Pushing for Drug Transparency



Access to medicines has long been considered a developing country issue of vaccines and basic 
medicines. But the rise in chronic diseases and expensive life-saving treatments is bringing the 
access debate to rich countries worried about the burden on healthcare budgets.  

This has become more important as Countries face the huge challenge of rare diseases and expensive treatments for diseases like cancer.

For example, in Switzerland, the cost of medicine per person has increased by 13% in just three yearsto CHF814 in 2017. The costs are largely driven by oncology and expensive combination therapies,
explained the Federal Office of Public Health (FOPH) at a press conference earlier this month in May2019

The FOPH estimates that nearly half of the 90 or so requests for approval last year were for 
treatments exceeding CHF100,000 ($99,097) per person per year.

Ahead of the World Health Assembly in Geneva,  towards end May 2019, an Italian draft resolution to end secrecy around drug pricing has already ruffled feathers 
among some governments and industry players.

The resolution proposed by Italy’s Minister of Health Giulia Grillo in February, 2019 urges the World Health Organization (WHO) and governments to boost transparency in four areas: drug prices, R&D costs, clinical trial data, and patent information.

Supporters of the resolution argue that transparency is essential to determine a fair price for 
medicines and ultimately make them more affordable. A recent OECD report on the industry 
reinforced this, stating that, “R&D costs and pricing structures are often opaque, raising legitimate 
questions about the value offered by some increasingly costly new treatments.”

While transparency has been discussed in global health circles for years, Swiss Global Health 
Ambassador Nora Kronig said that 
seeing transparency as a way to improve access 
to medicines is a new development.

WHO's definition of a fair drug price:

A ‘fair’ price is one that is affordable for health systems and patients and that at the same time 
provides sufficient market incentive for industry to invest in innovation and the production of 
medicines.
  

Is there such a thing as a fair price?

What is a fair price for drugs has become the question shadowing the discussions on transparency. 

Companies have typically defended high prices by pointing to much needed investments in research 
and development. But more research from the WHO, Switzerland and elsewhere shows that prices aredisconnected from costs and that drug company profits continue to rise.

Companies like Novartis and Roche have even said that costs are not the best way to determine prices

With new gene therapy treatments that cure diseases with a single treatment, they are calling for a 
shift to a value-based model based on patient outcomes and savings to hospitals and health systems rather than cost base.

Basically value-based pricing is a strategy of the pharmaceutical industry to avoid unveiling their real investment cost as alleged by some quarters.  

/23-05-2019

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Malaysia: Universal Health Care Coverage



Malaysia plans to overcome the challenges of achieving universal health coverage (UHC), says the Minister of Health, Datuk Seri Dr Dzulkefly Ahmad.

This will be through the implementation of the Enhanced Primary Health Care programme which addresses the increasing non-communicable diseases (NCDs) and mental health cases.

He also said the government was committed to achieving UHC especially for the vulnerable and underserved people within the population and this would be done through the Peka B40 programme for the low income group.

Malaysia shall continue to do whatever it takes to deliver high quality healthcare to all its people, and to reach each one of them.

"UHC is about equity and access to healthcare services for all, without incurring catastrophic financial hardship," he said at the 72nd World Health Assembly in Geneva on Tuesday, May 21, 2019

Dr Dzulkefly said that the 2017 Global Monitoring Report on Tracking Universal Health Coverage showed that Malaysia scored 70% in the UHC service coverage index.

However, its out of pocket (OOP) expenditure stood at 38% in 2018 although the WHO recommends that the OOP expenditure should be at around 20%

He said the government will also strengthen public-private partnership through the Health Advisory Council, which comprises eminent individuals including, but not limited to, the private medical fraternity.

"We will also address the sustainability of the existing health financing system, which is predominantly tax-based," he said.

Dr Dzulkefly said Malaysia will also enhance data quality and carry out data analytics on the available health indicators by utilising its centralised data storage system, MyHealth Data Warehouse (MyHDW).

Among the challenges that Malaysia faced in order to sustain UHC were the increasing disease burden involving communicable diseases (CDs) and NCDs, emerging ageing population and increasing workload in public facilities, said Dr Dzulkefly.

This is made more difficult with scarcity of financial and human resource which hamper efficient delivery, he added.

"Malaysia also faces continuous maintenance of health facilities, equipment and ICT infrastructure and the lack of capacity to monitor and evaluate the implementation of UHC," he said.

However, Dr Dzulkefly said that “leaving no one behind” has been the core of the government's policy-making.

The Sustainable Development Goals have been prioritized across the ministries in Malaysia and they are seriously looking at ways to help the people further.

