Malaysia

There is a global “war” being waged in the health industry.

Civil societies and several governments in poor as well as rich countries – including Malaysia – are up in arms over pharmaceutical companies setting prices so high that some life-saving drugs are beyond the reach of many.

The concern over astronomically expensive drugs and the lack of accessibility has reached the World Health Organisation (WHO) level, and access to medicines and vaccines is expected to be among the top items on the agenda at the 72nd annual World Health Assembly in Geneva, Switzerland, beginning on May 20 (the assembly ends on May 28).

Sofosbuvir (400mg) was priced at US$8,939 (RM37,767) for a standard 12-week treatment regimen upon launch in China in November 2017, but generic alternatives are available for US$249 (RM1,052), a potential 98 per cent price reduction enabled by this decision, it says.

Geneva-based Health Policy Watch says that the WHO’s executive board in January held a lengthy debate on a road map for access to medicines, and now it will be put before the assembly.

On Feb 1, Italy proposed that the WHO set international standards for drug-pricing transparency. It has asked the assembly to adopt a resolution that would require drug makers to disclose their R&D and production costs, as well as prices charged for medicines and vaccines.

The proposal sent to governments on April 29 had 10 co-sponsors and Malaysia is one of them; the rest are Italy, Greece, Portugal, Serbia, Slovenia, South Africa, Spain, Turkey, and Uganda.

Italy’s proposal “has generated significant discussion and may be overshadowing the focus on the WHO roadmap to access to medicines, vaccines and other health products,” says Health Policy Watch.

Skirmishes already began on May 7 at informal negotiations ahead of the assembly.
Several developed countries have proposed amendments to Italy’s proposal that activists claim will make it confusing, weak and useless in many areas. Some countries have also sought to postpone discussion of the proposal.

Following such resistance, more than 100 civil society organisations and health experts sent an open letter to WHO member state delegates on May 9, urging them to oppose harmful proposed changes to the resolution.

The proposal will give the WHO and national governments a strong mandate to collect and analyse data on drug prices, R&D costs, clinical trial results and costs, the patent landscape, and more, says the letter.

“At a moment when the public is looking to their elected governments to address the crisis in the pricing of new drugs and other biomedical inventions, the WHO has been asked to do something important: improve the transparency of markets for biomedical products and services,” says Knowledge Ecology International’s (KEI) director James Love on its website.

The International Federation of Pharmaceutical Manufacturers and Associations warns that the Italian proposal could lead to unintended consequences for the capacity of companies to offer preferential pricing to developing countries, and that it must be seen from diverse perspectives.

It urges WHO and its member states “to conduct careful analysis of the potential benefits and risks to patients and to health systems, particularly for less developed countries, in addition to future innovation,” the Health Policy Watch reports.

The federation says its industry has responded to concerns raised in the proposal, citing its Principles for Responsible Clinical Trial Data Sharing, and the Patent Information Initiative for Medicines as examples.

RADICAL MOVES THAT TUMBLED PRICES

In the last few years, some countries have resorted to drastic legal action to gain access to affordable drugs.

Malaysia came to the forefront of this issue when, in 2017, it became the first country in the world to impose a compulsory licence to gain access to the cheaper generic version of the hepatitis C drug sofosbuvir for about 400,000 of patients.

The hepatitis C virus affects about 71 million people globally, over 66 million of whom are not being treated, according to the WHO. This is despite the fact that 95 per cent of people with hepatitis C can be completely cured within two or three months of beginning treatment.

The compulsory licence is provided for under the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights. It allows for the generic version of a drug to be imported or manufactured while it is still under patent protection.

Malaysia was placed under a lot of pressure for the move, prompting the Health Ministry, on Feb 25, to urge the WHO to look into the pricing system of medicine by pharmaceutical companies.

The hepatitis C virus affects about 71 million people globally, over 66 million of whom are not being treated, according to the WHO. This is despite the fact that 95 per cent of people with hepatitis C can be completely cured within two or three months of beginning treatment.

Last August, China compelled a pharmaceutical company to withdraw unmerited key patent claims on the sofosbuvir base compound. With 10 million people in China living with chronic hepatitis C, the ruling opens the door to affordable generic treatment ahead of the patent’s expiry in 2024. The base compound patent on sofosbuvir was granted in China in 2009.

