Editorial

For a drug to be developed, tested and launched, it must undergo a lengthy and rigorous process that is also costly for drug companies. This outlay is recouped through selling prices that are higher than the production costs and the revenue covers years of research and development, costs incurred in proving safety, expenses connected to marketing and transport and the funding of research into the many compounds that, ultimately, fail to qualify as useful drugs.

Once a drug’s patent expires (up to 17 years), it may be manufactured by other companies. Generic, according to the US Food and Drug Administration, means “identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use”. Such drugs cost far less than their branded (or “innovator”) progenitors and this is one potential way for patients to contain spiralling health-care costs.

Are there differences between generic and branded drugs? Yes, there are or, at least, there can be.

Firstly, not all branded drugs have generic equivalents. Naturally, recently developed drugs are still patented. Moreover, in the above definition, “bioequivalent” means only the active ingredient/s need/s to be the same. Thus, the generic version may be of a different colour, a different shape, have a different taste or contain inactive ingredients that are different.

There have been problems reported by people who changed from a branded drug to its generic, and vice versa, and, in most cases, the problems seem to stem from the variation in the inactive ingredients while others could be caused by the actual amount of active ingredient.

Regulations stipulate that generic drugs must be given new names. The ideal way to be sure a patient is getting exactly the drug s/he needs, branded or generic, is to consult one’s doctor or the Medicines Authority (see opposite page). When the doctor prescribes a drug, it is perfectly reasonable to ask whether this is an original and, therefore, expensive drug, and if there is a generic equivalent.

Matters are compounded by studies showing the Maltese consumer is paying about 40 per cent more than the average price for medicinal products in the European Union. The government has been adamant that medicine prices must be “just and reasonable” and has even warned it was ready to fix the prices of products selling above the European average and make them mandatory by law if stakeholders did not cooperate. There was some resistance but, thanks to the Administration’s efforts and determination, the list of medicine products that have dropped in price, both branded and generic, continued to get longer.

Retail pharmacies make a profit of about 16 per cent on all medicine sold. The contention that a reasonable cut in prices is tantamount to the government “attacking the viability of pharmacies” must surely be grossly exaggerated. Such decreases may only encourage compliance with treatment, which, if excessively expensive, risks leading patients to simply doing without.

It has also been claimed pharmacies are subsidising over 20 per cent of the Pharmacy of Your Choice scheme by providing services not factored in as costs. Still, both this and the clampdown on medicine prices found to be above EU average have not caused any of the 300 pending applications for new pharmacies to be withdrawn. One is free to draw one’s own conclusions.