Log In

Reset Password

Revised prescription drug bill approved by MPs

Health Minister –Zane DeSilva

MPs have approved legislation to tighten the regulation of imported prescription drugs so they meet the high standards stipulated by other key Western countries.The move by Health Minister Zane DeSilva came after concerns over an order that came into effect on July 1 allowing such drugs to be imported from India, Brazil and Israel.Now, drugs can be imported to Bermuda from anywhere in the world, but they must have been approved for sale in the US, Canada or an EU country and meet the country’s regulatory standards.The move came after concern from pharmacy industry figures over patient safety following Government’s decision to allow drugs from India, Brazil and Israel. The experts, along with the Opposition, cited concern that countries such as India have a problem with counterfeit medication.Before the new bill was passed just after midnight, the law had restricted the importation of prescription drugs based on two conditions; where they are manufactured and where they are approved for sale.Drugs could only be imported from a list of designated countries, which included India, Israel and Brazil after the recent controversial order was approved. Last night’s follow-up legislation scrapped the designated countries list.Now, explained the Minister, prescription drugs may be imported from any country, provided that they meet the regulatory standards of the United States, Canada or European Union. In addition, the product must be eligible for sale in one of those countries.Furthermore, all commercial importers of prescription drugs must register with the Ministry of Health and prove they meet data collection and storage standards.Introducing the bill, Mr DeSilva told MPs: “Following meetings with the representatives of the pharmacy community, I assured them I would make every effort to bring amendments to the (Pharmacy) Act before the House recessed for the summer. I listened, I took action and I’m here today to present those amendments as promised.”He said local prescription drug importers have always stuck to high standards. However, he acknowledged that the act needed to be amended because not all countries have the same regulatory standards.Pharmacy industry figures had been at pains, despite their criticism of Government, to assure patients that they should not be put off embracing generic drugs. Last night, Mr DeSilva said generic drugs, which can be produced cheaply on a mass scale once the patent for brand name drugs has expired, will save money for ordinary Bermudians. The One Bermuda Alliance complained the new law is too ambiguous and suggested an amendment to take the safety measures even further.Its MP Grant Gibbons said in addition to stipulating that drugs imported to Bermuda must be eligible for sale in the US, Canada or EU, they should also “meet the same regulatory, safety and bioequivalence standards” required for importation into one of those countries.Dr Gibbons said the suggested amendment came after consultation with industry experts. He explained the US Food and Drug Administration examines those issues when deciding if a drug can be imported into the US.He explained that bioequivalency standards are checks on whether a generic drug acts the same in patients as the original branded product.Dr Gibbons added that safety standards are important as some low-standard generic drug manufacturers might use the same production line for different types of drugs, leading to dangerous cross contamination.“If we really want to assure people that these generics are as safe, I suggest we take on board this amendment. It will provide additional assurance,” he said.Shadow Minister of Health Louise Jackson also spoke in favour of the amendment. She urged Government to “do the right thing” and accept it “as a small thing to do”.She said the Opposition otherwise backed the bill, albeit with concerns that it should have been tabled sooner.The Government rejected the suggested amendment in a vote after Mr DeSilva questioned which industry experts the Opposition had spoken to about it. He said they had already been consulted and approved the bill as he tabled it. “These amendments were made with every stakeholder that we have in the industry,” he insisted.