A nonprofit that specialises in uncovering unfair patents, Initiative for Medicines, Access & Knowledge (I-MAK), estimates that treating just 15 per cent of China’s hepatitis C patients with generic drugs would save US$13 billion (RM54.9 billion), with a massive US$87 billion (RM367.5 billion) saved if all patients are treated.

There is a growing global momentum to challenge unmerited patents to ensure more people can access life-saving treatments, I-MAK says.

Sofosbuvir (400mg) was priced at US$8,939 (RM37,767) for a standard 12-week treatment regimen upon launch in China in November 2017, but generic alternatives are available for US$249 (RM1,052), a potential 98 per cent price reduction enabled by this decision, it says.

China is also overhauling its healthcare system to provide better access to quality drugs and treatment for its population.

In December, news agency Bloomberg reported that the government had asked 11 major cities to band together to buy drugs in bulk through a tender process to bring down prices.

PATENT PROBLEMS

It’s not just developing or poor countries that are struggling with high drug prices.

In the United States, 18 lawmakers wrote to the US Department of Health and Human Services in February last year to consider issuing a compulsory licence for expensive hepatitis C treatments because rationing high cost treatment was harming the country’s public health.

“It is morally repugnant when ailing patients are forced to choose between filling that next prescription or putting food on the table, because they can’t afford both. It is morally repugnant when patients are forced to skip doses.”

On Feb 5 this year, President Donald Trump, in his State of the Union address, called on Congress to contain the rising costs of prescription medications, saying it is unacceptable that Americans pay vastly more than people in other countries.

I-MAK exposed drugmakers’ abuse of patent law in the United States in 12 bestselling drugs in 2017.

To protect themselves from competition, drug companies file hundreds of patent applications – the vast majority of which are granted – to extend their monopolies far beyond the standard 20 years of protection granted under US patent law.

I-MAK says the average number of years blocking generic competition are 38, years blocking patent applications are 125 and the average price hike since 2012 is more than 68 per cent.
The US Senate Finance Committee launched a bipartisan probe to examine drug pricing in the United States and the rising costs for consumers and taxpayers.

During the hearing on Feb 26, the committee censured a drug company that had, in 2017, spent around US$11.5 billion on dividends, stock buybacks, marketing, sales and administrative costs – roughly triple the amount it spent on R&D.

It also lambasted another company for increasing the price of insulin from less than US$100 in 2010 to nearly US$300 last year (the company raised prices again this year).

The committee also said that in 2017, a portion of a CEO’s multi- million-dollar bonus was directly tied to sales of an arthritis medication.

“Over six years, the company doubled the price of a 12-month supply from US$19,000 to US$38,000 .

“Can patients opt for a less expensive alternative? No they cannot,” it said, adding that the company protects the exclusivity of the drug like Gollum with his ring (referring to the character in the Lord of the Rings series).

“It is morally repugnant when ailing patients are forced to choose between filling that next prescription or putting food on the table, because they can’t afford both. It is morally repugnant when patients are forced to skip doses.”

Top executives from the seven largest drug companies were also hauled up before the committee to explain the skyrocketing cost of prescription drugs.

On May 15, the committee tweeted again, saying: “@HHSGov is starting to look into drug company middlemen that take millions from taxpayers. But more needs to be done to prevent these middlemen from using schemes like ‘spread pricing’ to take big profits while taxpayers get stuck with the check.”

(How spread pricing affects the consumer: a pharmacy benefit manager company pays a pharmacy a minor amount for a drug but charges the health insurer that employs it much higher prices; the insurer in turn will charge its customers higher premiums to cover its costs.)

THE COMPARISON METHOD

In Europe, issues relating to external reference pricing was reignited by an unprecedented meeting in Brussels in mid-April that brought together national pricing authorities with drug companies, patients, payers, physicians, and civil society.

A decade ago, EU national authorities conceived a scheme known as Euripid to boost their negotiating powers with pharmaceutical manufacturers by exchanging pricing information among themselves. (One country compares the price of a drug in several other countries to derive a reference price that is then used to negotiate the product’s price in that country.)

