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Tatev Khachatryan

Drug Monopoly in Armenia: Testing Center Wields Powerful Boycott Regarding Imports

Recently, there have been frequent cases when Armenia’s Scientific Center of Drug/Medical Technology Expertise (SCDMTE) has prohibited the importation of foreign medicine to the country.

The reasons given are diverse and mostly for marketing interests.

The Center, as a leading player in Armenia’s medicine market, is creating unfair business conditions and stifling competition as it wields a powerful boycott tool.

This article examines the problems faced by one importer trying to get a toehold in Armenia’s lucrative medicines market.

Hovhannes Martirosyan is a biology PhD. candidate and a pharmacologist. He served as the SCDMTE’s licensing department chief from 1992-1998 and worked in Armenia’s health system until 2005. Founding his own drug business in Moscow, he recently decided to import medicine to Armenia, at cheaper prices, via his Vitapharm company. It hasn’t been smooth sailing.

To import a medicine to Armenia, it must be registered in the state registry. The Hungarian company Gedeon Richter produces Quamatel20 mg. – (a drug administered orally for the short-term (two months) treatment and, at reduced dosage, the long term prevention, of peptic ulcers, for the relief ofsymptoms associated with hyperacidity, such as heartburn and acid indigestion, and for the treatment of gastro-esophageal reflux disease and upper gastrointestinal bleeding.)

In Armenia, the drug is registered with a four year shelf life and can be imported until November 2019. “We brought the Quamatel but the SCDMTE rejected us,” says Martirosyan. “The tested the medicine and rejected it saying that in Armenia Quamatel is registered as having a four year shelf life and the stuff you’ve brought has a five year expiration.

We won’t allow it.” According to Armenian government Decision #N581 regarding the import and export of drugs the remaining minimum shelf life of a drug/medicament, at the time of import, must be one year.

Gedeon Richter produces the same Quamatel 20mg. for other countries with five year expiration. So why is it being denied entry to Armenia?

Martirosyan then went to Armenia’s Ministry of Health and a series of hearings were organized. “I asked why four years in Armenia?” says Martirosyan. “The SCDMTE specialist responded that the manufacturer had contacted them and stated that the drug’s quality decreases after four years and that’s why we register it at four years. If the drug’s quality diminishes after five years, why have the Hungarians registered it in their country at five years? No one can answer this.”

What is interesting is that Gedeon Richter manufacturers a Quamatel 40mg dosage that is registered in Armenia with a five year shelf life.

One doesn’t have to be a druggist to understand that if you cut a 40mg tablet in half its shelf life doesn’t decrease to become four years.

Martirosyan says his company was planning to sell the medicine in Armenia to distributors at a price 60% cheaper than others. “There are some medicaments where they give a 300% difference in the price,” he said.

Galazolin

Another problem arose regarding the nose drop Galazolin (Narrows the blood vessels of the nasal mucosa, reduces congestion, edema and the amount of discharge.) The drug is manufactured by the polish Polfa company.

Throughout the world it is registered and sold as “Galazolin”, adding below “0.1% nose drops”. In Armenia, they have registered it as “Galazolin 0.1%”. In essence, the same imported drug is registered in Armenian under a different name.

Government Decision N581, Point 18 “Only medicines with a state registration in Armenia can be imported to Armenia, the packaging changes of which do not impact the products’ safety, efficacy and quality, and where there exists the original quality certificate of the manufacturer, or a copy of the certificate given to an importer of other countries by the manufacturer, verified by the exporting organization’s stamp.”

Cerucal

Cerucal (tablets to treat disorders of the upper gastro-intestinal tract such as irritable stomach, heartburn, reflux oesophagitis, etc), is manufactured by the Croatian Pliva company which was owned by the German AWD pharma GmbH.

Recently, Pliva has since been incorporated into the Israeli TEVA company.

“We brought the drug here noting that the legal owner is TEVA. Authorities in Armenia told us that in the registry the owner is noted as AWD and we won’t permit its importation,” says Martirosyan.

The ownership change was never made in Armenia’s registry.

Halixol

A similar problem arose regarding the importation of the Halixol cough syrup. In Armenia, the medication was registered as produced by the Hungarian firm Egis OJSC, whereas Egis has since become a CJSC. Boxes of the drug imported to Armenia show Egis CJSC. The SCDMTE suggested that Martirosyan contact the Egis company representative in Armenia.

The representative got back to Martirosyan, telling him that they’ve already renamed seven medicines under the CJSC mark, but haven’t yet done so for Halixol. They said that the change hasn’t been made because they still have boxes of Halixol marked as OJSC and they won’t make any changes until they are sold.

Just days ago, the Egis rep told Martirosyan that the supply had been sold and the name change made. Martirosyan can now sell the drug.

Metrogyl

The Indian manufactured drug Metrogyl (used to treat dental, gastrointestinal and genital infections) presented no problems. But it’s still in the warehouse because the SCDMTE demanded that the batch certificate be presented. It wasn’t asked to be shown when the drug was imported.

Finlepsin

Finlepsin, an anticonvulsant medication and a mood-stabilizing agent produced by the Israeli TEVA company, is also awaiting a batch certificate. It had been prescribed in Armenia but was replaced in 2013 by Carbamazepine. Many have complained about nasty side effects after taking the replacement produced by ARPIMED LLC .

Martirosyan says it’s all designed to drag out the process. “We petitioned the SCDMTE and have been waiting for the batch certificate since September 29,” he said.

Overall, seven drug brands imported to Armenia by Vitapharm have been rejected. None of those rejected had a quality issue.

Martirosyan has since gone to the courts to resolve the above issues.

Honorary Consuls - Gedeon Richter Ltd. Shareholders

The only company that has imported Quamatel and any other drug manufactured by the Hungarian firm Gedeon Richter to Armenia since 1992, has been Gedeon Richter Ltd. registered in Armenia.

51% of the latter is owned by the Hungarian Gedeon Richter parent and five individuals own 9.8% each.

One of the individuals is Ruben Astvatsatrian (Honorary Consul of the Republic of Slovenia) in Armenia. Another is Levon Saghatelyan (Honorary Consul of the Republic of Lithuania) in Armenia.

The two have been granted the right to conduct commercial business in Armenia by the RA Ministry of Foreign Affairs.

(To be continued)

 

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