/theSTAR 21-05-2019

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Wolbachia-infected mosquitoes as a new tool to contain Dengue



The government wants to stop fogging in selected areas in order to enable aedes mosquitoes to breed freely. 


Instead, mosquitoes infected with the Wolbachia virus will be released in 10 localities in the Klang Valley from July. The Wolbachia has the capability to prevent the dengue virus from replicating itself in the mosquito.
Deputy Prime Minister Datuk Seri Dr Wan Azizah Wan Ismail said the plan is to have these infected mosquitoes spread the virus around as a way to stem the spread of dengue fever.
“We want to prevent fogging so we don’t kill these mosquitoes,” she told the press at the Parliament lobby today.
A trial run in 2017, when four million infected mosquitoes were released in five localities in Shah Alam and Keramat, resulted in a 60% to 70% reduction in the incidence of dengue fever.
This time, the mosquitoes will be released in eight areas in Selangor and two in Kuala Lumpur.
It costs 50 sen to infect one mosquito with the Wolbachia virus, down from RM1 previously. The technology was imported from Australia.
Wan Azizah said the effort was necessary in view of the high incidence of dengue cases and deaths nationwide. In just the first three months of this year, the number of cases has risen by 146.3% and the number of deaths is up 84.4%, compared with the same period last year.
She also revealed that the use of artificial intelligence to predict where there will be a spike in the incidence of aedes mosquitoes and dengue cases is being considered.

/theSUN 02-04-2019

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Rare Diseases - Awareness and Funding Needed



In Malaysia, there is no official registry for rare diseases resulting in the absence of data as there is no tracking of the patients.

According to Rare Disease Malaysia website there are at least 79 types of rare diseases found in Malaysia.

Although the number of patients of each disease is small, rare disease patients as a collective is common.

The Health Ministry has yet to set an official definition for rare disease, complicating the monitoring and regulation of the management of rare diseases.

The Malaysian Rare Disorders Society (MRDS) has, therefore, taken it upon themselves to classify rare disease as a disease that affects less than one in every 4,000 people of the general population.

Malaysia does not have a National Rare Disease Policy.

Last year, a letter jointly written by three doctors from Universiti Sains Malaysia and University Malaya Medical Centre revealed that only 60% of rare disease patients in Malaysia are receiving treatment due to a lack of treatment options or a long waiting list.

On Dec 17 last year, Deputy Health Minister Dr Lee Boon Chye had told the Dewan Negara that the ministry would be formulating a National Framework for Rare Diseases but did not provide a timeline.

Dr Lee said the framework would include the setting up of a governance committee and a rare disease data system to facilitate policymaking, programmes, strategy and intervention.

Treatment costs for rare diseases are exorbitant, said Sunway Medical Centre Clinical Genetics external consultant Prof Thong Meow Keong.

“Drugs to treat neurological conditions such as spinal muscular atrophy may cost up to RM2mil yearly. Bone marrow transplants can come up to RM400,000, while growth hormones, up to thousands a month,” said Prof Thong.

The medical fees for rare disease sufferers are often well beyond the patients’ and their caregivers’ means, giving rise to the need for funding.

Malaysia Lysosomal Diseases Association (MLDA) president Lee Yee Seng said most parents have no choice but to rely on government aid and public generosity.

Lee himself has two daughters, Wei Ling and Yen Ling, diagnosed with Pompe disease, caused by an accumulation of glycogen in the lysosome due to a deficiency of acid alpha-glucosidase, an enzyme that converts glycogen to glucose. ERT for both of them can come to RM2mil annually.
 
Lee feels very grateful for the RM16mil budget allocated by MOH this year to Hospital Kuala Lumpur (HKL) for patients with rare diseases, including those suffering from LSD. Together with Zakat Selangor and corporate sponsorships, 50 LSD patients have benefited from these funds.

On Lee’s wish list are two key items: that the government come up with laws so that those with rare diseases can get prompt medical attention, and for stakeholders to come forward with funding to ease the suffering of those afflicted.

There are 90 other LSD patients registered with MLDA. The association was founded in 2011 and since then, 10 patients have died caused by complications brought on by their disease. For now, there is an urgent need for seven LSD patients to receive ERT treatments.

/theSTAR 28-02-201 


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Compulsory Vaccinations Proposed



Doctors have called for all children in Malaysia to be first immunised against diphtheria and measles as a practical way to kickstart the compulsory policy on vaccination as suggested by the Health Ministry. This is because both the diseases are the most serious.

Asia Pacific Pediatric Association secretary-general Datuk Dr Zulkifli Ismail said there was no need for a blanket ruling mandating vaccination for all 12 major childhood diseases.

