Govt: No U-turn on new drug rules
Minister of Health Zane DeSilva said he has noted concerns that a new order could allow counterfeit drugs into Bermuda, but Government will not do a U-turn on the new rules.Mr DeSilva said this afternoon he was surprised at the level of anxiety shown by pharmacy industry stakeholders who have spoken out publically over the issue, complaining that they were not consulted.He added: “The local wholesalers and the retailers who import drugs from overseas are very careful to ensure that they purchase from reputable suppliers.”The debate began when Mr DeSilva tabled the Pharmacy and Poisons (Designation of Approved Countries) Order 2011 on June 17 in a bid to drive down healthcare costs.The order, which came into force today, July 1, allows prescription drugs to be imported from Brazil, India and Israel for the first time.However, legislation to ensure the medicine meets international best practice manufacturing standards is unlikely to come into effect until the end of the year.When he tabled the order, 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.However, Opposition Senator Kathy Michelmore, who is a physician, raised concerns in the Upper Chamber on Wednesday, saying: “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 on Wednesday: “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.”On Thursday, Lynanne Bolton, Pharmacy Inspector and Consultant to the Bermuda Government said: “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 [on] July 1 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 [ i.e prescription] 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.”Responding to the concerns this afternoon, Mr DeSilva issued a statement through a spokeswoman who said “he has been carefully following the discussion taking place regarding the importation of prescription drugs into Bermuda”.Mr DeSilva said: “When I took on the role of Minister of Health in November, 2010, one of the objectives which had been set for the Ministry was to formulate ‘ways to obtain quality prescription drugs, on a more cost-effective basis.’ So, when I first announced that Brazil, India and Israel would be added to the list of countries from which drugs could be imported, I stressed that we have to find ways of reducing the cost of healthcare. One way to do this is to provide drug importers with options.”He said that until today, medications from some of the largest producers of generics could not legally be imported.According to the spokeswoman, “he also expressed surprise at the level of anxiety being shown and wondered why there was no similar outcry in February of 2009 when Russia was added to the list of approved countries”.The statement added: “Since announcing the changes, the Minister has received letters from various organisations representing pharmacists expressing concern about the quality of drugs that could be imported from the countries added to the list of ‘designated countries’. However, it should be pointed out that the regulations which control the quality of drugs imported into Bermuda have not changed.“The rules which controlled the importation of drugs from Slovenia, for example, are the same rules which control the importation of drugs from Israel. The local wholesalers and the retailers who import drugs from overseas are very careful to ensure that they purchase from reputable suppliers. In turn, the pharmacists work exceptionally hard to ensure that their customers receive only the highest quality prescription drugs. This is not expected to change.“What may change is that markets which previously could not be accessed are now available to importers who will continue to look for high quality products, but at a lower price.”The Minister added: “Major drug companies such as Merck, GlaxoSmithKline, Pfizer and others have manufacturing facilities in India. If Indian drug regulatory authorities were sub-standard, I’m sure those companies would not have facilities there.“I have considered the requests for the implementation of the Designated Countries Order to be delayed, and I have heard the argument that unscrupulous importers could import counterfeit drugs from the countries being added to the list. But there was nothing stopping the importation of counterfeit drugs from the countries that are already on the list.“I am confident that our importers will continue to abide by the letter and the spirit of the law and only bring in high quality products from high quality manufacturers. I am also confident that our pharmacists will continue to serve the public as they have in the past by providing exceptional service when they dispense medications.”The spokeswoman said the Minister has “received a number of very positive suggestions on additional changes that could be made to the legislation which would allow drug importation from an even larger pool of countries while maintaining drug security.”She said: “He is actively considering these suggestions to see how they can be incorporated into the current act.”