Monday, January 18, 2010

Malaysian Insider: Generic drugs — setting the record straight

Generic drugs — setting the record straight

Generic drugs could cut your medication bills up to 90 per cent. — Reuters pic

Malaysian Insider; JAN 18 — Are you aware that Malaysian pharmaceutical manufacturers have developed and launched generic drugs using their own brands and these generic drugs are meeting at least 65 per cent of the domestic prescription drug demand?

Did you also know that about 80 per cent of essential drugs in Malaysia have generic substitutes, including the 20 most-used medications for conditions such as hypertension, cholesterol control and diabetes, to name a few?

A recent study by a group at Universiti Sains Malaysia and published in the Journal of Generic Medicines showed that the use of generic drugs could save patients up to 90 per cent in their total medication costs.  If such substantial savings can be obtained, why aren’t there more Malaysians on generic drugs?

What is the difference between innovator drugs and generic drugs?

An innovator drug is the first drug of its kind to be discovered, developed and subsequently marketed by a pharmaceutical company.  When a new, effective and safe drug is discovered, it is common for the pharmaceutical company that discovered the new drug to apply for patent protection.

A patent protects the company by not allowing other drug companies to manufacture or market the patented drug until after the patent expires.  During the patent period, the drug is supplied exclusively by the innovator company and sold under the company’s trademarked name.  All new drugs have patent protection for a period of at least 20 years.

After the patent expires, generic versions of the drug can be developed and marketed.   Generic drugs manufacturers may market them under their own brands or under the drug’s chemical name, also known as the international non- proprietary name (INN).

However, before a generic drug can be marketed, drug regulatory agencies require that the generic drug should meet the same quality, safety, dosage and performance standards as the innovator drug.

In Malaysia, the Drug Control Authority (DCA) stringently regulates the quality, safety and efficacy of all drugs through production audits, import controls, marketing authorisation (registration), post marketing surveillance and sale of all pharmaceuticals. Malaysian pharmaceutical manufacturers are required to comply with the Code of Good Manufacturing Practices as laid out by the Malaysian DCA.

Malaysia, being a member of the International Pharmaceutical Inspection Cooperation/Scheme (PIC/S) since 2002, has helped to improve further the standard and quality of local generic drugs, over-the-counter and health supplements industries.  Malaysian generic drugs manufacturers must adhere to the strict European Union regulations and registration processes laid down by the PIC/S that require generic drugs produced to be thoroughly tested for safety and efficacy before they can be sold domestically and overseas.

Malaysian-made drugs are exported to more than 40 countries — a testimony to the quality, efficacy and safety of Malaysian-made pharmaceutical products and the international acceptance of Malaysian standards.

In line with Good Manufacturing Practices (GMP), DCA auditors conduct random and periodic on-site inspections to ensure that all manufacturing practices, including Good Laboratory Practices (GLP) and Good Storage Practices (GSP), are in line with local and international regulations and standards.  For manufacturers that export their generic drugs, their facilities are also subject to GMP audits by drug regulatory inspectors of the respective importing countries.

“A significant number of consumers, including some healthcare providers, still hold the perception that locally-manufactured generic medicines are not similar in efficacy and quality to innovator drugs. This is totally inaccurate. As a matter of fact, it is common for a local pharmaceutical manufacturer to produce both innovator drugs (under license from multinational drug companies) and generic drugs within the same facility,” said Jimmy Piong, President of the Malaysian Organisation of Pharmaceutical Industries (MOPI). “Many of these misconceptions are due to lack of awareness and understanding of generic drugs.”


Another common misconception is that generic drugs are not as efficacious and potent as innovator drugs.

Although the appearance of a generic drug may be different in shape, colour and size, it must, nevertheless, contain the same active ingredient as an innovator drug.

In addition, generic drug manufacturers conduct clinical efficacy trials such as bio-equivalence studies to establish efficacy. A bio-equivalence clinical efficacy trial study involves comparing a generic versus innovator drug in the same dosage under the same conditions on human subjects.  This clinical efficacy trial is conducted on human test subjects to prove that the generic and innovator drug work and act in the same way on all test patients.

In short, the clinical trial must show that the efficacy of the generic drug is exactly the same as the innovator counterpart.  When the generic and innovator drugs are interchanged or substituted, no significant difference in safety and efficacy should be observed.