Pharmaceutical companies say this could hinder drug access since companies tend to delay the launch of products in countries with the lowest prices, to counteract the downward pressure in price-comparison baskets. The industry is also pushing back against Euripid’s ambitions to shift its focus from list prices to net prices, PharmExec.com reports.

Now, with more countries holding pharmaceutical companies to account, more intense debate is expected at the WHO assembly on May 20.

More transparent pricing and a redirection of how medicines are sold is urgently needed.
Buying most products and services is a choice – but you can’t choose not to buy medicine, so if you need that patented drug to save your life, you have to find some way to cough up the exorbitant price.

This does not work, especially on a global scale, where millions lack access to the treatment for certain infectious diseases that continue to spread, setting up a vicious cycle. This is a free market failure that must be addressed.

The fight for price transparency saw fruition in May, when the concern was discussed at the World Health Assembly in Geneva, Switzerland.

The drug price transparency resolution proposed by Italy for the WHO was adopted. Although diluted, civil society organisations and many countries were glad that it had made an inroad and the initial resolution serves as the first step in bringing greater disclosure of prices.

The resolution covers all health products, which include medicines, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies, and other health technologies.

This story by Loh Loon Fong was originally published on May 19.

Just imagine this: plastic milk bottles infested with maggots find their way to Malaysian shores after their contents are consumed by Australians. Also being dumped on our soil are plastic bread wrappers that originate from Canada, Japan and France.

That’s not all. Industrial electric cables disguised as copper from the United Kingdom and stacks of damaged electric and electronic cables are covertly heaped onto Malaysia.

Plastic cups used for drinking zam zam water in Mecca , Saudi Arabia, also end up in this country.
Hundreds of thousands of tonnes of plastic waste are dispatched to Malaysia every year, part of which is stuck in hundreds of containers that have remained unclaimed in several ports in Malaysia.

Recently, the Royal Malaysian Customs Department in Penang detected 265 containers of plastic waste that have not been claimed since January this year. At Westports in Port Klang, 152 containers believed to be filled with contaminated plastic waste have also been lying unclaimed.

Sources told Bernama that the relevant parties were reluctant to claim the containers for fear that the Ministry of Energy, Science, Technology, Environment and Climate Change (MESTECC) would take stern action against them in its effort to restrain other countries from treating Malaysia as a dumping ground for their waste.

There have been instances when a container carrying waste is registered as coming from China but in reality, its contents are from France.

Southeast Asian countries such as Malaysia, Thailand, the Philippines, Indonesia and Vietnam are known to serve as the world’s ‘garbage bins’ as they receive waste from several developed countries like the United States, Japan, Germany, Britain, Belgium and Canada.

The situation worsened after China imposed restrictions on the import of recyclable paper and plastic in January 2018. This resulted in more waste being diverted to Malaysia. Some 750,000 tonnes of plastic waste worth more than RM483 million (US$115.5 million) entered this country in 2018, according to the Institute of Scrap Recycling Industries. China’s import of waste dropped from more than 600,000 tonnes a month in 2016 to 30,000 tonnes a month since January 2018.

Thailand has also taken action to stop the import of plastic waste while Vietnam has introduced tight control pertaining to this matter as it does not want the country to be used as a garbage bin by developed nations.
Recently, Malaysia was among the 187 countries that were signatories to the amendments to the Basel Convention to make global trade in plastic waste more transparent and better regulated. The amendments will be enforced on Jan 1, 2021.

FOUL SMELLING, ROTTING

Why does Malaysia have to take on the burden of disposing of all that foreign garbage, most of which are shipped from developed countries?

Apparently, both the exporters and importers involved label their consignments as “waste for recycling”. The reality, however, is very different as the bulk of the imported waste materials is not fit for recycling.
According to sources, not all the waste materials that enter this country come in hygienic conditions; on the contrary, they reek of rotting garbage and are infested with worms.

One source said it was obvious that the recycling companies importing the waste were willing to turn a blind eye to the environmental pollution they were causing as a result of separating, cleaning, burning and disposing of the plastic waste that cannot be recycled.

