When so many lives are at stake

A RELATIVELY new medicine that can cure a life-threatening disease is now caught up in a global and local drama – how to make it available to the millions of patients who are literally dying to have access to it.

The disease is Hepatitis C, which affects over 450,000 Malaysians.

Worldwide, 150 million people have chronic Hepatitis C infection and 500,000 die yearly, according to the World Health Organisation.

It damages the liver, is a major cause of liver cirrhosis and can also lead to liver cancer.

The medicine is sofosbuvir, produced by Gilead and approved by US health authorities in December 2013.

Taken in combination with another drug, sofosbuvir has a cure rate of around 95%.

It is far superior to the conventional treatment of interferon in conjunction with ribavirin, which has many side-effects and an inferior efficacy rate.

Access to sofosbuvir would dramatically improve the cure chances of Hepatitis C patients, enhance their life quality and save lives.

The problem is the astronomical price normally charged by the original producer – for a 12-week course, it sells for US$84,000 (RM360,108) in the US and for £35,000 (RM231,461) in Britain.

At a workshop in Kuala Lumpur on Aug 25, the issue of Hepatitis C medicines was discussed by policy makers, health and consumer groups and organisations representing patients, with international experts from Medicin Sans Frontier (Doctors without Borders), Drugs for Neglected Diseases Initiative and the South Centre providing input.

In Malaysia, sofosbuvir is in the process of registration with the Health Ministry.

Doctors can, in the meantime, apply for their patients to get the medicine on a case-by-case basis.

The workshop heard that a patient in a Malaysian private hospital, which obtained permission to use the drug, was charged RM385,000 for a 24-week course.

The bad news is that very few Malaysians can afford such a high cost.

The good news is they need not do so if they are willing to use other methods to obtain the medicine.

Or if the Government is willing to take measures to make it available at a much cheaper cost.

A generic version of sofosbuvir (taken in combination with ribavirin) is available in India for about US$913 (RM3,914) for a six-month course. Even the branded product of the original company is selling in India at about US$1,800 (RM7,716.60) for a six-month course.

This was revealed at the workshop by Leena Menghaney, the Delhi-based South Asia director of Medicin Sans Frontier’s Access Campaign.

It is still not cheap but the generic price is about only 1% of the RM385,000 charged to the patient in Malaysia.

It is worthwhile for a Malaysian patient to spend three or six months in India to receive the treatment.

Alternatively, Malaysian regulations allow a patient or a family member to bring back a month’s supply of medicines from abroad or to receive medicines for personal use in postal packages.

Why is the medicine relatively cheap in India?

The main reason is that India has rejected granting a patent on sofosbuvir because the drug was not sufficiently novel and inventive as required by a patent.

Hence, Indian generic companies are able to produce their own versions of the drug.

Facing competition from generics, Gilead has also offered a price lower than what it charges in the US, or what it charged the patient in Malaysia.

Gilead also entered agreements with seven Indian companies allowing them to produce sofosbuvir but on condition they can sell to only about 100 developing countries.

Unfortunately, Malaysia is excluded from this list and thus is unable to import from these 10 companies.

It can import from other Indian companies that did not sign the Gilead agreement, however.

Other countries including Egypt have also refused to grant a patent to sofosbuvir, while least developed countries including Bangladesh do not have to grant patents.

Both Egypt and Bangladesh are also producing generic versions of sofosbuvir.

Malaysia faces another access-to-medicines obstacle.

Unlike India and several other developing countries that grant patents only on condition that the drug is a genuine invention (and not a mere discovery of a new form of a known substance, or only a discovery of a new use or property), Malaysia does not have the same standard in its law and is more liberal in granting drug patents.

Thus, sofosbuvir has already been granted a patent.

This blocks the local manufacture or import of generic versions of the drug.

However, international rules on intellectual property allow Malaysia to issue a compulsory licence or a government use order which then enables the Government or a private company to either manufacture or import the patented product.

The Government can thus consider this measure to enable access.

At the Kuala Lumpur workshop organised by Third World Network, South Centre and MTAAG (a group of patients), participants heard that the Health Ministry is planning to undertake clinical trials on sofosbuvir combined with another drug, daclatasvir.

This combination is the most suitable for Genotype 3 Hepatitis C patients, which most Malaysian patients are.

The ministry is exploring how to make the new Hepatitis C medicines available to Malaysians as soon and as cheaply as possible.

There are many hurdles to overcome, including deciding what is safe and effective, regulatory issues, production and import procedures, and – most problematic of all – the patent issue.

“The issue is how to get early access to these drugs, and to prepare the conditions for this,” said a Health Ministry official.

That gave hope to the many patient groups that were present.

“I’m very excited by this workshop where we have so many parties that matter,” said a representative of the patients.

“I have undergone the conventional treatment for Hepatitis C. It has such bad side-effects that I really can’t take it. With the new medicines, we see great hope. But we still don’t have access to them. Please make them available at a reasonable price as soon as possible. For us who are patients, each day counts.”

According to a senior Health Ministry official, there were 453,700 Malaysians living with Hepatitis C in 2009, which is 2.5% of the adult population. In 2014, 2,186 of these were notified to the health authorities.

Martin Khor (director@southcen tre.org) is executive director of the South Centre. The views expressed here are entirely his own.