Strict examination criteria needed for drug patents


Patent problem: The Health Ministry is paying high prices for many crucial drugs while generic versions can be obtained at lower prices.

Patent problem: The Health Ministry is paying high prices for many crucial drugs while generic versions can be obtained at lower prices.

THE PHARMACEUTICAL company for an important HIV/AIDS drug that combines Lopinavir and Ritonavir did not file for patents on the two base compounds in Malaysia.

However, between 1999 and 2006, several secondary patents were filed on the compounds and granted by the Malaysian intellectual property office.

The patents for Lopinavir and Ritonavir base compounds expired worldwide between 2014 and 2017 respectively. But unfortunately, the last secondary patent is due to expire in Malaysia in 2027.

“All of these increase the patent life of the drug by about another 10 to 12 years even though the base compounds are no longer under a monopoly in Malaysia and anywhere in the world,” says Third World Network legal advisor S. Sangeeta, pointing out the irony of drug patent issues.

The Malaysian Competition Commission review of the pharmaceutical sector revealed that the Health Ministry is paying high prices for this HIV/AIDS drugs – the patented drug costs US$1,489 (RM6,112) per patient per year under a Health Ministry procurement contract, while a generic version from India can be obtained at US$268 (RM1,100).

That would be about 82% savings for the Government if it had been able to gain access to the generic drug, says Sangeeta.

“When granting drug patents to pharmaceutical companies, the Malaysian patent office has to ensure that the invention is new, involves an inventive step and is capable of industrial application.

“But if countries loosely define the criteria, they can expect many patents being registered that extend the monopoly period and this delays generic versions from entering the market,” she says, adding that prices drop significantly, up to 90%, when there is robust generic competition.

Among the strategies used by pharmaceutical companies to prevent the entry of generic competition is a practice commonly known as ‘patent evergreening’ where multiple secondary patents are claimed over a pharmaceutical compound, patents over different forms such as crystals, liquids, tablets or heat-stable forms, uses, combinations, formulations and even dosages, she says.

It is important, that the ministry responsible for intellectual property and the patent office apply rigorous patentability standards on pharmaceutical patent applications, with the aim of avoiding secondary patents and patent evergreening, she says.

Sangeeta says that over the years, data from the US Food and Drug Administration shows that the number of new chemical entities for medicines has dropped since 1994, but the number of patents registered have increased, the US being usually the first country for patent filing.

This growth in pharmaceutical patents is a problem in developed and developing countries.

She also says that an Inquiry by the European Commission in 2009 revealed that in relation to 219 drugs, out of the 40,000 patents applications granted and pending, 87% were secondary patents.

“That means a large proportion of the patents granted are trivial patents,” she says.

The same inquiry found an estimated loss of around three billion Euros due to delays in the entry of generic products caused by misuse of the patent system, she says.

In South Africa, a study found 92 secondary patents were granted for 24 cancer medicines, with 74 likely to block competition from generic versions, she says.

She says there are lessons to be learned from other countries.

India, for instance, has a patent law which generally does not recognise patenting of new forms or uses of a known substance while Argentina has set up strict guidelines for the examination and grant of pharmaceutical patents.

Sangeeta believes there is a need for more sensitisation of the effect of the Malaysian patent office’s work on prices of medicines and access to medicines in Malaysia.

“If the Government does not ensure application of strict criteria for the examination of pharmaceutical patent applications, the prices of many life-saving treatments are going to remain high, and consequently, inaccessible to many patients.

“The bar has to be much higher, because now, many frivolous patents are being granted,” she says.

In 2016, the Report of the United Nation Secretary General’s High Level Panel on Access to Medicines recommended that World Trade Organisation Members adopt and apply rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants to curtail the evergreening of patents, and to award patents only when genuine innovation has occurred.

Sangeeta believes another measure that Malaysia can take to ensure only real inventions are patented is to introduce administrative pre- and post- grant oppositions system to patents.

She says that is because the court system is too time consuming and expensive.

