VIAGRA NEWS

Source: ArabianBusiness.com

Date: 4-Sep-2008

Author: Joanne Bladd

Counterfeit drugs aren't just a third-world problem. Joanne Bladd reports on the measures the United Arab Emirates is taking to crack down on medication fraud.

As a racket, it is almost as lucrative as narcotics trafficking but the trade in counterfeit drugs receives far less attention. They mirror top-end prescription medications - down to the blister packs and holograms - but typically contain little, if any active ingredients. At best, they are ineffective; at worst, they can be fatal.

Historically, the United Arab Emirates (UAE) has dismissed fake pharmaceuticals as being a third-world dilemma, partly because the worst abuses were confined to Africa and China. But recent high-profile incidents are changing that reticence.

Figures released by the European Union two months ago revealed the UAE to be the third leading provenance for fake medicines seized by border officials. There are also signs that neighbour countries are struggling to stay ahead of the trend.

A study by the European Federation of Pharmaceutical Industries and Associations, held in July, found Egyptians spend approximately US$187m annually on counterfeit drugs; up to 10% of the country's annual total drug spend.

Last year, Lebanon was rocked by the news that some oncology drugs discovered in government hospitals had been found to contain only water.

The UAE's Ministry of Health (MoH) is starting to sit up and take notice, says undersecretary Dr Ali Bin Shakar. "It's a global problem and we aren't immune," he tells Medical Times. "Even the best-regulated markets are breached by counterfeits. We're improving our pharmacovigilance system."

In an early sign of this tougher stance, the ministry's Drug Control Department (DCD) closed down eight pharmacies in the northern emirates in May and June for violating rules. "A few" of these, says Dr Shakur, were linked to fake medications.



Free-trade trials

For the UAE, cracking down on counterfeiters won't be easy. Dubai is particularly attractive as a trade point for traffickers because of its strategic location on the Persian Gulf, between Asia, Europe and Africa.

The UAE is also dotted with free zones; areas designated as trade points and characterised by lax regulation and zero tariffs. These zones are vulnerable because of the large number of goods that pass through them.

Counterfeiters use them to hide shipments and obscure the product's origin. Officials worldwide are alert to packages from China or Africa; a UAE label adds legitimacy.

Last year, UAE custom officials seized a number of counterfeit caches in free zones, including a haul of fake clopidogrel (Plavix) worth $1.36 million. Some of the pills, according to police, contained cement powder.

Plavix manufacturer sanofi-aventis, which runs one of the pharmaceutical industry's most sophisticated anticounterfeiting operations, played a key role in the cache. "The free zones are a blackhole," admits a spokesperson. "As long as you are registered, your imports aren't touched."

Pharmaceutical firms have often shied away from talking about fake drugs for fear of undermining confidence in their brands. But the scale of the counterfeiting, says Dr Ahmed El Hakim, senior manager of Pfizer's Middle East and Africa Group, now outweighs the commercial risk.

Two of Pfizer's bestselling drugs, Lipitor and Viagra, are also among the most counterfeited. "That's the dilemma. I'm talking to you about counterfeit drugs with the purpose of educating physicians, but at the same time we risk scaring patients," he notes.

Another frustration is the typically light sentences handed out to suppliers. The dealers behind the clopidogrel haul at Jebel Ali Free Zone received sentences of between one and seven years.

For narcotic dealers, penalties are far harsher even though the potential profits are similar. Counterfeiters, points out Dr El Hakim, can make a killing. Literally. "We need prison terms and higher fines to reduce this problem," he argues.



Systems errors

For its part, the government sector in in the UAE has taken strict measures to protect its supply line. Medications sold in pharmacies or prescribed by physicians are registered on the ministry General Sale List (GSL), the equivalent of a central clearing house.

However, the registration process for new drugs is lengthy, involving laboratory testing and a full investigation of the manufacturer and distributing agent. Even after approval, drug shipments are scrutinised.

Imports are met at customs, registered, batch numbers matched to the invoices and a certificate of authenticity handed over from the manufacturer. Then, and only then, is the shipment released to registered agents to distribute.

Jennifer Fulmer-Groves, director of pharmacy at Sheikh Khalifa Medical City, Abu Dhabi, believes staying within the GSL is the best way to avoid fake medications. When at all possible, she says, her team of 120 pharmacists use ministry-registered products. "It's the number one thing that we do. We have faith in their processes."

It's a view backed by Mohammed Abuelkhair, head of the drug-control department at the Health Authority Abu Dhabi (HAAD). "We need pharmacies to buy their products only from registered sellers," he told an Abu Dhabi paper.

A flaw, however, is the ministry's less than comprehensive drugs list. The bureaucratic registration method means new drugs can take up to 18 months to get a listing.

Cetuximab (Erbitux), a drug indicated for colorectal cancer and head and neck cancers, was approved by the US Food and Drug Administration in 2006. The ministry took till the first quarter of 2008 to give it the green light. The lead times, say pharmacists, are too long.