“This would protect all children in schools, kindergartens and nurseries,” said Dr Zulkifli, who is also the technical committee chairman of Immunise4Life, an expert-driven community education initiative to promote immunisation.


Dr Zulkifli said at present, it is not mandatory for children to be immunised before being allowed to enrol in school.

He was responding to a statement by Health Minister Datuk Seri Dr Dzulkefly Ahmad on Saturday that it would be tabling a proposal and a policy to make immunisation vaccination compulsory.

According to the Health Ministry, misinformation about vaccination had led to a huge jump in the number of vaccine-preventable diseases, with cases of measles jumping over ten-fold from 125 in 2013 to 1,467 last year.

A lack of immunisation was detected last year in all six measles deaths recorded and in 19 of the 22 deaths from whooping cough (pertussis).

Countries that had made immunisation for certain diseases mandatory include France, Bel­gium and Italy.

Minister in the Prime Minister’s Department Datuk Seri Dr Mujahid Yusof said the Federal Territory Mufti had issued a fatwa stating that vaccines made in Malaysia were halal (permissible).
Mujahid urged sceptics debating whether immunisation vaccination was allowed in Islam to stop, adding that this was affecting children’s health. “In Islam, we are clear that based on the fatwa, it is encouraged for Muslims to vaccinate their children but it can be compulsory if this (non-vaccination) affects the health of the children,” he said.
/theSTAR 25-20-2019

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Effort made to reduce Drug Procurement Cost by the MoH



Patients of serious illnesses such as cancer may soon be able to get their much-needed drugs at lower prices. Deputy Health Minister Dr Lee Boon Chye said today this would be made possible through the introduction of a central pool procurement system that covered government hospitals, university hospitals and army hospitals. 

Through the system that will be introduced in October, several hospitals will be combined as a single buyer. This could help to reduce the cost of these medicines through bulk purchases. 

Under the new system, the Health Ministry will make purchases of at least 80 varieties of drugs together with the Education Ministry, which oversees university hospitals, and the Defence Ministry, which is in charge of army hospitals.    

Lee said discussions with the other ministries are ongoing. “We will also have to get the approval of the Finance Ministry,“ he told a press conference after attending a forum on “Improving Access to Affordable Cancer Treatments in Malaysia” at Universiti Malaya. 

Currently, cancer treatment in Malaysia can cost anything from RM16,000 to RM400,000. The high cost of medical care has become a major challenge for the public healthcare system as well as patients.

According to Universiti Malaya, more than 75% of cancer patients in Southeast Asia sink into financial ruin or die within a year of being diagnosed with the disease. 

In Malaysia, medical expense is a major contributor towards financial calamity. A total of 17% of those who seek treatment at government hospitals end up in financial trouble. Of those who seek treatment at university hospitals and private hospitals, 31% and 91% respectively experience financial catastrophe. 

According to the university, government health programmes such as Peka 40 and MySalam could help ease the burden of those in the B40 group. However, those who seek treatment at university and private hospitals are exposed to a high risk of financial crisis. 

Meanwhile, Pharmaceutical Service Division, Senior Director Dr Ramli Zainal said efforts would be made to obtain drugs at lower prices once current tenders have expired. “We also need to monitor and evaluate the progress of the central procurement system.

/theSUN 25-02-2019

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Malaysia: Health Tourism, Low Cost with Great Health Care



The article herewith is reproduced from "International Living Magazine-February 2019".

For years, many people from surrounding countries, like Indonesia, Hong Kong, and Singapore, have come to Malaysia for affordable, high quality healthcare. All the doctors speak English and most were trained in the UK, U.S., or Australia so they are familiar with Western standards of care. Also, many of the hospitals in Kuala Lumpur and Penang are JCI accredited, meaning that they are considered to meet the gold standard in healthcare throughout the globe.

More than 800,000 foreigners seek treatment in the hospitals in Penang and Kuala Lumpur every year. There are specialists in every hospital, but unlike in the U.S., you don’t have to wait for months to get an appointment. Just turn up to the hospital, register, then take a number and wait your turn. If you are then referred to another doctor, or need to get an X-ray or scan, that will also happen on the same day in the same place.

Prescriptions in Malaysia cost a third of what you pay at home. But it’s not just the cost that’s attractive; it’s the service. The pharmacists, like the rest of Malaysia’s medical staff, are well trained and informed. Malaysians are friendly people, but it’s the genuine interest that they take in you, no matter how small or large the issue, which impresses. It takes you back to a time when personal service meant something. That same service is alive and well here.