“The opposition system will help patent examiners to conduct more rigorous examination of patent applications and have better examination practices. We are proposing the instituting of this opposition systems and that it be an administrative procedure and not a court case,” says Sangeeta.

Before a patent is granted, anyone who has an interest to file an opposition, such as generic drug companies or patient groups, could file an opposition before the patent office, showing why the patent should not be granted, she says.

A similar administrative procedure would apply after the granting of the patent in the form of a post-grant opposition system, she adds.

“Internationally, this has been found to be an important tool to ensure that patents are not wrongly granted,” she says, noting that this had a huge impact on facilitating access to affordable medicines in many developing countries.

“This would be especially beneficial and life-saving for patients suffering from cancer, HIV/AIDs, Hepatitis C, and rare diseases who pay very high prices for treatments,” she says.

TAGS / KEYWORDS:Drugs , Patent


Ministry of Health halts programme providing new drugs for free

The Health Ministry’s Pharmaceutical Services Programme website announced last Monday the temporary suspension of the Patient Access Scheme that involved free provision of drugs 'until further notice'. — AFP pic
The Health Ministry’s Pharmaceutical Services Programme website announced last Monday the temporary suspension of the Patient Access Scheme that involved free provision of drugs ‘until further notice’. — AFP pic

KUALA LUMPUR, Aug 16 — The Ministry of Health has suspended a scheme by pharmaceutical companies that provides expensive new medications, which are unavailable in public hospitals here, for free.

The move will potentially affect thousands of patients suffering from cancer and rare diseases.

The Health Ministry’s Pharmaceutical Services Programme website announced last Monday the temporary suspension of the Patient Access Scheme (PASc) that involved free provision of drugs “until further notice”.

The Ministry of Health (MOH) also sent a letter to pharmaceutical companies yesterday to inform them that it has decided to put on hold all PASc applications involving free medications for the time being, after a meeting between the ministry’s Pharmaceutical Services Programme and Health director-general Datuk Dr Noor Hisham Abdullah on August 9.

“For YBhg Datuk/ Datin/ Sir/ Madam’s attention, this division has been requested to obtain views from the National Audit Department on the issue of civil servants’ integrity in the acceptance of free packs upon the procurement of drugs,” Dr Kamaruzaman Saleh, director of the Health Ministry’s Pharmacy Practice & Development Division, said in the letter dated yesterday sighted by Malay Mail.

An industry source explained that the MOH was treating the PASc — in which many pharmaceutical companies provide certain expensive innovative drugs to a limited number of patients for free after selling other medicines to the government — as if it was a “gift” that violated government ethics and integrity guidelines.

“Putting this programme in the same classification as if was some form of ‘imbuhan’ or unethical incentive such as a paid holiday in Bali is not only erroneous, it risks harming and denying the chance and possibility of patients to be treated with better and much needed treatment options,” the source said.

Malay Mail understands that incoming PASc applications were suspended while pending ones were denied. The fate of current PASc programmes is uncertain.

Prime Minister Tun Dr Mahathir Mohamad said last month that ministers would be prohibited from receiving expensive gifts like vehicles and they would only be allowed to accept food, flowers, or pewter plaques.

Malay Mail reported in 2016 Roche Malaysia as saying that since 2007, it has helped more than 4,000 cancer patients get access to medicines through its patient assistance programme, or PASc, that provides drugs for free.

The pharmaceutical company told Malay Mail then that most of its life-extending medications were provided through that programme, as many of these drugs are not available on the MOH Medicines Formulary that lists the drugs provided in MOH hospitals here.

A kidney cancer patient, who was taking a targeted therapy drug he received for free on Pfizer’s patient assistance programme that was not available in public hospitals here, told Malay Mail in 2016 he could live a normal life despite his Stage Four diagnosis in 2006.

According to the Health Ministry’s PASc proposal submission guideline, the scheme includes both existing drugs in the MOH Medicines Formulary and those outside it.