If generic drugs are as good as innovator drugs, why do they cost less?

The cost of a drug can be divided simply but broadly into two components  — new drug discovery cost and manufacturing cost.  The main cost of an innovator drug company goes into the discovery of the drug, the ensuing clinical trials to determine the safety and efficacy of that newly discovered drug and aggressive marketing campaigns.

Generic drug companies focus principally on the manufacturing process which includes formulation development, bio-equivalence (BE) clinical efficacy studies, stability studies, quality control and assurance, and therefore the “discovery” cost component does not feature in the cost equation. This is ultimately reflected in the competitive pricing of generic drugs, a benefit that is passed on to consumers.

In a nutshell, the distinction between an innovator drug company and a generic drug company may be best explained in that the expertise of the innovator drug company is essentially in innovation and research of new drugs while the manufacturing processes are generally similar between generic and innovator manufacturers.

The decision to use generic medications has ultimately to be made in consultation with one’s doctor and/or specialist.  With their intimate knowledge of their patient’s medical history, they would be in the best position to offer appropriate advice.

Said Dr David Quek, President of the Malaysian Medical Association: “Most if not all doctors consider the well-being of their patients as the first and foremost consideration when prescribing any medications. Doctors consider first the need for the drug, the quality, the make, the evidence, and the requisite bioequivalence testing which gives the doctor the full confidence that the drug prescribed truly contains the medicine that it is supposed to have.

“Second, any drug used must be consistently produced in good manufacturing practice pharmaceutical factories. Given this assurance which must be borne out by rigorous safety, standards and dose testing, appropriate post-marketing surveillance and clinical use, doctors would prescribe any drug, be it a generic or a proprietary one.

“Most doctors would prescribe any drug which is considered safe, of assured quality and also efficacious, with price being a plus factor, especially for those who are price conscious. The use of any branded proprietary drug is governed mainly by the perceived greater quality control and testing, as well as the evidence-based research that has gone on to confirm the efficacy and potency of the drug concerned.”

Dr Quek added:  “In very serious illnesses however, many doctors believe that using a branded product may be superior because doctors would like to be sure that they have used the product which is assured of its quality and its purported effects.

“Doctors cannot afford to be wrong in their choice of any drug under such circumstances—so perception of generic drugs must be improved upon with greater emphasis on quality assurance measures.”

Dr Quek commented: “The use of generic drugs in Malaysia can be made more popular when medicines for more serious ailments are made to international standards of quality.

“The use of these drugs must be tempered with the confidence that these drugs are produced at a standard at par with branded ones. However, when innovator ‘branded’ drugs are used, these tend to be newer classes of drugs and are perceived to be more efficacious medicines. These are sometimes needed to treat illness which had failed using generic ones. Occasionally, these innovator drugs are easier to adhere to because of fewer adverse effects or easier dosing intervals.

“Generic drugs in Malaysia, need to be improved in terms of its quality, regularity of bioequivalence testing and standardisation, and its confidence level of acceptance before they can unequivocally be used without any reservations by all doctors.”

On the issue of price, Dr Quek said: “In the long run, any medicine that is affordable to most patients is critical in ensuring that patients can adhere to their therapy, especially for chronic ailments such as hypertension, diabetes, arthritis, heart disease or hyperlipidemia. It is of no use to use only a branded drug for a short period, and then stopping because of patient drop-out due to costs constraints. It is better to ensure that patients can afford whichever drug that is prescribed. Hence there is a great role to play for good quality generic drugs to ensure greater universal compliance with treatment."

“Generic drugs are important because they help to reduce the cost of prescription medications in any country, including Malaysia. In fact, most drugs used for family physicians or GPs, as well as most public healthcare facilities use predominantly generic drugs for many ailments.”

Piong of MOPI commented: “It is important for Malaysians to be aware of the options when it comes to their medicines.  Generic drugs do offer patients with accessible and affordable drugs.  They play an essential role in maintaining public health.  Consumers have the right to know and make an informed decision base on the correct information which is readily available from the family doctors and pharmacists”. — Malaysian Organisation of Pharmaceutical Industries (MOPI).

1 comment:

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