Ministry Plans Ban on Re-export of Medicines

The UAE is taking measures to combat counterfeit drugs. One of those measures is to ban re-exportation of medication.

An article published this week in Khaleej Times quotes prominent industry and regulatory leaders on the scope of the counterfeit drug trade in the Middle East, the challenges, and current initiatives to combat it.

Below are some key fact listed in the article:

The scope of the counterfeit drug trade and seizures in the Middle East

• Nearly one per cent of the fake medicines detected in the European Union comes from the UAE, said Dr Amin Al Amiri, CEO, Medical Practice and License at the UAE Health Ministry


• During the first five months of 2008, Dubai Customs seized and destroyed 293 tonnes of counterfeit medical products.


• During 2006-2008, the UAE ranked sixth in the region with 36 numbers of raids in which counterfeit medicines were seized. Israel topped the list of 10 countries with 162 raids. “Four other incidents in the UAE discovered goods that were being diverted to another country,” said Ashley How, regional director for Pharmaceutical Security Institute.


• In 2008, $3.1 million worth of Pfizer counterfeit drugs were seized in the region. “It is not only expensive drugs that are duplicated but even common ones such as Ponstan,” said Steve Allen, Pfizer’s senior director for 
Global Security. “This is because people would prefer buying a drug from a known company rather than an unknown,” he said, adding that 30 of the company’s well known drugs including Viagra, Ponstan, Xanax and weight loss drug Lipitor had 
been copied.

Dependence on imports are a challenge

• The expanded volume of imported medical products and medicinal ingredients is a challenge for the country, said Dr Mohammed Abu Elkhair, Head of Pharma/Medicine and Medical Products Regulation Section, Health Authority of Abu Dhabi.


• Only 20 per cent of the medicines needed in the UAE are manufactured locally, thus increasing a chance of counterfeit trade. “Only increased penalties as proposed in the law can help curb the trade,” he said.


• Quoting a recently held study in Abu Dhabi, Dr Elkhair said only 40-50 per cent of the registered medicines are available in the country.

Current Initiatives

• The UAE will soon end re-exporting of medicinal drugs from its ports to curb a growing regional trade in counterfeit products, according to a senior health official.


• The Health Ministry has also increased raids and inspections and toughened punishments against violators. “Two doctors have recently been blacklisted GCC-wide while in 2008 we closed two factories. This year, 35 pharmacies have been shut down for selling fake drugs,” said Dr Amin Al Amiri.


• Other measures taken by the ministry include quality control analysis, inclusion of new technologies to identify fake medicines, tougher imports control, and advertisement control.

To view the article in its entirety, visit: www.khaleejtimes.com.

MISSION IMPOSSIBLE: IMPORTATION, DEPORTATION & LEVITATION

Charles R. Earl, M.A., ABD
CEO, Communication Connections

One of the elements of President Obama’s Healthcare proposal for the 2010 budget allows for the importation of foreign-made drugs. The supporters claim that off shore sources can provide top-notch pharmaceuticals at prices significantly lower than are available from domestic manufacturers. I have lived a large portion of my life in the Toledo, Ohio area and can recall with clarity the senior citizen bus trips to Canada for the purpose of purchasing lower cost meds. I do not know, however, if the effectiveness of those medications was, at the very least, comparable to those available from US-based sources. If quality can be guaranteed, and if patients and physicians can have absolute confidence in the purity and the efficacy of the drugs, then importation could be a good thing. But…

Most off-shore nations subsidize their pharmaceutical manufacturing and distribution. Will they continue to do so for those meds that are shipped to the United States? Perhaps they may. The Airbus competes with Boeing in the commercial aviation market, and Airbus is highly subsidized by the EU. On the other hand, with exponentially growing demands of their healthcare systems, these nation states may decide that they cannot afford to underwrite a portion of the US system.

