Generic medicines in most cases cost significantly less than their branded counterparts but their use depends on doctors prescribing them and on pharmacists stocking them - and offering them as substitutes.

A man walks into a pharmacy.... It may sound like the start of a joke but for people who take medication it is far from funny.

The man was prescribed a drug that cost over Lm12 for a week's supply. When he baulked at this, the doctor offered a rival brand that cost Lm9 but even then, he was not told about a generic equivalent that cost under Lm4, a savings per week of Lm9 over the original prescription.

Parliamentary secretary Tonio Fenech recently accused various stakeholders of prescribing and dispending more expensive drugs to patients because there was more profit on them. What can a patient do to ensure that he or she is able to make an informed choice?

The use of generics now has to be seen in the context of their history. Generics were a four-letter word in the past when imports from all over the world offered no guarantee of quality and were often inferior - if not simply fakes.

The Medicines Authority was set up at the end of 2003 to comply with EU regulations and has since started the laborious process of registering all the medicines available in Malta. This led to recent controversy over the registration fee and cost of variations, as well as to a decrease in the number of medicines available.

There are 24,000 different drugs available in Europe but so far only 2,300 applications for local registration have been filed - mostly because of the stringent registration procedure.

And yet the mistrust of generics lingers. One pharmacist said that tourists often opted for the generic products when offered both while the Maltese viewed this with disdain - and it is not always because of brand snobbery.

The CEO of the Medicines Authority, Patricia Vella, realises that it will be an uphill struggle.

"Registration has cut out the risk of inferior quality," she said. "To register a product we have to be convinced that it is bioequivalent and that it is of the same quality.

"Our role is to be impartial so we would not promote generics any more than we would promote any branded product," she said.

"However, we would be all in favour of objective campaigns aimed at making the patient aware of their options."

Dr Vella, who also advises the government on policy, said that Malta is in favour of generics.

"There is nothing in Malta's legislation that in any way hinders or deters generics - if anything, it is easier for generics as the registration procedure does not require the dossier of the original patented drug," Dr Vella said.

If it is not legislation, then what is the bottleneck? Is it the way that doctors prescribe or that pharmacists dispense?

In the public health service, doctors must prescribe a drug using the international non-proprietary name (INN) for the active ingredient and not a particular brand. Government dispensaries automatically offer generics when available while its own medicines are bought by tender and generics tend to be cheaper.

In the private sector, the doctor is free to prescribe as he sees fit, however, the pharmacist - as a professional - can offer another brand or a generic unless the doctor specifically notes on the prescription that no substitution is allowed.

The president of the Chamber of Pharmacists Marianne Sant Fournier said that pharmacists often offered various options as it was good customer care but one patient, who asked not to be named, laughed out loud at this.

"I specifically asked for a generic and was told by the pharmacy that it was not as good. I walked out of that pharmacy and went from one pharmacy to another until I found what I wanted," he said.

Is the behaviour of doctors or pharmacists being influenced by drug companies? MAM secretary general Martin Balzan disagrees totally that prescribing is influenced in any way by incentives from drug companies.

"There are stringent controls on what incentives can be offered to doctors. For example, the trend now is for pharmaceutical companies to sponsor associations or activities rather than individuals. There are very strict parameters on what is allowed, including educational conferences. Even participation in clinical trials has to be very transparent - although not many are done in Malta.

"And don't forget that the manufacturers of generics can also offer incentives within the parameters," he said.

"It is not ethical for a doctor to promote one company's products over another," he said again and again.

Wasn't prescribing a brand discriminating against a generic one? Surely the best way to avoid promoting one company rather than another would be to prescribe by INN and to then let the patient see what was on offer at the pharmacy?

Dr Balzan did not answer directly: "Most doctors in private practice do tell the patient what is available - if they ask."

He also raised concern as to whether higher use of generics might pose a threat to the manufacturers of branded products.

"Globalisation has already led to a reduction in the number of pharmaceutical companies and of the existing ones, very few actually do research. People forget that new products are not always successful and the cost of all the research has to be recouped during the patent life of the successful products. Generics can pose a threat to this research," Dr Balzan said.

Could these arguments be justified when Glaxo Smith Kline announced profits in 2005 of £6 billion?

"I don't want to go into that," Dr Balzan said.

"There is no doubt that generics provide competition and ensure sustainability of health care, especially in developing countries. But there is no doubt that the cost of research pushes up the price of new drugs."

What about doctors in health centres? Shouldn't they follow government guidelines and prescribe by INN and not by brand - at least as a general rule?

"They should prescribe by INN, but I will stop there," he said, declining to comment on whether "should" translated to "did".

Dr Balzan thinks that doctors are far more sensitive to the cost of the medicines they prescribe than people realise.

"I think that doctors are very aware of their patients' social context," he said.

So does their prescribing depend on how affluent their patients looked?

"No," he bristled. "Do not turn what I said into a negative thing. I said that they are very aware of the impact of the cost of medicines. Let us not forget that a doctor wants his patient to get better.

"I do not think that the problem is as big as you are making it out to be. The WHO survey on Malta found that drug costs are actually relatively low in Malta given the level of health care. This must mean that doctors are actually quite cautious in their prescribing."