“Patient Access Scheme (PASc) is a scheme proposed by pharmaceutical companies and agreed upon by the Ministry of Health (MOH), Malaysia in order to improve access to medicines which are likely to have high budget impact either due to high treatment cost per patient and/or large volumes of use,” said the guideline.

“This scheme may address the rising cost pressure, consumer demands and uncertainties, while attempting to provide patient access to innovative care within finite budgets.”

When contacted for comment on the suspension of the PASc, Deputy Health Minister Dr Lee Boon Chye told Malay Mail: “We postponed PASc implementation at this point of time for us to have further discussion with Audit Negara”.

“Need to discuss internally to comply with audit standard,” he said.

Dr Noor Hisham did not respond to queries outside office hours.

Those at risk urged to get screened for Hepatitis C

  • Saturday, 28 Jul 2018

KUALA LUMPUR: Asnah Hamdan suspected something was wrong when she had bruises all over her body during a blood transfusion following the loss of her second child more than 35 years ago.

The 66-year-old former Malaysian Railways employee from Perak said during a routine medical check 10 years later, her doctor casually said: “Asnah, your blood has something.”

But he did not suggest any follow-up.

Asnah said she never had any symptoms. “I didn’t feel sick at all.”

While she was not afraid when informed, her husband of over 50 years had a hard time accepting her diagnosis because his late cousin only knew of her Hepatitis C status towards the end of her life.

But Asnah reassured her husband that the doctors would keep a watchful eye on her and that he need not worry.

“He wants to know why I’ve not been given any medication. It gives him great pain,” she said.

A person may be infected with Hepatitis C for 20 to 30 years before developing symptoms. Left untreated, it can cause liver cirrhosis or liver cancer. Today, there is a cure for Hepatitis C with only three months of treatment.

Dr Muhammad Radzi Abu Hassan, a consultant physician and gastroenterologist at Hospital Sultanah Bahiyah in Alor Setar, urged those at risk, especially people who injected drugs and shared needles and those who had blood transfusions before 1990, to get tested.

“You can get cured,” he assured.

The good news is, Asnah’s husband need not worry anymore – Asnah will begin treatment in August as free treatment in government hospitals has been made available since March.

World Health Organisation Representative to Malaysia, Brunei Darussalam and Singapore Dr Lo Ying-Ru called for increasing access to Hepatitis C testing and treatment. She urged people in high-risk groups to step forward to be tested as there is now a cure.

While congratulating the government for increasing the number of hospitals for treatment, Dr Lo said they should come up with a comprehensive national action plan on viral hepatitis which covered all aspects such as prevention, diagnosis and treatment.

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MTAAG+ group seeks better treatment for patients

Wait over for Hep C screening


Wait over for Hep C screening

The cure: FIND HCV country project manager Sem XiaoHui showing the rapid diagnostic test kit for Hepatitis C at the Drugs for Neglected Diseases initiative office in Brickfields, Kuala Lumpur.

The cure: FIND HCV country project manager Sem XiaoHui showing the rapid diagnostic test kit for Hepatitis C at the Drugs for Neglected Diseases initiative office in Brickfields, Kuala Lumpur.

KUALA LUMPUR: In another step up for Malaysia on access to Hepatitis C diagnosis and treatment, 50,000 rapid diagnostic test kits will be made available to high-risk patients in selected clinics.

Global health non-profit body Foundation for Innovative New Diagnostics (FIND) – in collaboration with Drugs for Neglected Diseases initiative – will help the Health Ministry to kick-start the screening process in a big way.

Access to Hepatitis C screening and treatment was limited due to high treatment costs coupled with the lack of awareness, symptoms and screening facilities.

Former health minister Datuk Seri Dr S. Subramaniam announced in March that around 2,000 patients would be treated in public hospitals after the Government gained access to a generic version of the medication sofosbuvir through compulsory licencing (CL).

FIND HCV country project manager Sem XiaoHui said it would provide technical assistance to the ministry and demonstrate the easy-to-use rapid diagnostic test (RDT).

The 50,000 RDT kits would be distributed to 25 selected health clinics within 12 months from mid-September, she said.

