Equivalent medicines fulfill a social role, providing low-cost, high-quality medicines. The economic resources freed-up through savings on pharmaceutical products can be used to acknowledge the high costs of research borne by the pharmaceutical companies.
In Norway, however, the move from original medicines to equivalent ones is happening slowly, due in part to people’s skepticism, according to pharmacy student Turgay Bardakci. The culture of equivalent medicines has yet to become widespread among patients.
A Real Relief for Welfare System
With healthcare costs continuing to rise, generic drugs are looking more attractive than ever. The prospect of getting the same drug at a lower cost is tempting to anyone with a large drug bill — patient or the State. The savings are massive: To date, the social security system of the Norwegian Medicines Agency saves two billion annually thanks to the people choosing the cheapest medicine, which are suggested at pharmacies. Pharmacy Student at University of Oslo, Bardakci believes that even more money can be spared by educating people about the generic drugs.
Currently, pharmacists are responsible for most of the switches from brand to generic drugs. In Vitus Apotek, where Bardakci works, regulations specify which drugs and brands may be substituted — that is, with patient or prescriber consent. So they spend a lot of time speaking with patients about generic drugs. The Pharmacy will offer another medicine with a generic name other than what your doctor has prescribed if there is an equal and affordable alternative.
Yet Brand Matters
Misconceptions are common, ranging from manufacturing standards (“they’re weaker!”) to efficacy (“the drugs don’t work!”).
The pharmacy may only offer such a switch when NoMA guarantee that drugs have the same medical effect and are as good as their branded counterparts.
He notes that one of three customers are skeptical about buying these medicines. Some choose the most expensive product, even if there’s several hundred NOK difference in price.
– Many are reluctant to buy products that have a different name than the doctor writes on the prescription, says Bardakci stressing that there is no difference in the components of synonym preparations or Generics of these alternative brands.
He says only ingredients that add color and flavor can be different and there is no need to be skeptical about their safety because, the pharmacy can only offer a medicine approved by the Norwegian Medicines Agency.
Bardakci also calls for doctors to explain to their patients that there is no risk in choosing a cheaper alternative.
What is a generic drug?
What is referred to as a “generic” drug may vary by country, and be influenced by both medical practice and by regulatory requirements. The most common definition is that used by the World Health Organization:
“A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights.”
Although they may not be associated with a particular company, generic drugs are subject to the regulations of the governments of countries where they are dispensed. Generic drugs are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug.
A generic drug must contain the same active ingredients as the original formulation. According to the Norwegian Medicines Agency, generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered identical in dose, strength, route of administration, safety, efficacy, and intended use.
In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US and many other countries, drug patents give 20 years of protection, but they are applied for before clinical trials begin, so the “effective” life of a drug patent tends to be between seven and 12 years.
Economics of Generic Drugs
Generic drugs are usually sold for significantly lower prices than their branded equivalents. One reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies incur fewer costs in creating generic drugs (only the cost to manufacture, rather than the entire cost of development and testing) and are therefore able to maintain profitability at a lower price. The prices are low enough for users in many less-prosperous countries to afford them.
Generic manufacturers do not incur the cost of drug discovery. Sometimes, reverse-engineering is used to develop bioequivalent versions to existing drugs. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company.