In my personal view, people often give the government too much credit for compassion, competence and brains. With the golden ring of universal healthcare within his grasp, the President and his minions have factored in offshore med prices for Medicaid, Medicare, VA and the general population. They sell the concept with compassion, but manage the system like some massive, cold-hearted HMO. Although I am not privy to their formulating the healthcare (634B) portion of the budget, I surmise that they have not calculated for the potential removal of the offshore subsidies or for the possibility that quality control will be seriously compromised. The government is looking only at the buck that they might save. It is a similar attitude that they accuse domestic manufacturers of harboring.

So, regarding importation: domestic manufacturers should be in the room when the plan is implemented, and strict, unyielding safety measures should be utilized to protect the integrity of the drugs. I fear that my beloved Uncle Sam will promise and legislate goodies, but will not follow through on safety. Same old crap.

Now, about deportation. It’s a difficult problem.

And levitation: an uplifting subject whose interest is rising.

The Challenges of Product Safety in a Global Market Place

Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs Administration recently spoke at the Import Safety Summit and posted his view of import safety in his newsletter Andy’s Take:

“You are aware that an increasing number of products – especially those affecting your health, like food and medical products – are being imported from beyond our borders. This has raised great concern recently about FDA’s ability to ensure the safety of those products. This week, I attended a summit with hundreds of industry leaders to collectively address the challenges of product safety in a global market place.

My take is that the challenge of imported product safety will increase because as American consumers, we have come to expect - and even demand – year round variety in the food we eat. And because the production of many of the drugs and medical devices we use is now a global enterprise. So if we are going to want safety in all these products, it will require a collective effort, through collaboration with industry and international regulatory counterparts. This is to build safety in to the production of food and medical products as well as to create systems that assure their safety through distribution and consumption.

That’s why the FDA is accelerating initiatives like our participation in a groundbreaking program with partners in the European Union and Australia. Through a new pilot program we will jointly plan, allocate, and conduct certain inspections of facilities in developing countries that manufacture the starting materials for many of the drugs you take. If this program is successful, it could be expanded to include other types of drug manufacturing facilities. By leveraging the resources of each agency and sharing vital information, the number of foreign facilities in our inspection data base expands while allowing FDA to target its resources on products that we believe present the highest risk to US consumers.”

We at XStream System agree with Commissioner vonEschenbach on the importance of safety throughout the distribution chain and believe that the molecular pharmaceutical authentication possible with the XT250™ Material Identification System will further the industry’s ability to ensure safety to the consumer.

Inter-Industry Summit Discusses Import Safety in Washington DC

A representative from XStream Systems attended a unique event in Washington DC this week. The event, titled the Inter-Industry Import Safety Summit, was an unusual partnership of twelve industry associations and their membership. The impetus behind the summit was an effort to promote a “robust exchange of ideas and information that will further help our industries assure the safety of consumer products regardless of where they are made.”

The gathering of nearly 350 people included speeches by government officials including Michael Leavitt, Secretary of Health and Human Services and Andrew von Eshenbach, Commissioner of the Food and Drug Administration.

Secretary Leavitt, at the Summit, made a significant announcement regarding the U.S. collaborating with the European Union and Australia on inspections of overseas manufacturers of drug ingredients as a way to check more plants. Regulators from the countries will inspect different plants and then share their findings under a pilot program to alleviate duplication and inefficiencies in this process.

In a Medical Products Panel discussion during the Summit, executives from J&J, HDMA, Barr Labs, MedImmune, Schering-Plough and Bayer discussed pharmaceutical safety and the effects of counterfeit and adulterated medications within the Global Supply Chain. The Panel was chaired by Commissioner von Eshenbach from the FDA.

Significant in the Panel discussion was that most were of the opinion that technology needed to be part of the solution of counterfeit and adulterated products within the supply chain and those current initiatives to date with Track and Trace technology is effective to a point but only tracks the transaction of the product.

The industry associations which sponsored the Summit were:

• American National Standards Institute
• Biotechnology Industry Organization
• Consumer Healthcare Products Association
• Food Marketing Institute
• Generic Pharmaceutical Association
• Grocery Manufacturers Association
• Healthcare Distribution Management Association
• National Fisheries Institute
• National Restaurant Association
• Pharmaceutical Research and Manufacturers of America
• Retail Industry Leaders Association
• Toy Industry Association, Inc