The Dilemma of a Minister

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By Duncan Fernando :

The draft regulations of the proposed National Drugs, Cosmetics and Devices Authority Act  is nothing but a joke. It is the same  Dracula  presented  with more teeth in a different cloak to benefit the mafia. This is not what the public anticipated

The Minister of Health has gone on record as saying that the ``Health Ministry is surrounded by four types of racketeers. They are multinational milk powder companies, multinational drug companies, multinational cigarette and alcohol companies and corrupt officials bribed by those multinational companies. The ministry can face this challenge successfully only if all support it - especially the media.”  According to Minister Sirisena, the ministry is engaged in a significant amount of work to protect the public from those four racketeers. CDN - 12.08.13

Corrupt officials in the ministry are an unfortunate legacy inherited by the ministry.  Solving the problem of corruption is vested in state apparatuses.  The Ministry of Health is no exception when it comes to corruption. The appointment of a Secretary from the SLAS recently confirms the first line of treatment to this scourge. A structural change in the Ministry is an imperative to eliminate corruption.

The most controversial issue today with the Ministry of Health is not preventive and curative care but procurement of supplies and implementation of regulatory functions. Human Resource conflicts at various levels in the organisation add to the woes. Both are incurable ailments that have drawn the attention of the general public. A country that controlled malaria, filaria, cholera, smallpox and other tropical diseases is today struggling to control Dengue as the medical administrators are grappling with other issues.  Most recently,  on July 30, the public were able to witness how doctors behaved in trying to  solve one of their issues
Private sector, hospitals are managed by shareholders. medical professionals are engaged mainly in curative services for which they are compensated. Medical administrators do not manage the shareholders.

Implementing the Drug Act & Food Act in 1980 under Ministry of Health led to the development of `Obesity` among Health Administrators.  Non communicable diseases such as diabetes, Ischemic heart disease, hypertension and cancer are on the increase, creating a huge market  for healthcare  needs.  We face the controversy of CKDU which is costing the government millions. Under proper preventive care an effective awareness campaign would arrest this trend and save billions in foreign exchange.

The drug utilization process should be vested under an `independent authority` outside the purview of the Ministry of Health to sort out the existing mess and to evolve a drug delivery system to meet national needs.

In 1972, on the recommendations of the Bibile/Wickremasinghe report, the State Pharmaceuticals Corporation (SPC) was incorporated by an Act of Parliament.   It functioned under the Ministry of Industries and Scientific Affairs. It  serviced  national  needs by providing essential drugs at affordable prices. This culture changed in the early eighties with the open economy.

Today the State Pharmaceuticals Corporation under the Ministry of Health, is marketing a brand of paracetamol imported from India through pharmacies @ Rs. 1.00 per tablet. A tablet of this drug can be easily sold at 50 cents for the benefit of the consumer. This inflated price defeats the very objectives of the SPC. The infection of corruption that prevails has developed into chronic levels.

The draft regulations of the proposed National Drugs, Cosmetics and Devices Authority Act  is nothing but a joke. It is the same  Dracula  presented  with more teeth in a different cloak to benefit the mafia. This is not what the public anticipated. It is what the mafia has manipulated. Prof Lal Jayakody, a recognized academic had recently focused on where the devil is.

We have several Medical Faculties and a Post Graduate Institute of Medicine. These bodies train medical professionals.  Pharmacologists play a key role in inculcating the ethics of `drug usage in clinical practice` to budding professionals. Their expert  advice  is crucial in devising a National Drugs Policy. The Pharmacists are there to manage logistics till a patient receives a drug. They are professionals in this field. Sri Lanka Pharmaceutical Society is a professional body. Their views must also be taken into account.

According to the WHO, the process of ``drug utilization`` is defined as, `` marketing, distribution, prescription and use of drugs in a society with special emphasis on the resulting medical, social and economic consequences

The people are baffled as to why the Medical Administrators cannot implement regulations that are in effect now. For example CDDA Gazette No 722/2 dated 06.07.1992 contains regulations which are suppressed to the detriment of the people. It had been swept under the carpet for a long time. The Minister may not be aware of this.

An Independent Drugs Authority at National level is an imperative to oversee the movement of Chemical and Biochemical substances that are used in medicine, agriculture and industries. These substances bear an end result in humans. The famous Food and Drug Administration (FDA) of USA is a forerunner. It imposes stringent controls on usage of these substances. Under these circumstances the proposed Cosmetics, Devises and Drugs Authority Act should be reviewed or made redundant.

Under a restructured ministry, only the task of healthcare that is preventive and curative should be devolved to the Healthcare system. Even the Medical Research Institute should be made an autonomous body. At present the Universities provide doctors and other professionals to man healthcare services. Similarly, other institutions can provide  services such as drugs, devices, fixtures, fittings, furniture and buildings to provide healthcare. For any shortcomings, the doctors can aim their guns towards these supply services. This is one way of breaking the nexus of corruption in the Ministry.

The Ministry of Health should deliver a National Healthcare Policy including all currently available healthcare facilities in our country, such as allopathic medicine, indigenous medicine - ayurvedha, homeopathy, unani, sidha and holistic medicine. Healthcare covers all these disciplines.  

In many developed countries including USA, Germany, Japan, etc.. research and development is based on this foundation. Our Ministry is dominated by stooges of western medical culture backed by MNCs. They deprive the country of utilizing natural resources for the benefit of mankind. On the other hand they engage in bio-piracy to do research on our naturally occurring substances.

If the proposed National Drugs, Cosmetics and Devices Authority becomes statute under the Director General of Health Services, it will destroy our entire heritage.

The debate on this issue is not complete if the pharma-industry,  a major stakeholder is not drawn in. They are primarily profit driven.  R & D is secondary. 

Internationally it is a well known fact  that  pharma-industry is highly profitable and is growing at a tremendous  rate.  When bribery and corruption is discussed,  the giver plays a superior role to procure business. That is (unethical) business.  The bribe component is built in the end user price.  Imports have to be over invoiced to include the bribe component. This practice is rampant in growing markets. The latest is the multimillion dollar corruption scandal by GSK in China.

The subject of advertising and  brand promotion direct to medical profession is a thing of the past. In a country where IT and communication facilities are advanced, any medical professional can access information on the internet or contact a peer for advice over the phone. Besides they have their continuous medical education programmes conducted by relevant specialist associations.

The mechanism of price regulation adopted by Consumer Affairs Authority has no positive impact on consumers. The CIF prices can be manipulated to maximize profits.  In the alternative, if Import Duty is enhanced the tendency would be for under invoicing. It will have a direct bearing on price, leading to a level playing ground. It will also generate income to state coffers.

Corruption is an integral component of a free market economy. When corruption is an endemic infection at national level, not confined to the ministry of Health alone, finding a remedy is beyond imagination. Therefore to eliminate corruption in the Ministry of Health is indeed a dilemma for the Minister. However, he would be able to minimise corruption to a great  extent if he can resort to a structural change in the ministry as suggested earlier, leaving health professionals to take care of only preventive and curative  functions. The nation as a whole will support this move.