The MAM does not have a stand on the prescribing of generics.

"We follow international guidelines which state that the doctor should give independent advice and guide the patient as the best drug is not necessarily the most cost effective one."

The onus seems to be on the patient to demand better information from health care providers, rather than silently accepting what they are told. It will not be easy. Patients tend to feel overawed by doctors and would rarely dare to second-guess them.

"Perhaps once things are settled in the sector and we can see what products are available, we might see a change," Dr Vella said.

International study findings

A study carried out in April 2006 by the Research Centre for Pharmaceutical Care and Pharmaco-Economics in Belgium on generic medicines in Europe found that generics could represent cost savings of up to 80 per cent on the price of branded originator medicines.

"In this way, generic medicine supports the sustainability of health care provision and contributes to controlling pharmaceutical expenditure," the executive summary says.

"... Savings on the pharmaceutical budget in turn enables government to reimburse newer, more expensive medicines."

The use of generics varies widely in Europe, with Poland at the top of the countries surveyed with 84.7 per cent by volume, and Italy towards the bottom with just 4.5 per cent by volume.

Its general recommendation on boosting generic use favoured a multi-pronged approach:

"Policy intervention is required to develop a competitive generic medicines market. A generic medicines policy requires both supply-side measures (pricing and reimbursement) and demand-side measures (incentives for physicians, pharmacists, patients). Different policy measures need to reinforce each other and be part of a coherent generic medicines policy.

"More emphasis needs to be placed on convincing physicians, pharmacists and patients of the bio-equivalence of generic and originator medicines. This entails providing actors with information about the quality, safety and efficacy of generic medicines. National medicine agencies can play a role by periodically publishing lists of all active ingredients for which generic medicines have been approved by regulatory authorities."

Even mature markets can make savings by promoting further generic use. The study found that for the top 10 drugs, generic substitution could save between 21 and 48 per cent of expenditure on those items.

Leading by example

When it comes to generics, the government is leading by example. The Government Pharmaceutical Services purchases 10,000 different items every year, 2,000 of which are drugs, the rest being things like disposables, X-ray films and diagnostic materials.

Of those 2,000, generics account for 60 per cent.

"Most of the tablets, creams and so on are generic," GPS head Anna Debattista said. "The percentage is lower for other types of drugs such as injectables where there are not as many generics available.

"The percentage fluctuates as we procure by tender and it does - albeit rarely - happen that originator products cost less than generics."

The government has set aside Lm21.26 million for pharmaceutical supplies for 2006 (with an additional Lm2 million earmarked by the pandemic flu response). Of this, 66 per cent is spent on drugs (Lm14 million), a percentage that is growing year on year as people become more health conscious and there is more medical intervention.

"Having local generic companies here is a big plus," she said. "Last year, local companies started to supply products with very positive results. We are very happy with the quality and of course, it is very good from the point of view of delivery."

The impact on the bottom line is also positive. It saved Lm300,000 on a year's supply of a drug called amlodipine, used in treatment of high blood pressure and angina, by switching to a generic that cost 62 per cent less. It saved a further Lm306,000 on paroxetine, an anti-depressant, by switching to a generic that cost 51 per cent less.

"The savings mount up when you are talking about four million tablets and two million tablets a year for amlodipine and paroxetine respectively. And those are the figures for just two products.

"The registration system through the Medicines Authority has been a great support as we are convinced of the quality of the supplies," Ms Debattista said.

"The levels of generic use in the public system is comparatively high internationally but we expect it to get higher still. Patients who use generics without problems in the public health system are more open to using them when they buy drugs privately.

"We are already seeing more generics being registered in the private sector but it is up to the pharmacists and doctors to tell patients that the same active ingredients are used in generics. As long as we are assured of the safety, quality and efficacy of the medicine, there is no reason why patients should not be informed about the choice when there is such a difference in cost."

An indirect problem

Dr Balzan is very concerned by the reduction in the number of drugs now available in Malta, saying that GPs were the hardest hit.

When registration was introduced locally, applications were not submitted for the registration of a number of drugs then available on the market. In order to ensure that supplies were not disrupted, the government set up a qualified licence list, which exempts the registration procedure.

"Many of these items were slow moving. We were very disappointed that so many medicines were not going to be available." The list has grown to over 400 items.

This brings with it problems of its own. As the licence is not granted in the name of the manufacturer (known as the marketing authorisation holder), who is legally liable for a drug prescribed from the list?

The MAM has been receiving a number of anxious calls from doctors who are reluctant to shoulder the responsibility.

"We have not yet found a solution to this," Dr Balzan said.

Sectoral interests

Medicines are big business. The annual bill in Malta is around Lm50 million, Lm21 million of which comes from the public sector. The Medicines Authority unfortunately gets very little feedback from distributors and pharmacies on sales, even when it asks, making it hard to analyse the sector.

The EU has been unable to break through sectoral interests. The ideal would be to have mutual recognition so that a drug approved by the authority of one country would be automatically approved by all EU authorities. This so-called mutual recognition procedure has only been applied to 90 drugs in the EU so far.