New laws will ensure better healthcare:
Quality and affordability, the hallmarks of new drugs policy
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
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
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
They demand the latest technology. This is an issue we have
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
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
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.