Govt moves ahead with new rules on prescription drugs

Make text smaller Make text larger

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 he was surprised at the level of anxiety shown by pharmacy industry stakeholders who have spoken out publicly over the issue, complaining 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.”

She added in a follow-up statement yesterday: “The Pharmacy and Poisons Act 1979 is sadly out of date and needs to be amended sooner rather than later.

“We have forwarded our concerns to the Minister of Health and await a response from him. We don’t want people to be afraid of generics; we currently have access to and supply of many excellent products that have been licensed by authorities in the United States, United Kingdom or Canada for use in those countries. We want to be sure that we can continue to provide the same quality of medication which might be imported into Bermuda from any other jurisdiction.”

On Thursday, Lynanne Bolton, Pharmacy Inspector and Consultant to the Bermuda Government, said she was not consulted prior to the order being made and called for its implementation to be delayed.

She said she was “gravely concerned” at the prospect of the order coming into place without the Pharmacy Act being amended to create safeguards to by requiring the manufacturing facilities and the drugs they produce to be approved by the regulatory authorities of either the USA, Canada or Europe.

Without the safeguards, said Ms Bolton: “There is nothing to stop substandard or counterfeit drugs finding their way into Bermuda pharmacies and into our two hospitals.”

Responding to the concerns yesterday afternoon, Mr DeSilva issued a statement through a spokeswoman saying: “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.”

The Minister said that until yesterday, 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 substandard, 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.”

Make text smaller Make text larger

Related Stories

Take Our Poll