Generic drugs: Sifting fact from fiction

WEDNESDAY, JULY 13: Government has courted controversy with new regulations on the import of prescription drugs.

Amid a deluge of information and differing opinions about what the changes might mean, patients have been left confused.

James Whittaker talked to medical professionals and Government officials to explain the new policies and answer the important questions that affect you.

Will your drugs be coming from India, will you save money and is your medicine safe?

What are the new regulations?

Historically Bermudian businesses have only been able to import prescription medication from the US, Canada, the UK, Switzerland, Australia and the EU.

Russia was added to the list in 2009.

Health Minister Zane DeSilva announced last month that Brazil, India and Israel would be added as well.

The decision sparked concerns from all sectors of the medical community, including Government’s pharmacy inspector, the Pharmacy Council and a host of health professionals. They said they did not disagree with the idea of opening up the list.

But they believed this should be done concurrently with amendments to the Pharmacy Act requiring all imported drugs to meet the regulatory requirements of the UK, US or Canada.

Health Minister Zane DeSilva announced on Friday that he had taken those concerns on board and will introduce legislation to that effect this week.

The amendments will also mean there is no longer a specific ‘list’ of accepted countries. Bermuda will be opened up to drugs from anywhere in the world as long as certain safeguards are in place to ensure the quality and reliability of drugs from these countries.

Why the change?

The aim, according to Minister DeSilva is to make prescription drugs cheaper for ‘Mr and Mrs Bermuda’. Health professionals have expressed doubt over whether this will prove to be the case in practice.

Lifting regulations could potentially open up new opportunities for pharmacies and the hospital to buy in different ‘generic’ equivalents to brand name drugs.

Generics, already available in Bermuda for many drugs, are cheaper than their brand name equivalents. It is possible that generic drugs, manufactured in India for example, could be cheaper than an equivalent drug manufactured in the US.

The change could also increase options for pharmacies if they run into supply problems with existing vendors — an increasing issue amid a worldwide drug shortage.

But will it save patients money?

The direct benefit to Mr and Mrs Bermuda is somewhat questionable as most major health insurers in Bermuda already cover 100 per cent of the prescription costs for generic drugs.

It is possible savings may be passed on in the form of cheaper insurance premiums further down the line.

This is how Govenment explains it: “Essentially, if a drug (whether it is a generic or brand name drug) is manufactured in a plant in country X, and we do not allow importation from that country, then the drug cannot come into Bermuda.

“If that drug is cheaper than the same drug manufactured in other countries (and just as effective and just as safe), it means that only the higher cost drug from the countries currently on the list could be imported. The amendments to the Act will resolve that by allowing the importation of drugs from any country while at the same time safeguarding quality and effectiveness.”

One pharmacy source said the short-term effect of the legislation may actually push costs up.

They said the dispute over Government’s initial failure to ensure a safe regulatory framework to accompany its decision to allow drugs from new import markets had stoked public fears. Many patients, according to the source, are confused about the safety of generic drugs and are requesting more expensive brand names.

What are generic drugs and why are they so much cheaper?

Generic drugs can be significantly cheaper than their brand name equivalents, even though the chemical make-up of the drug is identical.

Generics are not advertised and so there are no additional costs connected to marketing campaigns which is not the case with brand name drugs. (For example, Nexium — ‘the little purple pill’ — spent $16m in a single month advertising the heartburn medication, according to trade publication Medical Marketing and Media)

Brand name drugs also cost many millions for research and development.

However these costs are already protected by patents, which provide the ‘discovering’ company with exclusive rights to manufacture the drug for a set period.

Once that patent expires it becomes a free market and other manufacturing companies are allowed to produce generic equivalents from the same chemical formula.

The original brand name companies often rely on patients being unaware of this change or having developed brand loyalty to a particular drug (for example, “Zocor worked for my heart disease for ten years I’m not changing now”) and customer scepticism as to how a bland-looking package with a confusing name could be so much cheaper.

Can I trust generic drugs?