There are doctor’s clinics throughout the country, which are perfect places to get treatment for something minor like a cold, flu, or sinus infection. They usually charge $10 and because these are small clinics you won’t have to wait as long as you would in a busy hospital. But for anything more serious, it’s best to go to a specialist or general practitioner in one of the many top-notch hospitals in the country. A first-time doctor or specialist visit is usually between $15 to $65 with follow-up visits around $11 to $28. If you are admitted, the overnight stay will cost roughly $55 to $200 for a private room per night.

Many of the hospitals offer health screening packages which include a physical, chest X-ray, ECG, blood work (43 different tests), abdomen ultrasound, and a vision test. More specific tests can be added on but the basic package starts at less than $120.

Dentistry in Penang is just as high quality. Just like the doctors, most are schooled in the West and speak English. The technology is the same, and in some cases more advanced than at home, depending on the office you go to. Cleanings start at $22 at a modern office with state of the art equipment, and it’s only $29 for a filling. Porcelain crowns start at $400, all just a fraction of the cost in the U.S.

There is a two-tier healthcare system in Malaysia; government-run universal healthcare and a co-existing private healthcare system. Expats can choose whatever hospital they want and pay out of pocket if they don’t have insurance. Most expats choose to go to the private hospitals (which tend to be more expensive) instead of the public ones and will still save money when they pay out of pocket for most minor visits. Private health insurance is available, and many expats take out policies for any major health issues. International insurance companies like AIG, BUPA, and Cigna offer various plans for expats—some include medical coverage while you travel as well.
/International Living Mag Feb 2019

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Malaysia Population end 2018: 32.2 million



Malaysia’s population grew by 1.1 per cent to 32.6 million in the fourth quarter (Q4) of 2018, compared to 32.2 million in Q4 2017, demographic data released by the Department of Statistics Malaysia revealed.
Of the total, 16.8 million were male and 15.8 million female, chief statistician Datuk Sri Dr Mohd Uzir Mahidin said in a statement.
The preponderance of males was also reflected in births in Q4 2018 – 65,800 babies were male and 61,600 were female. In total, there were 127,400 live births during the period – a decrease of 2.5 per cent compared to Q4 2017, which saw 130,600 live births.
“Overall, Selangor is the most populous state in the country, with 6.5 million people; while the Federal Territory of Putrajaya has the lowest population, with 91,900 people,” Mohd Uzir added.
As for deaths, 41,400 fatalities were recorded in Q4 2018 – a decrease of 1.9 per cent compared to Q4 2017, which saw 42,200 deaths.
The number of males who died was 23,800, while females accounted for 17,600 deaths.
/NST 12-02-2019

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The deadly Disease: Cancer



Data shows that cancer strikes one in every nine Malaysian women and every 10 men.

To make matters worse, cancer is also mostly detected late in Malaysia with almost 60% of patients discovering it in stages three or four when the disease has already spread.


While the Health Ministry has been taking measures to battle the deadly disease, there is a lack of oncologists in the country.

There are only 115 oncologists in the country – just five more than the number in 2017. Of these, 42 are in government hospitals which include university hospitals, while the remaining 73 work in the private sector.

Health Ministry deputy Director General (public health) Datuk Dr Chong Chee Kheong said the ideal ratio would be eight to 10 oncologists per million people.

“If the Malaysian population is 34 million, the current ratio stands at 3.4 oncologists per one million people,” Dr Chong said.

He said 56 candidates were pursuing Masters in Clinical Oncology in Universiti Malaya, adding that the yearly intake would increase.

The existing National Strategic Plan for Cancer Control Programme (NSPCCP), he added, was also progressing well with improvements in screening coverage for main cancers such as colorectal cancer.

“Work is also in progress to build a cancer centre in the northern region,” he revealed.

On the late detection of cancer, he attributed this to mainly poor screen­­­ing uptake and delay in re­­cog­nising early signs of the disease.

“Detecting cancer at a late stage leads to higher cost of treatment and reduces the chance of a cure,” he said.

Dr Chong said 45% of cancer pa­­tients in Malaysia also faced financial problems, based on the Asean Costs in Oncology study by the George Institute for Global Health in Australia.

“This means the cost of their treatment exceeds 30% of family income after a year of being diagnosed with cancer,” he said.

He advised the people to change unhealthy habits, with the World Health Organisation estimating that between 30% and 50% of cancers could be prevented through a behavioural shift. Smoking, physical inactivity, unhealthy diets and alcohol intake were the risk factors for cancer.

