Govt. must implement Essential Drugs List to ensure availability of drugs at affordable prices

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Govt. must implement Essential Drugs
List to ensure availability of drugs
at affordable prices
Since 1999, around 160 countries of the world
have adopted the Essential Drugs concept
and prepared their Essential Drugs lists
Dr. Inamul Haq*

A news has recently appeared in Daily DAWN on September 2019 which states that “Ministry moves against unethical marketing of drugs”. The move against alleged alliance of doctors and companies to safeguard the interests of patients as stated by the ministry’s media coordinator is an old story repeated after every change in the bureaucracy and Government. To continue this story, Special Assistant to the Prime Minister on Health Services, Dr. Zafar Mirza, tweeted that he held a brainstorming meeting to develop a strategy to address an unholy alliance between the medical professionals and pharma industry. These two entities are allegedly indulging in unethical practices at the cost of patients, resulting in high prices and irrational use of medicines as reported. He further tweeted that after a very enlightened discussion the stakeholders will soon be developing an action plan to check unethical marketing of medicines.

It may be mentioned that the issues of high prices of drugs and unholy alliance between the medical professionals and pharma industry have been repeatedly debated by the governments, the stakeholders, and the patients during the last about five decades without any outcome.

In the meantime, in a period of just about four years between 2015 and 2019, the National Ministry of Health and DRAP officially notified in the press of three Drug-Pricing Policies that provided the basis of mechanism to control high prices and even the formula for price fixation (MRP). Unfortunately, these have failed to solve the pricing control issue to-date due to their non-implementation. Apart from the pricing policies, the National Drug and Health Policies published in 1996 and 1997 respectively by the Ministry of Health with the primary objective of making available the essential, life-saving, safe, and standard quality drugs at reasonable prices met the same fate.

Ultimately, in view of these failures of the Ministry of Health Services and DRAP, the then Wafaqi Mohtasib, took the initiative in 2016, on the direction of the government and in the public interest, to solve the issue of availability of the life-saving essential drugs at affordable prices to the helpless patients; which is their constitutional right. An expert committee of all the stakeholders comprising of 12 members, including representatives of the Health Ministry and DRAP, was assigned the job of implementing the globally adopted WHO Essential Drugs scheme of availability of standard quality drugs at affordable prices to the patients. The committee, after deliberations of over one year, prepared and submitted a report to the then President of Pakistan who approved it in 2017 for implementation by the Ministry of Health services and DRAP. It has been about two years now that the fate of this report is still not known. Hundreds of copies of this report were published in booklet form for distribution to the stakeholders and heads of the concerned institutions at a huge cost.

As regards to the irrational use of medicines earlier, the committee of experts constituted by the then President of Pakistan in 1987 under the chairmanship of Lt. Gen. M. Z. K. Mohiuddin – the then Director Pakistan Medical Research Council, recommended to place the drugs under the following categories to ensure the availability of safe and effective drugs. They drafted this proposal after a thorough review of the Pakistan National Formulary 1981:

  1. Harmful drugs to be destroyed within two months.
  2. Non-effective drugs to be withdrawn in four months.
  3. Certain ingredients needed deletion within six months.
  4. Drugs with questionable effectiveness to be reviewed within twelve months.

Thus, 344 useless drugs, out of 7,045 were to be deleted immediately while another 1,570 drugs were to be reviewed for deletion within the above timeframe.The report of the committee comprising 12 volumes, prepared after deliberations of about 1.5 years and involving huge financial and human resources, is currently collecting dust somewhere in the shelves of the Ministry of Health and has never seen the light of day.

The Sixth and Seventh Five Year Plans clearly laid down to rationalize the number of drugs in order to eliminate ineffective and inappropriate drugs by minimization of imitation of drugs, elimination of highly toxic drugs, and refrain the manufacturers from producing new and trivial drugs. However, contrary to this, the number of formulations registered by the Board are rising in each meeting. The rationalized Essential Drugs list recommended in Sixth Plan was supposed to contain 600 to 1000 drugs considered sufficient for all levels of healthcare.

It would have been proper, rather mandatory, to regularly review and limit the increasing list of registered drugs over the last three decades, especially after the enforcement of DRAP Act 2012, when the list of registered drugs had swelled up to about one lac drugs. An analysis of the list will reveal that it comprises mostly non-essential, obsolete, and therapeutically useless drugs, for instance, hundreds of multi-vitamins, compound cough formulations, and third generation antibiotics that may be the cause of antibiotic resistance. The review was felt necessary when the number of registered drugs in Pakistan National Formulary 1981 rose to 6,000 dosage forms, up from about 3,663 registered in 1977, which further increased from some 8,000 in 1988 to around 14,000 in few years, due to liberal registration policy.

The Drug Policy 1996 lays down that all irrational, unsafe, and obsolete formulations and combinations must be de-registered. It was only in 1985 that 78 registered drugs under Drugs Act were de-registered by the Registration Board at that time in the public interest, as these were considered irrational, unsafe and obsolete under the Drugs Act 1976.

It is painful to notice that according to rough estimates, 50%-60% of population in Pakistan has no access to even essential life-saving drugs whereas the market is flooded with all types of expensive, irrational, and non-essential drugs of doubtful efficacy and even obsolete drugs. Since these drugs/formulations are based on imported Active Pharmaceutical Ingredients, this contributes significantly towards waste of valuable foreign exchange resources.

