New laws will ensure better healthcare:

Quality and affordability, the hallmarks of new drugs policy

By Manjula FERNANDO

In an interview with the Sunday Observer, the Health Ministry's Additional Secretary of Medical Services Dr.Palitha Mahipala elaborated on the proposed new National Drugs Policy of the Government and the planned amendments to the Private Health Sector Regulatory Act which governs private hospitals. He asserted that the new laws would ensure a better healthcare system for the public while being alive to the latest developments in the industry including new drugs and vaccines.

Excerpts from the interview:

Q: Sri Lanka is a pioneer in pharmaceuticals regulation. Why haven't we been able to effect a proper drugs policy yet?

A: Sri Lanka has an existing drugs policy. It is a legal document. In the context of health sector development, Sri Lanka is a country quoted by international agencies as one of the best. Our immunization program and child and maternal care systems are among the finest in the world.

Traditionally we have a pluralistic kind of health sector in Sri Lanka.

With the invasion of the Portuguese the first hospital was built in 1552. Since then hospitals were built throughout the country. Not only in Sri Lanka, but all over the world, hospitals served as centres of segregation to prevent the spread of disease.

Historically there were three public health interventions, one isimprovement of sanitation, the other is vaccination and diseaseprevention that commenced with the small pox vaccination.

In SriLanka we give ten vaccines and most of these diseases by now are near elimination or already eliminated. The third one is the quarantine process to isolate patients with communicable diseases.

With the development of drugs, anaesthetics and surgery, the hospitals were able to offer better services to the people.

Then the hospitals assumed an important role in society. In the provision of curative care, drugs play an important role. Gradually vaccines and antibiotics were developed. That has encouraged the medical profession to provide comprehensive care to the people.

Till the 1930s the country had a user fee system, it was not 100% free. The free health care system was brought into the system in 1931 during the British era.

At the time there was a huge call for freedom from British rule. As a result the British Government appointed a committee that became known as the Donoughmore Commission. This commission declared Sri Lanka as a welfare state. Budgetary allocations were made to provide free health services.

In 1953 years after Independence, the Health Department was set up. There was a committee appointed in 1970, headed by Prof. Senaka Bibile and Dr. S.A. Wickremasinghe to look into ways to provide quality drugs to the people at lower prices. At the time we did not have a state mechanism for procurement. The Bibile-Wickremasighe report marked the inception of a Drug Policy in Sri Lanka.

As a result the State Pharmaceuticals Corporation was set up under the Industrial Ministry, the Minister was T.B. Subasinghe.

The first Chairman of SPC was Prof. Prof. Bibile, he did honorary service while working as the Dean at the Peradeniya Medical Faculty. The mandate of the SPC was to purchase drugs internationally, supply to the public hospital system and the masses via a network of 'Osu Salas'.

We received a Japanese grant in the 1980s to start manufacturingpharmaceuticals. Prof. Bibile developed the concept of essential drugs to ensure all essential drugs are made available in State institutions. Sri Lanka is a pioneer in introducing this concept to the world.

Subsequently the Government set up a drugs regulatory authority. There was wide consensus that we needed to regulate drugs circulated within the country. The registration of drugs was made mandatory under this Act. There is a procedure set up and the Director General of Health Services is considered as the Drug Authority. To support him another directorate was set up - the Medical Technology and Supplies Division. We were one of the pioneers in the region to set up such a mechanism.

Q: How does it work now?

A: The Health Ministry considers the SPC as its purchasing arm. We call international tenders. We have a system to purchase drugs from registered parties.

Any new supplier has to register with the Drug Regulatory Authority. For the registration they have to make an application and a panel of experts goes through the pharmacology aspects of the new drug. The manufacturing of the drug has to be through a WHO certified process.

We purchase drugs from such registered companies. That is the procedure followed at the moment.

Q: Why is it that we see a lot of unwanted drugs circulating in the market, when it has been established that we need just 270 odd drugs to treat diseases prevalent in the country?

A: The essential drugs list developed by Prof. Bibile has been later revised. Science is always advancing. New drugs are coming in, new technology is invented. All over the world new drugs and vaccinations are being introduced. It's a separate business, the pharmaceutical industry is a profit oriented industry.