“The ‘reward’ they get is only 60 sen for each kilogram of waste that is supposedly processed,” said the source.
The source added that even if the waste is recyclable, it has to be separated and cleaned thoroughly, which would require plenty of resources such as clean water.

“Waste that cannot be recycled will end up being burnt in the open. This can lead to carcinogenic toxic fumes being released into the environment, like what happened in Jenjarom (Selangor) recently.”

Malaysia’s soil and waterways also face threats from pollution during the cleaning process when water from the waste seeps into the ground. “In some cases, the waste is dumped on abandoned land or in the forest and left there,” said the source.

ILLEGAL FACTORIES

The situation worsens when recycling companies without their own waste processing premises hand over this task to factories that operate illegally all over the country, especially in areas located close to the ports.

“Selangor is among the states that have many illegal factories. Despite taking action such as closing down their premises and taking them in court, the owners (of the illegal factories) easily find new places to operate from,” said the source.

In its effort to curb environmental pollution, Mestecc has ordered 148 illegal plastic recycling plants to cease operations between January and April this year. These factories include 33 located in Jenjarom that had contravened the Environmental Quality Act 1974.

Since May , the ministry has inspected 123 containers carrying solid waste from the United Kingdom, United States, Japan, China, Spain, Canada, Australia, the Netherlands, Germany, Saudi Arabia, Singapore, Bangladesh, Norway and France. These containers gained entry into Malaysia via approved permits (AP) issued by the National Solid Waste Management Department.

Sixty of these containers, filled with 3,000 tonnes of plastic waste, will be shipped back to the country of origin after thorough inspections by the authorities.

Mestecc Minister Yeo Bee Yin said 10 out of the 60 containers would be dispatched to the country of origin within 14 days. The ministry had previously ordered five containers of waste to be shipped back to Spain where they originated, she said, adding that the action was taken under Malaysian laws, including the Environmental Quality Act.

DIFFICULT TO DETECT

One of the pressing challenges faced by the ministry in ‘repatriating’ the imported waste is detecting the country of origin.

There have been instances when a container carrying waste is registered as coming from China but in reality, its contents are from France.

According to sources, certain unscrupulous middlemen alter the Bill of Lading (BL) to confuse the authorities and make it difficult for them to ascertain the container’s country of origin. In the shipping industry, making alterations to the BL, such as the name of the exporter and country of origin, was a normal practice to ‘smoothen business transactions’. As the link between the exporter and importer of the waste, it is the middleman helps to tweak the information as desired by his clients so that the consignment lands in the importer’s country.

Many plastic waste exporters also evade the Harmonised Commodity Description and Coding System (HS) by exporting using the 3920 code for solid waste such as plastic plates, sheets, films and foil strips. HS is a global system of classifying products that are traded internationally. To hasten the export process, these exporters avoid using the 3915 code for plastic waste, which also covers pens and scraps, because they would then require an AP.

Based on the industry’s practices, it is clear that many people are willing to commit fraud to gain from the global plastic waste trade, which has an estimated annual market value of US$5 billion.

To prevent the further pollution of our country, both this industry and foreign countries need to clean up their act.

This story by Nur-ul Afida Kamaludin & Ali Imran Mohd Nordin was first published by Bernama on June 7.

They are sold a dream – of a ticket to study and work in a foreign country, but after spending their family’s entire savings, they are caught in the harsh reality of being trafficked and trapped in a constant cycle of exploitation and extortion.

Thousands of young Bangladeshis have been trafficked to Malaysia through obscure private colleges and their unscrupulous “agents”.

Some pay over RM 20,000 (US$4,781), equivalent to three years’ wages in Bangladesh, for the agents to secure student visas and admission into these bogus colleges.

But that’s just the beginning of the exploitation.

When they arrive in Malaysia, the victims realise the colleges don’t offer any real classes, they can’t work under student visas, and there are often additional “fees” to be paid.

Many have no choice but to work illegally under inhumane conditions, creating a cycle of exploitation where they have to earn enough to repay their debts and buy a ticket home, or pay the agents again to renew their student visas so they can work another year.

“I can’t go home, because my family spent all their money on the agent fees.

