RAY

The Malaysia Insider
Stiffer penalties for trading in fake medicines

KUALA LUMPUR, Sept 21 — Pharmaceutical counterfeiters beware – stiffer penalties, including mandatory jail sentences, are in the offing by Malaysian legislators in the fight against fake medicine.

In realising the threat to the national health and the local as well as global pharmaceutical industry, the Ministry of Health is putting in a new bill next year to combat the menace.

In an industry roundtable discussion comprising representatives from the government, global pharmaceutical companies and related organisations here recently, the participants called for stricter and more effective mechanisms in the war against counterfeit medicine.

The roundtable discussion was under the auspices of the Special Taskforce to combat Counterfeit Products, a unit established this year under the purview of the Ministry of Domestic Trade & Consumer Affairs (MDTCA), and the Pharmaceutical Association of Malaysia (PhAMA).

A counterfeit medicine is defined as one which has been deliberately and fraudulently mislabelled with respect to identity and/or source.

Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging.

Currently counterfeit medicine account for approximately 10 per cent of the world’s supply of medicine, or US$22 billion (RM74 nillion), and will grow to become 16 per cent of the total aggregate size of the legitimate industry.

Counterfeit medicines sales are expected to grow 13 per cent annually through 2010, compared to just 7.5 per cent estimated annual growth for the legitimate global pharmaceutical trade.

In Malaysia, between January and August 2007, about RM25.8 million worth of unregistered and adulterated drugs were seized during raids on manufacturing outlets and the balance seized at entry points.

Of late, counterfeit medicine, especially fake sex stimulants, have been marketed via the Internet to unsuspecting buyers.

Linda Wang, who was representing the Malaysian International Chamber of Commerce & Industry in the task force, proposed more severe penalties for criminals caught manufacturing, supplying or selling counterfeit drugs.

She recommended that the Trade Descriptions Act 1972, Sales of Drugs Act 1952 and Poisons Act 1952 be amended to provide heavier punishment.

“There should be a mandatory minimum fine per counterfeit item and mandatory minimum jail sentences (the current provisions only prescribe an upper limit but no lower limit). The possession of three or more items of counterfeit drugs is to be presumed, unless proven otherwise, used for sale and not for private or domestic use,” said Wang, a lawyer by profession.

She said the industry was joining forces to find a workable solution to this problem.

With increased awareness, Wang hoped that there would be greater focus in addressing the issue of counterfeiting medicine which was a serious crime.

“Putting an end to counterfeit medicine is the responsibility of everyone and all Malaysians must learn to be more accountable for the medicines they consume,” she said.

As for getting enforcement agencies to be aware of counterfeit medicine, the roundtable discussion was told that major pharmaceutical companies constantly held courses and workshops.

Mazlan Ismail, Senior Assistant Director of Enforcement at the Pharmaceutical Services Division in the Ministry of Health, said counterfeit medicine accounted for about 5.28 percent of over the counter self-medication products in Malaysia.

The value of seizures of counterfeit medicine in the Malaysian market last year amounted to about RM35.836 million compared to RM25.884 million worth of seizures in 2004.

“Of the counterfeit medicine products seized in 2007, sex stimulants accounted for the bulk at 40 per cent while 10 percent were slimming products.

The balance comprised scheduled poisons and other categories of pharmaceutical products,” Mazlan said, adding that the Ministry of Health would be pressing for more deterrent sentences in the new bill as a result of the magnitude of the problem.

He revealed although the Malaysian authorities had introduced hologram labels to check against counterfeit products, the counterfeiters had circumvented the ruling by resorting to fake hologram labels, which even fooled licensed pharmacies.

In this regard, Mazlan said his ministry had distributed several thousand units of detection decoders to licensed pharmacies all over the country for consumers to verify the authenticity of the product.

“If the decoder blinks against a hologram, then the product is genuine,” he explained, adding that fake holograms could not interface with the decoders.

The director of the Enforcement Division in MDTCA, Haji Mohd Roslan Mahayudin, in highlighting the changing landscape of the counterfeiting industry, said counterfeiters had become more sophisticated in tricking consumers into buying fake products through advances in technology, especially in the packaging.

“It has now become a lucrative business and attracting even organised crime,” he said, adding that counterfeit medicine had also infiltrated the supply chain of under-regulated wholesalers.

In view of this, he said the pharmaceutical industry needed to identify new technologies to make products counterfeit-proof.

“Malaysia needs to raise the bar in managing the fight against counterfeit medicine. The consensus is that there is an urgent need to educate and empower all Malaysian consumers to take responsibility for their medicine,” said Roslan.

Ivan Ho, the Director of Asia Pacific for Global Security at Pfizer Inc, one of the world’s pharmaceutical giants, stressed on the need to step up stricter enforcement measures to stop the infiltration of counterfeit medicine in the supply chain.

Local government authorities, he said, also needed to be educated on the realities of counterfeit medicine, which had become a nightmare to public health and impacted the pharmaceutical industry.

Ho has even forecast that the value of counterfeit medicine globally by 2010 to be at US$75 billion.

“This is a scary figure, considering the implications on the public health and industry,” he said.

Ho warned that fraudsters had no regard for the safety of consumers and often did not adhere to hygienic conditions when producing bogus medicine, where the dosage of active ingredients may vary, either too much, which would lead to disastrous consequences, or sometimes, nothing at all.

“We must continue to invest in driving ongoing consumer awareness as there is a need for all of us, including consumers, to take responsibility for our medicine,” he said.

Raymond Velez, Regional Manager for Global Product Protection (Asia Pacific) at Eli Lilly, another pharmaceutical giant, said no market was spared from the presence of counterfeit medicine.

“Therefore if it requires enforcement against a drug store chain or an influential person, it must be done,” he said, adding that the business was actually driven by mid and low-level distributors in receiving countries.

He contended that if there was no demand from importers, there would not be any business for counterfeiters.

Velez said enforcement agencies and industry players should go all out against counterfeiters by tracing the source of the fakes.

“You have to go out there and look for it. It consists of different pieces of puzzles to be put together,” he said.

Continence Foundation of Malaysia President, Dr Peter Ng called on health ministries in the region to work together to notify one another on the effects of counterfeit medicine affecting unsuspecting victims.

“That would make it easier for us to diagnose the symptoms when patients come in,” he said.

Dr Ng said there was a recent case in Malaysia of an 80 year-old man with erectile dysfunction who took a fake potency pill and subsequently got into all kinds of health complications.

He also revealed that an increasing number of pharmacies in Malaysia had pharmacists taking over the role of doctors by taking blood pressure, conducting blood tests and even prescribing medicine.

“That should be left to the doctors,” he declared, adding that a line must be drawn and that such transgressions should be acted upon by the authorities. — Bernama