Going generic and bringing health to all

By Dzulkifli Abdul Razak

A COUPLE of years ago, the Government put forward its intention to implement the National Essential Drug List (NEDL). Apart of streamlining drug use in the country for both the public and private sectors, it is also proven as a useful strategy in cost of drug use. The intention is a pro-active step, especially today.

What with the recent announcement that the Government is seeking a RM78 million allocation from the World Bank to cope with the rising cost of drugs and the increased number of patients (NST, June 10), the implementation of NEDL could be an effective strategy to ensure that the money is optimally use in the short term.

In the long term, NEDL can help stimulate the local pharmaceutical industry and reduce foreign dependency. Malaysia's drug imports are said to be as high as 75 per cent.

By definition Essential Drugs are:

  • those that satisfy the health care needs of the majority of the population;
  • they should, therefore, be available at all times in adequate amounts;
  • in the appropriate dosage forms;
  • at reasonable (affordable) price; and,
  • meeting the criteria of quality, safe and efficacy.

While Malaysia has done well in adopting a number of measures to regulate the pharmaceutical sector especially with respect to quality, safety and efficacy, it is yet to address the issue on equity of access effectively.

In this regard, the Essential Drugs Concept remains a cornerstone in ensuring the equity of access by the provision of essential drugs. It is a core component of the strategy - agreed by the World Health Organisation and all its member countries, including Malaysia - for bringing about health for all.

The urgency of the situation is compounded by the fact that the pharmaceutical market is different from those dealing with non-pharmaceutical consumer goods, and cost control is a tricky question.

For instance, a consumer generally does not do the product selection (in this case, drugs) like other goods. The choice of drugs is made by a health professional. Invariably, the prescriber is not the one who is paying for the conduct selected.

The prescriber in fact will tend to benefit from the choice made. Even if the consumer selects the product (as in over-the-counter items), usually comparison based on value for money is not critically made in terms of quality, efficacy and even safety.

There is evidence that healthcare professionals and workers are in short supply or otherwise insufficiently trained to make full assessment of drugs, and depend largely on the claims of the seller. Even then only the "positive" aspects are stressed.

Above all, fear of illness can create irrational and costly demands leading to "drug misadventuring".

Globally, as of 1997, more than 140 countries have adopted their own Essential Drug Lists.

Apart from the national Essential Drug Lists, nearly 100 countries and numerous NGOs have complemented their lists with formularies, standard treatment guidelines and other manuals and practical guides as invaluable tools for rationalising pharmaceutical consumption and expenditures.

WHO initiated in 1977 the Model List of Essential Drugs which was subsequently revised every two years or so based on sound scientific, clinical, and economic principles. The Model List now available is the 10th edition, revised in December 1997.

At the International Seminar on Essential Drugs held in Penang, last September, a tentative list of 450 drugs was announced. Now is the time to formalise the NEDL and implement it as soon as possible.

Closely related to the concept of Essential Drugs is the use of generics. This is because in the Model List, WHO recommends the use of the international non-propriety name for each drug. This is the shortened scientific name based on the active ingredient used, commonly known as the "generic" name.

In fact, a large proportion of the items recommended in the WHO Model List are off patents. They, therefore, can be manufactured freely under such name, and thus the price can be very competitive relative to the branded products. In the final analysis, it makes implementation of an essential drugs strategy more feasible and fully compatible in giving greater access to essential drugs.

All these augurs well for Malaysia in the attempt to offset the currency problems, and strategise towards self-reliance on drug supply.

The Health Minister has been quoted as encouraging doctors to use generics as a cost-saving measure (NST, Jan 17). This is in line with global trends. Even in countries with strong pharmaceutical industries (like Britain), there is a significant market penetration by generics.

For example, in Germany, Denmark, the United States, and the Netherlands, pharmacists are even allowed to substitute generic drugs for branded ones. Although in Britain, generic substitution is generally opposed by the industry, the use of generics has been reported to grow from 16 per cent of prescriptions in 1977 to 54 per cent in 1994.

Generic substitution may also assist in reducing drug spending, though limited only to non-patented products. In the US too there has been a steady growth in the use of low-cost pharmaceutically equivalent products.

In fact, in 1971, the American Pharmaceutical Association, in a change of position, called for a repeal of the anti-substitution laws which were mainly passed in the 1950s. Today, in the US, generic dispensing too was reported to have grown from about 18 per cent of new prescriptions in 1984 to almost 40 per cent in 1994.

During the 1980s, branded drug prices rose sharply relative to inflation and in response to this, many US states not only repealed laws prohibiting generics substitution, but promulgated measures which encouraged such dispensing.

The US Federal Drug Adminstration has been consistently supportive of the use of generics. In February this year, the FDA was reported to have defended that generic drugs were as good as the branded ones against the industry trying to fend off cheaper alternatives approved by the agency.

The FDA also examined more than 400 samples of 24 brand-name and generic drugs, and the generics met "established standards of purity and quality". It stood by the interchangeability of the product.

We must now recognise the potential that generic drugs can contribute to healthcare development by improving affordability, availability of information, increasing choice and helping rationalise both selection and use of pharmaceuticals, thereby further easing the current economic situation.

The Health Minister's call for NEDL and to prescribe generic drugs instead of branded ones or patent medicines even before the turmoil, and again recently (NST, Jan 17), must be taken seriously. It adds merit to the strategy of going generics in general, and specifically the NEDL. Otherwise, branded drugs will perpetually be perceived as "better quality" drugs.

As such, laymen and professionals alike will continue to patronise them making the search for a long-term solution to question of equity, arduous and more difficult. We may then to borrow again for our pharmaceutical needs.

The writer is the director of the National Poison Centre, and head of WHO collaborating centre for drug information at Universiti Sains Malaysia.

The New Straits Times
Thursday, June 25, 1998