There are already generic versions of almost every drug (that is not patent protected) on the market in Bermuda.

As previously stated they are identical to the brand name alternatives and can absolutely be trusted. In countries like the UK (which has a Government-run health system) it is mandatory for doctors to prescribe generics when they are available.

Some pharmacists in Bermuda report that they do have a hard time convincing patients to steer clear of the costly brand names.

Even for over-the-counter drugs, where marketing is the biggest factor, customers often opt for well-advertised brands over the same but cheaper product.

Perhaps a better way of putting money back in the pocket of ‘Mr and Mrs Bermuda’, say some pharmacists, would be to either ban the advertising of drugs (as in the UK) or a public awareness campaign about the cost benefits of generic drugs.

Why is the debate focused on India?

India is a boom economy for the production of everything from auto parts to prescription drugs.

India is the leading manufacturer of generic drugs and a likely source of future imports. But regulatory standards in India are notoriously weak.

Counterfeit drugs — sometimes produced in shabby home-factories but looking amazingly authentic — can find their way, illegally, into the mainstream. Some have even found their way into the US (more on this later).

Patients paying hefty monthly health insurance premiums in Bermuda have the right to expect the drugs they are prescribed have been regulated with the same rigour as drugs on the market in other affluent western countries.

The American Food and Drug Agency does have a presence in India and can and does regulate exports to the US.

The changes to the regulations — proposed by Minister DeSilva on Friday after lobbying from health professionals — should ensure that any exports from India (or any other country) meet those regulatory standards.

So can I trust drugs from India?

The important question to ask is not so much where was the drug manufactured but where it was tested and approved. If a drug was made in India and only approved by India, pharmacists in Bermuda would not buy it (this will be legally binding when the new law comes into effect).

However, if a drug was made in India but tested and approved by the FDA, one of the toughest regulating authorities in the world, a pharmacist in Bermuda would be able to guarantee the product’s authenticity.

So ‘made in India’ is not necessarily a problem. The important point is regulation.

Why not just take drugs from India and other countries, regardless of US or English approval?

The US, EU and Canada are renowned as holding the highest standards in the world for drug safety.

Whereas people in impoverished countries may be willing to take a chance on unregulated drugs from Indian manufacturers, Bermudians should not be expected to do so.

It’s clearly unrealistic for Bermuda to have its own equivalent of the FDA, so it seems a sensible policy to follow the lead of other western nations.

What are the potential problems with unregulated drugs?

At the extreme end of the scale, counterfeit drugs are becoming a huge global problem.

A flourishing multi-million dollar black market in fake drugs is a growing concern for law enforcement worldwide.

A recent 60 Minutes investigation exposed rogue counterfeiters, including a Peruvian home factory producing drugs from chalk and sugar. The programme reported that similar counterfeited drugs were finding their way to the US via Internet ‘pharmacies’.

Other legitimate drug production companies may not meet the same standards expected by western medics. For example, an Indian factory may be operating quite legitimately under that country’s own regulatory framework but it may not meet the stricter standards of cleanliness and safety control required for FDA (or equivalent) approval.

Where does Dr Ewart Brown come into the equation?

Little over a month after Minister De Silva announced his decision to allow drugs to be imported from India, Brazil and Israel, a new company was incorporated in the Official Gazette (published in the Bermuda Sun).

The company Bermuda Healthcare Agency listed Dr Brown, Rolfe Commissiong and Ven Subramanian, the Indian businessman who linked with Dr Brown when he was Premier in a plan to bring Bollywood movies to Bermuda.

The company has not yet listed its aims with the Registrar of Companies and none of the directors have made public statements about what business it will engage in.

This sparked speculation that the former Premier was about to exploit the new law by setting up a business importing drugs from India. This would have raised ethical questions about whether the directors had used political influence to change the law in order to create a business opportunity for themselves.

However, it has since been denied that the new company will be involved in importing drugs from India. Minister DeSilva, a friend of the former Premier, also denied that was the case in the House of Assembly on Friday, saying “nothing could be further from the truth”.