“It requires only a finger prick. The RDT is fast and can produce highly accurate results in five to 20 minutes,” she said.

Currently, confirmation tests are available only in state and referral hospitals and patients may need to wait up to a month for the results because these are only tested in laboratories and are labour-intensive, she said.

Sem said the ministry’s first edition HCV guidelines introduced on Oct 17 had put RDTs as a recommended diagnostic test.

The RDT selected was based on the World Health Organisation’s (WHO) recommendation, she said.

On July 23, Drugs for Neglected Diseases initiative (DNDi) said in a statement that it would partner with FIND to generate evidence that would support policy change and the scale up of HCV diagnosis and treatment.

The work will be carried out with the ministry.

It is part of a larger FIND project, known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), and is supported by Unitaid, a global health initiative working with partners to end the world’s epidemics.

It said patients confirmed having active HCV (viremia) would be treated as part of an ongoing DNDi clinical trial – co-sponsored by the ministry – using a new, alternative treatment regimen combining sofosbuvir with the investigational drug ravidasvir.

Patients could also be treated at selected government hospitals through the national HCV programme using generic versions of sofosbuvir/daclatasvir.

Sem said the efforts – decentralising testing and services and making these accessible at the clinic level – were aimed at achieving WHO’s viral hepatitis elimination goals, which was to get 90% of the population screened and diagnosed and 80% treated by 2030.

Sem said less than 20% of the general global population were aware of their Hepatitis C status.

DNDi South-East Asia clinical project manager S. Sasikala said of the 50,000 people screened, 1,200 were expected to require treatment and be absorbed by DNDI and the ministry’s clinical trials in five district/state hospitals.

She said high-risk populations such as those injecting drugs, care providers, those in homosexual relationships, HIV patients, sex workers, those had received blood transfusion before 1992 and family members of infected patients should get tested for HCV.

“The Institute for Medical Research has evaluated the kit and it has very good sensitivity and specificity,” said Health director-general Datuk Dr Noor Hisham Abdullah.

Asked if Malaysia could eliminate Hepatitis C through its public health approach after the CL, he said it was on track on achieving this by 2030.

Although the ministry said it would provide a limited 2,000 treatments this year, Dr Noor Hisham said this capacity would be increased in stages.

Patients had to register with 21 hospitals which provide the treatment, he added.

Related stories:

MTAAG+ group seeks better treatment for patients

Those at risk urged to get screened for Hepatitis C


Health Ministry inks MoU to help diagnose Hepatitis C among vulnerable populations

Health Minister Dzulkefly Ahmad delivers his speech before the signing of the MoU between Clinical Research Malaysia and the Foundation for Innovative New Diagnostics in Putrajaya August 6, 2018. — Picture by Azinuddin Ghazali
Health Minister Dzulkefly Ahmad delivers his speech before the signing of the MoU between Clinical Research Malaysia and the Foundation for Innovative New Diagnostics in Putrajaya August 6, 2018. — Picture by Azinuddin Ghazali

KUALA LUMPUR, Aug 6 — The Ministry of Health (MOH), via Cancer Research Malaysia (CRM) today inked a Memorandum of Understanding (MoU) with the diagnostic firm to help identify and treat Hepatitis C patients in vulnerable, hard to reach populations.

Health Minister Dzulkefly Ahmad, who witnessed the ceremony, today said that the larger concern regarding the disease in Malaysia is the amount of undiagnosed cases.

As such, the Foundation for Innovative New Diagnostics (FIND) will demonstrate the conduct of Rapid Diagnostic Tests (RDTs) in several government health clinics, and link them to care.

“Treatment is now available in 21 government hospitals. The clinical trial (diagnostics) will be in 25 health clinics,” Dr Dzulkefly said following the signing.

One care option is to link the patients with Drugs for Neglected Diseases Initiative (DNDi), which conducts clinical trials co-sponsored by MOH.

There are around 500,000 Hepatitis C patients in Malaysia.