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Brodies’ $90,000 worth of imported medication denied entry into Belize

HeadlineBrodies’ $90,000 worth of imported medication denied entry into Belize

MoH says Brodies isn’t complying with new regulations

BELIZE CITY, Thurs. Aug. 30, 2018– Brodies Supermarket has taken to the media to express its concerns over a $90,000 shipment of imported medication that is not being allowed into the country due to new drug regulations set in place by the Ministry of Health (MoH). According to a press release from Brodies, the withholding of the medication is due to the labels being in Turkish, and not English or Spanish. However, the Health ministry is saying there is much more to the story.

In July 2017, MoH established a new law to ensure the quality of the medication being imported into Belize. Under the new law, an importer who is going to import a pharmaceutical product must get the GMP Certificate (Good Manufacturing Practice) and CPP (Certificate of Pharmaceutical Products) for the medication and present it to MoH, who will provide the permit necessary for the medication after the submitted documents have been verified.

After obtaining the permit, importers can then procure the medication but, once they have ordered it, they also need to notify the Ministry of Health of the order prior to the arrival of the goods by presenting the airway bill or similar documents, so MoH can begin to process the customs entry form before the medication arrives into the country.

The permit for each medication lasts for about a year, after which the importer needs to renew it. According to Dr. Marvin Manzanero, Directory of Health Services at the Ministry of Health, the reason for the permit only lasting a year is that the company which manufactures the medication may end up losing its GMP. According to Manzanero, over the past 3 or 4 weeks the GMPs of at least 4 companies have been cancelled.

The 30+ importers in Belize were also given a grace period, from July to November 2017, for all the medications that had already been ordered and were in transit to Belize before the law was enforced.

In Brodies’ press release, they said that they have been importing medications from reputable companies such as Pfizer, GlaxoSmithKline, and Novartis for many years. The medications in question, however, originate in Turkey, and are imported by Brodies from Ziotis Company, with permits from the MoH.  Brodies said that these companies have manufacturing plants in many countries and the labels on the medications are in the language of the country in which they were manufactured.

Brodies’ assertions are that the medications from Ziotis have been held at the airport because of the Turkish labeling. A spokesperson for the business explained that they were under the impression that they would still be able to order the medication, as they have been doing for years, and then affix English labels on them as well as provide an English leaflet insert. However, the government has not allowed this.

Brodies said that they met with an official from MoH in May 2018 to let them know of the Ziotis medications that were ordered from 2017 and were on their way to Belize. Shortly after this meeting, the $90,000 shipment arrived, but has been withheld for 9 weeks and counting.

The Brodies’ release went on to say that the additional problem with the shipment were some discrepancies found by the government after an inspection of the shipment. Brodies described these discrepancies as “mere typographical errors.”

They also said that they were willing to allow the government to withhold the medications with the discrepancies, while they, with permission from the government, adjusted the labels of the remaining medications to English. According to them, they even informed the government that they had cancelled all other orders that have not been shipped yet, and have informed the distributing companies that they will not place any further orders unless they can source the medications in English and provide the proper documentation for them.

Dr. Manzanero told us that Brodies isn’t telling the whole story. He said that Brodies did not inform them of the medications being imported until the container was already at the port, instead of informing them beforehand.

He said that in order to work with them, MoH still started the process to allow the medications into the country. Dr. Manzanero said he met with Brodies 3 or 4 times, starting on May 31, with their legal representatives present. He told them that they would need to send a list of the medications they imported.

This list did not arrive until 8 days later, and it was then that MoH realized that it was actually five containers that had arrived, when they thought it was just one. Although none of the medications met all of the necessary requirements, MoH still allowed four of the containers into the country.

Dr. Manzanero said that there are too many anomalies with the fifth container for him to allow it into the country with good conscience. He said there was no GMP for some of the medications, which is the first thing that is required.

He said that even though all the medications have Turkish labels, he cannot be sure they are from Turkey, since the medications were imported from Ziotis, which is a distributing company based in the UK.  Dr. Manzanero noted, however, that Ziotis only distributes outside of the UK. He said that in essence this means that Ziotis buys medications from distributers who are not allowed to import medications into the UK.

He said another concern arose after the visual inspection. He said what Brodies described as “mere typographical errors” were actually discrepancies with batch numbers, expiration dates, manufacturers and brand names that were different from what they had reported to MoH.

Dr. Manzanero said he wrote them asking them to explain, and it has been over a month and they have not responded. However, they (Brodies) did write Minister of Health Pablo Marin who, after consulting with Dr. Manzanero, wrote them back to explain why the ministry had not released the shipment. He said Brodies has not yet responded to the minister’s letter.

He believes that Brodies, by taking the matter to the media, is simply trying to discredit the work that MoH is doing. According to him, the other importers have no problem complying with new laws and in fact, he has received messages from other importers that express opposition to the shipment being allowed into the country. Dr. Manzanero believes that if he does allow it, he would have no “moral authority” to disallow other importers from doing the same.

Brodies claimed in their press release that a pharmacy in Belmopan is being allowed to import the drugs and relabel them, but MoH says that the drugs Brodies is speaking about were imported during the grace period, and that even Brodies currently has medications with Turkish labels on their shelves, since these medications usually have a 2-year expiry date.

When asked what they suggest Brodies do with the shipment and the prospect of losing $90,000, Dr. Manzanero said he informed them that some companies have had to sell their medications to countries like Guatemala, at a loss. According to him, all the other importers have had to take a loss, and they understand that it was necessary and are doing their best to comply with the new law.

When we spoke with a representative from Brodies today, they denied these allegations. The representative stressed that they have always complied with the laws of the country and will continue to do so; however, it just so happened that this last shipment had been in transit for months and had not arrived before the grace period had ended.

The Brodies representative said they met with Dr. Manzanero prior to the arrival of the shipment and they took a few days to present the list of medications to him, because they were proposing to relabel the medications and their marketing department was working on the labels. The Brodies representative said that by the time Dr. Manzanero got back to them, the shipment had already arrived at the airport.

Concerning the GMP certificates, the representative explained that some of them had expired for the 4 containers that contained US brand medications such as Advil, and it takes 6 months to renew the GMP. However, even for these 4 containers with well-known medications, the MoH still did not release them immediately.

The representative said that although they have done their best to explain the situation to MoH, the ministry is still refusing to release the final container, and this comes as a shock to them.

With regards to the anomalies of the final container, the representative insisted that they believe it is “typographical errors” and they had indeed informed MoH that they were willing to discard the medications with the discrepancies, as they had said in their release.

The representative also claims that they have responded to every email from the Ministry.

The representative said there are customers who are in need of their medication and Brodies would hope that the Ministry would allow this final shipment, all things having been considered. In fact, MoH has released two of the medications in the same shipment to patients who had special-ordered it. Brodies wonders, then, why the rest of the shipment can’t be released.

The representative said it appears that they will have to destroy the shipment, since it is being held in storage and they have had to pay for it to be kept for the past 9 weeks. According to them, they have asked MoH how to go about destroying the medications, but have received no response.

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