"I'm uncomfortable purchasing things not registered with the Ministry of Health...but not having a drug is not an option either," admits Fulmer-Groves. "If it takes six months to get something registered...I'm going to make sure I have that drug in-house."

But stepping outside the procurement channel leaves hospitals vulnerable to fakes. "If we're doing better than third-world countries, it's because we have a system," warns Hashim A. Tarifi, head of pharmacy at Tawam Hospital, Al Ain. The MoH must speed up processes on new drugs.

"We can support the system but these are regulatory issues. They have to come from the government."

For Pfizer's Dr El Hakim, the public sector is less of a concern. The majority of counterfeit trading, he believes, takes place in the UAE's private sector. Any attempts to choke supplies off at the source should start there, he says.

"There is no question about it. Some pharmacists are complicit. They receive these products for very low prices, they make huge profits [and] so if they sell the products then they are aware of what they are doing."



Bad medicine

Medication fraud is easier to hide in the private sector. Money drives trade on both sides of the equation; pharmacies run on profit, while patients are attracted by the cheaper prices of knock-off drugs. Abid Hussain Shakir is a pharmacist based in Jebel Ali. He believes that a portion of the UAE's workforce is priced out of the legitimate drug market.

"Prices are very high, especially when you compare them to Asia," he says. "A large number of low-pay workers are from the subcontinent and they have a different expectation of price. Here, they might not be able to afford medications."

Another driver is the regular drug shortages that plague the private sector. The buying mass of government hospitals means they can stockpile their drugs but private pharmacies are at the mercy of agents.

For Shakir, it's no coincidence that a market shortage of the antibiotic augmentin went hand-in-hand with news that a counterfeit version was being circulated. "If people can't access a drug because it is out of stock or because it is too expensive, they will try other routes," he says.

A draft of the DCD's National Pharmacy Programme in the UAE for 2008-2010 noted that poor returns on medicines have led to illegal sales in many pharmacies.

"It's a real problem if the unavailable drug is the only approved medication for the indication," says Sachin Kolhary, pharmacist at Al Faisal Pharmacy in Dubai. "It's problematic for us and the patient."

Pharmacist Jeena Jalal has first-hand experience of patients searching for an alternative. Jalal, based in Ibn Battuta Mall, says patients have asked for "cheaper medications, so counterfeit".

Most requests tie in to so called lifestyle drugs, she says, "Viagra or muscle-building medications. This is because they can't afford the brand version. We don't tend to see it in relation to chronic therapies."



Counterfeit crackdown

The MoH has tried to clamp down on any under-the-counter trading. Its inspectors carry out spot checks and, only last month, a law was passed to say delivery invoices must display the batch number allocated to the drug shipment at customs. Drug packets also must have the supplier's sticker on.

The ministry hopes these steps will help track any fake medications that infiltrate the system. The pharmacists themselves don't think the regulations are enough. Jalal, who is an Emirati, believes counterfeiting is a symptom of a lax industry.

"Most pharmacists sell antibiotics over the counter," she points out. "That's not permitted but it's widespread. This culture encourages counterfeiting because it's not prescription-led."

Better training for pharmacists and a tougher stance on alternative medicine outlets would cut the problem, she adds. "We need wider checks - not just on controlled medications. But I suppose it is finding the number of inspectors to cover that."

The MoH has promised harsher measures, but it is an uphill battle. There is still no centralised hotline for reporting fake drugs, and no streamlined system for tracking trends.

Counterfeiters, however, are becoming increasingly sophisticated and many are equipped with the same machinery as the original manufacturers. Experts have estimated it takes fakers less than two weeks to replicate new security features such as holograms or tracking tags.

The UAE is exploring new ways to close in on medication fraud but the process is slow. A National Committee for Counterfeiting is being established, to help drive a countrywide action plan.

Panel members will include top customs officials, the three health authorities: Dubai, Abu Dhabi and the MoH, and the police, says Dr Ali Bin Shakur. But plans are still being finalised.

"[The Committee's] job will be to coordinate and cooperate on any cases of counterfeiting," Dr Shakur explains. "We need a better reporting system."

Both HAAD and the MoH have invested in new laboratories to support anti-counterfeiting efforts, but they are expected to open at the earliest in late 2009.

Work is expected to start on the Poison and Drug Information Centre in Abu Dhabi by the end of the year. The centre will be designed to fast-track drug analysis, so any suspect medications can be processed quickly.

The ministry is also opening a high-tech counterpart in Sharjah, at an estimated cost of AED25 million (US$6.8 million). In a bid to better enforce rules on medication use, the centre will be open to all national health authorities and police forces.

Meanwhile, pharmaceutical firms are looking to healthcare professionals to take a front-line role against medication fraud. Pfizer's Dr El Hakim urges doctors to stay alert to warning signs.

"If you suspect a problem, ask the patient to come in with the medication and confirm it with the manufacturer." When advising patients, the rules are simple, he adds. "Go to a certified pharmacist and pay the original price. If it's surprisingly cheap; it's probably counterfeit."