Over the last decade or so, a number of national and international seminars, workshops, conferences, meetings etc. held at the cost of huge expenditure to introduce the essential drugs list as recommended by the WHO, has failed to bring about any result. The essential drug list prepared in 1987 with the participation of the WHO experts and published in 1988 contained about 263 basic drugs (368 dosage forms) similar to the WHO essential drug list for primary health care.

The above brief shows that not only the drug pricing policies and vital related official reports, but also the legal provisions provided in the Drugs Act 1976 and the DRAP Act 2012 about price control, quality, and safety of drugs, are being ignored. The record will bear enough evidence to show that almost the same policies and legal framework were being implemented to successfully control the high drug prices and their availability in the past without any crisis by the then properly qualified personnel in 1960’s and 1970’s in the absence of DRAP Act 2012 and Drugs Act 1976.

In spite of these failures and non-implementation of policies and mandatory legal provisions of Drugs Act 1976 and DRAP Act 2012, we are still talking of introducing another “National Medicine Policy” that will ensure an access to essential medicines at affordable prices to provide a long term solution seems ironic. In this respect, a tweet of the Special Assistant to the Prime Minister on Health Services, Dr. Zafar Mirza, appearing in Dawn of Sept 19, 2019 that he held a “brainstorming meeting” to check unethical practices resulting in higher prices of drugs at the cost of patients is astonishing indeed.

While we go on experimenting with more pricing policies and holding meetings and seminars ignoring the ground realities, the miseries of the helpless patients are compounding due to non-availability, shortage and high prices of quality essential drugs. Taking notice of this situation, the Transparency International had to intervene in public interest by asking the government for clarification on increase in the drug prices, saying that DRAP’s response to their complaint did not adequately explain revision of pricing regulators.

The reasons of the lack of ability to control the Drug prices, in my humble opinion, during the last several decades are:

  1. Non-implementation of drug pricing control policies and drug laws
  2. Lack of political will
  3. Mismanagement
  4. Corruption
  5. Incompetency

Rather than continue holding meetings, seminars and conferences, the government and the experts in the field need to step up and take practical steps to resolve the situation. If some concrete and definitive measures are not undertaken immediately to resolve the drug pricing, availability, and quality issues, the situation is likely to worsen further resulting in deaths of the innocent patients due to unavailability of quality life-saving essential drugs. According to drug regulations, it is the function and responsibility of DRAP to develop, issue, adopt, and enforce the standards and guidelines so as to ensure safety, efficacy, and quality of therapeutic goods, and also to monitor and regulate the unethical marketing practices to ensure rational use of drugs at reasonable prices. It is pathetic indeed to learn from the above brief situation analysis about our failure to provide standard quality life-saving and quality drugs at affordable prices to our population due to the reasons listed, amongst several others, which were and still are beyond our control.

Keeping in view the above failures and under the prevailing circumstances when the government is keen to provide better healthcare to people, it would perhaps be advisable to adopt the already globally practiced WHO Essential Drugs scheme which was launched by WHO in 1981. This scheme was based on then concept that a restricted number of time-tested, safe, standard, and quality essential drugs should satisfy the health needs of majority of the population of a country, and must be available in appropriate quantities and dosage forms at affordable prices at all times. This concept emerged in 1977 when WHO published a model list of reference Essential Drugs. ALMA ATTA declaration of Pharmacy Health Care introduced in 1978 identified provision of Essential Drugs as one of the eight elements of Primary Health care.

Kenya was the first country to adopt and implement this scheme in 1981. In June 1982, Bangladesh introduced a National Drug Policy and Drug Ordinance in accordance with WHO guidelines to implement this scheme, which is quite successful to date. Since 1999, around 160 countries of the world have adopted the Essential Drugs concept and prepared their Essential Drugs lists, which are supported by their National Drugs Policies. Pakistan, where Pharmaceuticals is one of the biggest industries of the country have failed to implement this scheme even after its approval by the Ex. President of Pakistan in May 2017 and also after announcement of National Drug Policy 1986 and finalization of Essential Drugs list on WHO guidelines. In fact, the then WHO coordinator in the Ministry of Health and WHO mutually agreed upon a collaborative program on Essential Drugs and a plan of operation 1988-89 was drawn in July 1989. This plan was not followed upon due to changes in the Ministry except for publishing a Hospital Formulary containing 270 Essential Drugs as per WHO guidelines.

It would be in the best interest of the nation and particularly of the patients to implement the already worked out WHO Essential Drugs scheme that was approved in 2017. This scheme also provides complete methodology and even the roadmap on its implementation.

As regards other Drug Regulatory and Production issues such as monitoring of side effects and use of unsafe medicines etc., the DRAP Act 2012, which was established for effective enforcement of Drugs Act 1976, provides thirteen sections. Each of these sections are headed by a Director, with their functions and responsibilities defined to deal with safety, efficacy, quality, and all related issues to safeguard Public Health. This Act also covers the manufacture, sale, and distribution of Alternative medicines (Act 2014). The need of the time is to implement these rules-and-regulations and policies in letter and spirit to protect the public from possible health hazards of the medicines, which is the main function and responsibility of DRAP and Ministry of Health Services.

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