But their products are used to save lives. We have to strike a balance between production and our affordability as a developing country. We have to assess the new technology introduced. People are aware of the developments on the global front via the media and the Internet.

They demand the latest technology. This is an issue we have confronted today.

There is a huge issue between demand and supply. This is the issue in Sri Lanka as well as the rest of the world. Essential drugs are there to treat major diseases. But different drugs are being developed everyday.

The Ministry of Health's vision is to have a healthy nation. New diseases crop up and new treatments are introduced.

We have a responsibility to make available the latest treatments. While doing that though, we need to look at the cost aspect, affordability and equity. There cannot be discrimination geographically or ethnically.

Q: But there is an allegation that Sri Lanka too is under the tight grip of a mafia controlled by multinational drug lords?

A: We have a Formulary, an estimate of number of drugs being used in the government sector. These estimates are prepared by the hospitals. This is sent to the Medical Supplies Division, they order the medical supplies and then they get distributed among institutions.

Once the drugs are imported we do a post marketing surveillance. There can be quality failures, even Australia and US have suffered. We need to minimise that and the post marketing surveillance is to minimise that.We also have quality control laboratories to test drugs. But we need to further strengthen these three sectors.

Q: At the moment we don't have a regulatory body to monitor private medical care institutions?

A: We do monitor them. The Private Health Sector Regulatory Council has been established under an Act. The Chairman is the Director General ofHealth Services. It is a body which regulates the private sector.Provincial Health Directors and nominees from the private sector are members of the council.

The scope is there. But there are issues in regulating privatemedical institutions.The provision of healthcare is the responsibility of the Government. The Ministry of Health is the responsible agency to ensure that. But the mandate of the Ministry is not confined to the provision of healthcare services through government healthcare institutions, it has a mandate to regulate the private sector as well. This regulatory council was established to do that.

We have to ensure quality, waste disposal, the qualifications, training, etc. All that has to be looked after by the state, we have a huge role to play.

Some issues have been identified and we are planning to amend thePrivate Health Sector Regulatory Act to give wider powers to theministry for better regulation. That is very important. Step bystep we are trying to streamline the areas that have issues.

Q: There seems to be no ceiling on medical bills of private hospitals.They charge patients outrageously, anything in the offing to lookafter this area?

A: Good that you raised this question. The Ministry of health has set up a network of healthcare institutions all over the country. We have 1047 healthcare institutions, a set of teaching hospitals all over, including in Jaffna and Batticaloa.

We have provincial and district general hospitals and base hospitals. From base hospitals upward we have consultant specialists. Sri Lanka has some of the best consultants in the world. The best trained human resource is in the state sector.

Anyone can get a very good service at these hospitals. We haveexpanded our OPD hours from 4.00pm to 8.00pm in all major hospitals.This was done to give more opportunities to less affluent people. From cough and cold to bypass and neurosurgery, facilities are there in the state sector.

We have opened this system to the people. When there is a system like this why would people want to go to private institutions?There may be more logistics facilities but the state sector has the best human resources, equipment and theatre facilities. Logistics like an A/C room, a television set are not vital to treat a patient.

We develop the private sector to minimise the outflow of foreignexchange, because some people go abroad to get treatment.

Q: The proposed drugs policy, is it indigenous or are wefollowing any (foreign) model?

A: It is still in the draft stage, therefore I cannot comment much. What we want to ensure in the policy is that quality and safe drugs are supplied at affordable prices to the people of the country. That is the basic policy framework. This is the aim of having a policy framework, to ensure that even the private sector offers high quality safe drugs at affordable prices.

We already have a mechanism but the new policy will strengthen that. Then we need to ensure the supply of drugs uninterruptedly to the people, to strengthen distribution and information as well as the regulatory system.

The laws that are in place at the moment are very strong, but we need to strengthen the administration part. Checks and balances and taking legal action part of it will be looked after, but one must understand that we cannot have a cure for all ills. It is an evolving process.

Q: How was this policy was drafted?

A: Following extensive stake holder consultations. A lot of experts - specialist doctors, pharmacologists - were consulted. A committee was appointed to draft it. It is currently with the Legal Draftsman's office following which it will be put before the Cabinet and then tabled in the Parliament after a Consultative Committee review.