Pharmacists and doctors have raised fears that dangerous counterfeit drugs could make their way into Bermuda under new rules coming into effect tomorrow.An order made by Health Minister Zane DeSilva in a bid to drive down healthcare costs will allow prescription drugs from Brazil, Israel and India to be imported to the Island for the first time.But legislation to ensure the medicine meets international best practice manufacturing standards is unlikely to come into effect until the end of the year.Bermuda Pharmaceutical Association, which represents all pharmacies on the Island, says that could mean ineffective or harmful drugs make their way onto the market.It is urging Government to hold off on allowing drugs from Brazil, Israel and India into Bermuda until the necessary legislation to ensure the quality of the medicine is approved by Parliament.Opposition Senator Kathy Michelmore raised the issue in the Upper Chamber yesterday, stating: “Some of those countries don’t have appropriate controls to ensure that they are genuine drugs.”Stephanie Simons, president of Bermuda Pharmaceutical Association, told The Royal Gazette: “There is such an increase in the instance of counterfeit drugs on the market now.“There’s a strong feeling that we need to have some controls in place so that we don’t have these medications imported into the Island.“Our primary concern is the safety of the public. We do need to look at the costs of medications. [But] what’s the point of bringing in something that’s very inexpensive where there’s a potential to do harm?”The Association, the Pharmacy Inspector and Bermuda Pharmacy Council were not consulted before the Pharmacy and Poisons (Designation of Approved Countries) Order 2011 was tabled by Mr DeSilva in the House of Assembly on June 17.The Minister told MPs that adding Brazil, India and Israel to the list of approved countries of origin for the importation of medicines would give Bermudians a wider choice of prescription drugs.He said the three countries were “leaders in the manufacturing of generic drugs” and that these were usually cheaper than brand-name drugs.Ms Simons said: “We have worked quite a long time in the pharmacy profession trying to encourage patients to take generic medication wherever possible.“But if we run into a situation now where there’s some question as to the origins of the medication, that’s going to put some doubt in customers’ minds.”She said worried patients were then likely to opt for the brand-name drug, which would increase costs.“I don’t think there’s been a lot of thought put into this,” she said of the order. “[We are asking] that it’s held off until there’s a little bit more due diligence done, so we can ensure that whatever comes into the Island from those places is, in fact, safe for the public to take.”Pharmacist Sheryl Martins, of Caesar’s, in Sandys, said: “Our major concern is that wherever we get it [medicine] from, we want to make sure that the manufacturing plants are actually regulated so we can ensure we are not receiving counterfeit drugs.”She said countries already approved for importation to Bermuda included the US, Canada and member states of the European Union. “We know what the regulations are [in those countries]. We don’t know about these three countries and we are trying to get information.”Ms Simons said local wholesalers had given guarantees they would only import drugs meeting certain standards and pharmacists ordering medicine on an individual basis would only import from countries where the “efficacy and effectiveness” of the drugs could be guaranteed.But she said hospital patients may not get a choice in terms of the drug administered to them. “The hospital will be wanting to ensure that what they are getting in is of a certain quality as well,” she said.“I would hope that they would have safeguards in place to ensure safety.”A spokeswoman for Bermuda Hospitals Board said last night: “We have due diligence processes in place relating to the procurement of drugs to ensure quality and safety and these will continue.”George Grundmuller, president and CEO of Phoenix Stores, said the order ought to have been made effective at the same time as strengthened regulations on importation.“Otherwise, it could create a grey zone in between,” he said. “What I think is very important for the Island is that we maintain the safety of the drug supply.“I think that has to be the top priority. We won’t bring in any drugs where we are not absolutely sure of where the drugs came from and we can verify the drug safety.”John Tomlinson, president and CEO of BGA Group, said: “As a long line importer of pharmaceuticals to Bermuda, the safety of patients is the single most important factor we consider.“We also have a responsibility to provide Bermuda with branded and generic drugs at the most competitive pricing, within the framework of the law.“Efficacy of the product we import to Bermuda is absolutely critical to ensure the safety of the consumer and we work tirelessly with our external suppliers as well as advocates within Bermuda, such as the Chief Medical Officer and the Pharmacy Inspector, to ensure that.“Any legislative changes that might weaken the robust laws and controls that are in place in Bermuda today, and which have served Bermuda well, without proper and extensive consultation, might have unintended consequences.“Caution and thoughtful planning would be appropriate when legislative changes in this area are being considered.”GP Burton Butterfield said he was unsure how the Ministry of Health came to its decision.“The concern is the quality of the medication that will be coming from these other countries.“We don’t know what the standard is. We don’t know if the approval process is the same standard that we are used it.”He added: “All the pharmacies have to do is not order them. They certainly can’t force any pharmacy to buy a particular brand; all you can say is that they are available.”During the Senate motion to adjourn debate, Sen Michelmore accused Government of failing to consult with local pharmacists before widening the list of approved countries.The Shadow Health Minister said: “We must balance the need to reduce the costs and defer against the very real threat of counterfeit medication.”She said Government was putting the cart before the horse by allowing more drugs into the country before ensuring appropriate controls were in place.Independent Senator Joan Dillas-Wright echoed those concerns, warning: “Unscrupulous people in certain parts of the world are after the dollars.”Mr DeSilva is expected to table an amendment to the Pharmacy and Poisons Act 1979 regarding the importation of prescription drugs in the next parliamentary session.It is likely to require that:l all prescription drug importers register with the Department of Health;l that the country of manufacture be approved rather than the country of origin; andl that the manufacturing plant meets international best practice and has been approved by the drug regulatory authority of either the US, Canada or one of the EU member states.Today Lynanne Bolton, Pharmacy Inspector and Consultant to the Bermuda Government, issued a statement which said: "As The Pharmacy Inspector and Consultant to the Government I can confirm that I was not consulted prior to the Minister of Health’s statement on June 17 that he had decided to add Brazil, India and Israel to the list of designated countries from which prescription drugs can be legally and freely imported into Bermuda."He indicated at that time that the Pharmacy Act would be amended later this year to create certain safeguards to public health by requiring the manufacturing facilities and the drugs they produce to be approved by the regulatory authorities of either the USA, Canada or Europe. I am however gravely concerned that if the Ministerial order comes into effect tomorrow, July 1st. without these safeguards in place, there is nothing to stop sub-standard or counterfeit drugs finding their way into Bermuda pharmacies and into our two hospitals."Upon learning of the order I met with the Minister and Permanent Secretary and advised them that, while I share their desire to lower the costs of Rx drugs in Bermuda, the safety of our people need not and should not be compromised in this way. The Order and the amendments to the Pharmacy Act need to be introduced together to protect the public from sub-standard and counterfeit drugs."I know that my concerns are shared by the Pharmacy Council, the members of the Bermuda Pharmaceutical Association and many of the island’s doctors and dentists."Even at this late stage I hope that the Government will delay the order until such time as the amendments which they plan to enact can be implemented."The Ministry of Health did not respond to a request for comment.lUseful websites: www.bpa.bm, www.who.int/mediacentre/factsheets/fs275/en/