) members who did not care for their people enough, especially those who may benefit from this ill advised and sinister NEC submission.

Thanks for that advice Paulus. It's clear that the Health Minister and Secretary Kase would just like the issue to 'go away'.

Clearly the more one looks into the deal the more questions it raises.

Any defence will no doubt eventually descend into: 'We want to manage this process ourselves so outsiders, butt out'.

There appears to be no rationale for expecting that the situation prior to the last two successful years of proper distribution of pharmaceuticals that are guaranteed by international standards will not slip back to where it was previously.

In addition, PNG people will pay more for this medical treatment.

It's hard to understand why some PNG people who are in authority and have the ability to question this situation are not doing so? Is it complicity, ineptness, embarrassment or what?

Lau diba las momo kani. Mi no savi tru ia.

Paul,

The drug testing is going to be done at the School of Medicine laboratories. However the last time I discussed the matter with our scientists which was a few months back they were unhappy because the company they wanted to buy the machines from were not the ones the Health Department chose.

Our scientists had opted for a reputable Australian company to buy the HPLC machines from with attached service contracts etc. However the department rejected that and wanted to buy through a recently set up company whose directors included one or two of my erstwhile colleagues. There was that faintest bit of cloud overhanging the deal.

As I mentioned this was a few months back and I am not sure how that issue was resolved.

With the current staff shortage that we have (the scientists involved in the testing also have heavy teaching loads)I am not sure how the testing will proceed.

More unanswered questions I am afraid.

Prior to the previous two years of successfully arranging for the supply of PNG pharmaceuticals, numerous problems were reported with the purchasing, standard and delivery of these essential supplies.

The Secretary of the Department of Health Pascoe Kase, on 3 January 2014, is now reported as making the following statements about the current questions concerning the new contract for the purchase and distribution of pharmaceuticals:

1. He, Mr Kase, would ensure future monitoring and checking of imported medicines met national standards. His Department has purchased two machines to test the pharmaceuticals provided by Borneo Pacific (BP) under the new contract. Who would be audit this testing is not clear however.

2. According to Mr Kase his Department has allowed the previous supplier and distributor funded by Australian aid money, the International Dispensary Association (IDA), to operate even though he now says it is not registered with the Pharmaceutical Board. Apparently the successful supplier BP is. Incidentally, IDA is a Dutch Company that meets international standards, so it's hardly a case of 'boomerang aid is it?

3. Mr Kase says Australia didn’t provide the K83.52 million – yep! We know that already and why. Australia doesn't want to fund the supply of pharmaceuticals that might be subject to questionable standards. Mr Kase says the PNG government decided to take over the purchase and distribution of pharmaceuticals? Why isn’t clear, although many might guess. Why weren’t these newly raised tender requirements applied in the past? That’s not clear is it?

4. Apparently the BP contract mysteriously resulted in AUS$9 million more being required than the IDA tender. Mr Kase has not made it clear why PNG wouldn't accept the more competitive tenderer that had been suitable over the past two years? What’s changed except an arbitrarily applied technicality?

5. Dr Glen Mola, the Treasurer of the Medical Society of PNG is on record as voicing his concerns that on 6 June 2013 a PNG Health official had maintained the ISO 9001 standard for pharmaceuticals, that had previously to be met, was now no longer required. Exactly why hasn’t been revealed by Mr Kase? Apparently Borneo Pacific doesn’t meet this standard however which hitherto was considered to be essential to protect the medical supplies to PNG people.

6. Dr Mola is quoted as saying: “They have been in PNG for a couple of decades and they (BP) have a reputation. Many of us are concerned because of (their - BP’s) past performance.”

7. The matter has been the subject of a discussion between the Foreign Affairs Ministers of PNG and Australia. Wow! It's not hard to guess what was said?

Rather than excusing his Minister and his department's actions and involvement, Mr Kase appears to have merely added fuel to fire.

So what has the PNG PM, Health Minister or the Auditor General say about spending more and apparently achieving reportedly a good deal less?

