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Warning that new rules on prescription drugs could backfire

Bitter pill? Legislation that allows the importation of generic drugs from a wider range of countries could lead to higher drug bills, according to the Bermuda Pharmaceutical Association.

Legislation that allows the importation of generic drugs could lead to higher drug bills, according to the Bermuda Pharmaceutical Association (BPA).BPA president Stephanie Simons said that local pharmacists work to encourage generic drugs, which are less expensive and equally effective.But she warned that if pharmacists or the public are not confident in the generic brand, they will instead turn to more expensive brand name drugs.In a letter addressed to Health Minister Zane DeSilva, she wrote: “We have already been asked if generics being supplied are from India.“While the intent of this order is to further reduce the costs of medication to the public, there is the possibility that costs will rise if customers insist on being supplied with brand name medications.”On June 17, Mr DeSilva tabled the Pharmacy and Poisons (Designation of Approved Countries) Order 2011, which as of July 1 allows the importation of prescription drugs from Brazil, India and Israel.The move was explained as an effort to reduce the cost of prescription drugs to Bermudians, but the move has sparked a backlash in the pharmaceutical community, who expressed concerns about the regulation of the drugs.Concern was also expressed about the lack of consultation with local pharmaceutical representatives, such as the BPA and Lynanne Bolton, the Pharmacy Inspector and Consultant for the Bermuda Government.While Mr DeSilva said in a recent statement that brand name drugs are made in counties like India, Ms Bolton said that in those cases, the factory is regulated by the drug manufacturer not the country.“There are no regulations in place at the moment to control the quality of drugs imported into Bermuda,” she said. “There is just the list of countries that [Mr DeSilva] has now added to.“Until now, we have been confident that drugs imported from the countries on the list, with the exception of Russia, are of an acceptable standard.“We don’t have testing facilities in Bermuda and the companies we are worried about in India and elsewhere are not high profile companies like Merck and Pfizer, but generic drug manufacturers who may not apply the same high standards.”The issue was broached in the House of Assembly by OBA Minister Louise Jackson, who asked for the implementation of the legislation to be delayed until regulations are in place.Noting that the Ministry had not consulted Ms Bolton, Mrs Jackson said: “If she is not consulted, given she is a Government consultant, that is alarming right there.”However, after speaking for a short while, Speaker of the House Stanley Lowe ended the debate, noting that the Minister was not present in the House to answer any questions or respond.In a statement issued to The Royal Gazette, Mrs Jackson said that the spread of counterfeit drugs is a major issue that could have real consequences on the Island if drugs are not properly regulated.“In Brazil in 1998, approximately 200 unwanted pregnancies resulted from the use of counterfeit contraceptive tablets,” she said.“And according to a recent World Health Organisation report, India leads in counterfeit drug production, with as much as 35 percent of the worlds production.”She called for a quality stamp for prescription drugs that have been confirmed as a valid, and for the Ministry of Health to consult with the BPA and others in the pharmaceutical field.“Delay this legislation and amend the legislation to require the manufacturing facilities and the drugs they produce to be approved by regulatory authorities of either the USA, Canada or Europe.”l Editorial see page 4