/theSTAR 0-02-2019 

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Vaccinations: Misconception



Misinformation about vaccines has led to a huge increase in vaccine-preventable diseases, with almost a 1,000% increase in the number of measles cases compared to five years ago.
The number of measles cases increased from 195 cases in 2013 to 1,934 cases in 2018
From the figures, cases of measles without immunisation increased to 1,467 cases (75.9%) last year from 125 cases (68.7%) in 2013
In 2018, there were recorded six measles deaths where all were not immunised, and five cases of diphtheria deaths where four did not receive immunisation.
There were 22 deaths from whooping cough (pertussis) where 19 cases had no vaccination.
Health Director General, Datuk Dr Noor Hisham Abdullah said it was discovered through social media that certain individuals who objected to vaccines had influenced other parents to join them.
“The irresponsible action posed a challenge to the ministry’s efforts, and as a result, infectious diseases that could be prevented with vaccines had increased,” he said.
The World Health Organization has identified vaccine rejection as one of the global health threats for 2019.
“The misinformation on vaccination was spread by those obsessed with the claim that vaccination and the National Immunisation Programme carried out by the government were of no benefit and resulted in negative effects. The claim is not accurate,” he said.
The number of rejections to vaccines in government clinics increased to 1,603 cases in 2016 from 637 cases in 2013.
However, the numbers dropped a little in 2017 – to 1,404 cases – following the Ministry’s widespread advocacy efforts done in collaboration with the private sector and medical social media volunteers, said Dr Noor Hisham.
“If people continue to reject vaccines, there is a likelihood that infectious diseases that could be prevented by vaccines will continue to increase, and all efforts will be futile,” he said.
Dr Noor Hisham said immunisation has been given free to Malaysian babies and children in government clinics since the 1950s.
Currently, the National Immunisation Programme is able to prevent 12 types of infectious diseases caused by certain bacteria and virus.
With the immunisation programme and improvement in health services, Malaysia successfully reduced the number of infant deaths by 85% from 1970 to 2017, from 55.9 deaths for every 1,000 live births to only 8.4 deaths for every 1,000 live births.
Immunisation has also eradicated smallpox worldwide while polio had been eradicated in Malaysia, he added.
/theSTAR 23-01-2019
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Traditional and Complementary Medicine (TCM): Development in Malaysia



The World Health Organisation acknowledges that there is significant and increasing demand for Traditional and Complementary Medicine (TCM) practices and practitioners worldwide.


The Ministry of Health Malaysia hasalways been aware of the importance of TCM in Malaysia from the health care, economic and socio-cultural perspectives. The Ministry advocates TCM as a complement to modern medicine and strives to not only make safe and quality TCM services accessibleto the public, but by integrating them into the national health care system with the aim of achieving holistic health care for all Malaysians.

Registration of TCM pharmaceutical products by the National Pharmaceutical Regulatory Agency commenced in 1992, and in 2004, the Traditional and Complementary Medicine (TCM) Division of the Ministry was set up to look into the regulation of TCM practices and practitioners.

The Traditional and Complementary Medicine (TCM) Act 2016 (Act 775) which governs TCM practice and practitioners in Malaysia, was gazetted on 10 March 2016 and enforced on 1 August 2016. Malaysia is one of the very few countries to regulate diverse practices and practitioners of TCM. The enforcement of the Act will be conducted in phases.

 The Ministry has embarked on Phase 1 of the Act enforcement whereby the TCM Council has been formed and is currently making the necessary preparations for the enforcement of Phase 2 which will include registration of TCM practitioners as well as disciplinary proceedings.

The final phase will entail full enforcement of the Act including the Sections pertaining to enforcement related activities. There are also at present seven recognised TCM practice areas and six designated practitioner bodies to represent these practice areas in the Council. The Ministry is keen for the practice of medicine and health related professions in this country to be evidence-based.

The Ministry takes note that there has been research conducted in the field of TCM, especially in the countries of origin of recognised practice areas such as Chinese medicine, Indian medicine and chiropractic.

The Ministry supports endeavours by local researchers from the public and private sectors to undertake further research into TCM practices and products. Section 3 of the Medicines (Advertisement & Sale) Act 1956 is very clear on the prohibition of advertisements relating to certain diseases, and the relevant Schedule lists 20 of those diseases. This also applies to those who practice TCM.

Section 29 of Act 775 stipulates that any title or abbreviation used by a registered TCM practitioner should not cause the public to believe that the practitioner is qualified to practice medicine or surgery or dentistry as provided for by the legislation governing those professions. The TCM Council shall specify a list of prohibited titles and abbreviations which will be published once the relevant Section of Act 775 is enforced. Punitive action can be taken on any practitioner who registers with the TCM Council and is found to have used any prohibited title or abbreviation. /theSTAR 11-01-2019

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