“Now I need to work here to pay for my father’s medicine,” said one victim, 24, whose father has suffered two strokes.

The team met up with agents while posing as factory managers looking for cheap labour, infiltrated the colleges, and followed the trail all the way to Dhaka, Bangladesh. One agent told our journalist he works for a “Datuk” who owns a college in Kuala Lumpur, and that he has trafficked over 8,000 Bangladeshi students to Malaysia.

“Bangladeshi students are easy and quick money,” said the agent, who is Nepali.

“Bring in 200 or 300 of them, then distribute them (among the colleges), then you’ll make your money.”

Many of these victims live and work not far from the glittering lights of the Klang Valley’s major towns, hidden and suffering.

“Our living conditions here are worse than the garbage dumps in the slums of Dhaka,” said one victim, now a construction worker living in a makeshift ghetto in Cyberjaya.

His family had to take a loan to pay for his “studies” in Malaysia, for which they pay 21,000 taka (US$248) a month in instalments.

He now earns around RM1,500 a month.

“In my college, there were around 200-250 Bangladeshi students, but only 30-35 have renewed their visas (to continue studying).

“Where the rest are, we don’t know,” he added.

During the course of its investigation, R.AGE met over 30 student trafficking victims, and found almost 30 colleges that showed signs of having worked with student traffickers.

When a R.AGE journalist posing as a prospective student went to one of these colleges, an employee quietly warned him against signing up.

“If our own people (Malaysians) come, I’ll tell them not to study here,” she said.

“Look around, the whole place is empty! I wouldn’t want any Malaysian students stuck here.”

“Our living conditions here are worse than the garbage dumps in the slums of Dhaka,” said one victim, now a construction worker living in a makeshift ghetto in Cyberjaya.

An earlier report by The Star revealed a large number of foreign students arriving through dubious colleges in 2013. The Ministry of Higher Education revoked the international student licence of four such institutions in 2015.

Since then, a further 26 institutions have had their licences revoked or not renewed.

Though many of these colleges can no longer enrol international students, they continue to operate by channelling students to other affiliated colleges.

“We do have something like a collaboration, a group of companies,” said the Nepali agent.

“We have a language centre and four colleges, all are like ‘joint-venture’ companies.”

He also claimed that he enrolled 3,000 Bangladeshi students at one of these colleges, but R.AGE found its campus to be nearly deserted.

“I came here to study. Only to study. But now, my dream is dashed,” said one victim.

First published on Aug 14, 2017, the series of reports on the exploitation of Bangladeshi college applicants, which includes a Peabody Award-nominated documentary series Student/Trafficked, led to a crackdown on the practice by the Malaysian government.

It’s about time someone spoke up about student trafficking, the Bangladeshi community said.

“All of us appreciate that R.AGE took this step to show what many Bangladeshi students go through,” said Bangladeshi Student Union Malaysia president Mohammad Ziaur Rahman Zia about the documentary series.

Mohd Hafizuddin, a bartender, said he wished the series had been launched before he came here. He paid RM15,000 to an agent to enrol for a diploma in Multimedia Applications, and only later realised the college was a sham.

“If I knew it would be like this, I wouldn’t have come,” he said.

Over two dozen colleges/institutions had their international recruitment licenses revoked, and the number of student trafficking victims from Bangladesh has since drastically reduced after R.AGE’s coverage.

“The Malaysian government has not been issuing visas to colleges for the past year,” said Abdur Rahim Khan, CEO of Bangladesh Malaysia Study Centre (BMSC). BMSC is one of the more established student recruitment agencies in Bangladesh, and specialises in sending students to Malaysian higher education institutions.

“This is good, because college students don’t go to Malaysia to study – only university students do,” he claimed.

Colleges and universities were also encouraged by the Higher Education Ministry to apply anti-trafficking guidelines proposed by R.AGE, of which five colleges and universities pledged to implement in December 2017.

However, despite the then-Home Minister himself pledging to bring those involved to justice, no syndicate leaders were arrested in connection with the investigations.

This story by Elroi Yee and Shanjeev Reddy is a compilation of articles from Aug 14, 2017 to March 12, 2018 that was originally published by The Star.