What's more to the point however is what do the PNG people say... that is if they are aware that their health and the standard of their medications are on the line and that they now have to find extra taxes to pay for their pharmaceuticals?

Bonnie Bonnie, who did you vote for?

I'd like you to know that our Ministers always fuck things up because they know that their own people will provide the convenient excuses for them.

There is a saying that the Lord helps them that help themselves,
and how true that is about the PNG politicians and their public
servants.

However, what is the price the whole population will have to pay
for O'Neill's government getting into bed with the Chinese.

I'll bet a helluva lot more than Tjandra's rice rorting.

Dear Bonnie Bonnie. It is good to know you are reading comments and so much better that you make the effort to give your thoughts.

May I ask you to reflect on your use of the word "interfere". You appear to use it implying it is a bad thing to do?

I ask you to contemplate the situation that a dear friend of yours is walking (unaware of danger) towards a cliff. Is it wrong of you to "interfere"? What would a "true" friend do in those circumstances?

Mrs Barbara has a point. The point is that aid is being used in disguise to interfere with PNG's development.

If you want to give aid, help us build a road, a new airport or something that will impact the lives of people. The Chinese are not giving aid, but they are building ports, roads and broadband internet.

Australian aid is little substance and too much media publicity. Trukai rice tells its all.

So Mrs Barbara, if you take your aid away, the sky will not fall down. The PNG middle class is well educated enough to look through the smoke screen.
___________

Bonnie Bonnie is a fairly obvious pseudonym. Real name next time, please BB - KJ

It appears to me, from long experience in PNG as a full time worker and assistance given to many local people, that the O'Neill government is no different than those preceding it.

Since Independence, there has been a money grab by politicians and government servants. It has now got to a point where the system is so fully corrupted that even the simple supply of ISO approved drugs has been compromised.

Shame on you O'Neill and Malabag.

The drugs tender was probably the highest tender which likely began with a A$30m bid but ended up as a A$46m bid with someone splitting the additional A$16m between themselves.

The present mob make Somare look like he was playing a game of skittles.
___________

This comment has been edited to remove material that may be defamatory - KJ

I enjoy reading the comments on the PNG Social Media. Some people are trying to imply that Miss Bishop wants the contract changed so that the pharmaceuticals will be bought from an Australian firm rather than from a Chinese firm. They are saying it is a form of boomerang aid.

Here is one comment this morning which shows one person's views on this topic -
AusAid or any type of aid given must first of all be recognised as NOT OUR MONEY! Someone else is digging into their pockets to give it as an assistance. The problem with PNG is its inability to make a good account of such money, spending it wisely so benefits are reaped. Administration failures is PNG problem hence you cant blame a donor if they care too much enough to want you to spend it well and proper.

Dont wail over how that money is managed by them, it isnt your money! What you should be grateful is that someone is helping this country with extra funding, even if they choose where to spend it.

As far as I see, all donors seem to want to spend it on priority areas which PNG Govts fail miserably to fund and maintain sufficiently annually.

Some of you cry boomerang aid as if its your money by some kind of right. Please wake up! If they give it and manage it as well, the point is that the money is doing something here in this country and not being wasted or all sent back as soon as it arrived here.

As long as a school classroom, aid post, some officers goes for further study, medicines are bought, a road is built, a vehicle is purchased or whatever, the aid money is doing something!

Am personally fed up of Papua New Guineans crying boomerang aid always. Traim na understand, the world is a global village and every transaction between a country has boomerang effects.

How can you deny or disregard the practice of it? Nothing is free in this world but if someone can dig into their pockets to help you manage your own life, I think we should just say thank you and shut up while making good use of it!

A vision for PNGS health department should include manufacturing medications on shore with an emphasis on incorporating local herbal remedies. Most vendors of buai do not know what else they can sell that will make money..why not transform the current censoring trends into health awareness champaigns! Once mr n mrs grassroots understand that health is vital to build a prosperous nation we can be certain that generations to follow will build upon such initiatives. All leading experts and researchers should spend quality time Pushing to create such a mindset and make a tough stand on cracking down on all negative trends affecting the nation.
From the Social Media today.

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