The Indonesian patent club – and its impact on Hep C treatment

Communities are refusing to accept patent abuse – challenging unmerited patents, and finding ways around them in the meantime.

Community groups, including networks of people living with HIV in Indonesia, are becoming experts in intellectual property (IP), and unveiling the abuses that pharmaceuticals have been able to get away with when left unchallenged.

A coalition of representatives called the ‘community patent club’ was established by the Indonesian AIDS Coalition (IAC) and other like minded people, to address issues around lack of access to medicines and diagnostics, to share knowledge and take collective action. Members of the club include people living with HIV, HIV and human rights activists, patient groups, lawyers, media and legal aid workers.

While largely based in Jakarta, the club meets both in person and online, in order to extend its reach beyond the capital. Community members who are knowledgeable in IP regularly run sessions for new members. During monthly discussion forums, topics are selected to first ensure that IP law and the country’s patent process are understood, and then to use this knowledge to analyse the impact on treatment access. Where unmerited patents exist, they can then be challenged, whether already granted or in progress. The club is very active and maintains contact through Facebook and WhatsApp groups in between sessions, and keeps the website Koalisi Obat Murah up-to-date, sharing knowledge beyond the club itself.

Extending hepatitis C treatment

Nearly 9.5 million people are estimated to be living with hepatitis C (HCV) in Indonesia. The patent club has been focused on increasing access to sofosbuvir and other direct-acting antivirals (DAA)  such as ledipasvir, daclatasvir, essential drugs in the treatment of HCV. The recommended treatment regimens have better efficacy and fewer side-effects, curing patients in a matter of weeks, with a 12 week course being the typical prescription.

Gilead Sciences has one patent granted and two pending on sofosbuvir in Indonesia. Due to lobbying by community groups, Indonesia is listed in Gilead’s voluntary license, which allows the government to procure the cheaper, generic version from registered suppliers in India. As a result of the constant pressure and lobbying by IAC and other patent club members, combined with regional expertize and support from APN+, the registration process of generic sofosbuvir was completed within a short period of time to make this drug available locally. While this goes some way to increasing access, IAC and club representatives are continuing talks with the patent office and the relevant ministries, to ensure that any unmerited, evergreening patents aren’t granted, and that TRIPS flexibilities are used to ensure access. The cost for generic sofosbuvir is $280 USD per bottle and the government has started a free treatment program in five cities with the target of treating 6,000 people. The program is providing a sofosbuvir, simeprevir and ribavirin combination. For those who can not use simeprevir, daclatasvir is an alternative. This is being donated by the Clinton Health Access Initiative (CHAI), which has committed to provide daclatasvir for an additional 3,000 people.

“The voluntary license in place is the first step towards increased access as it means the treatment costs less than if compared to countries where a patent is granted and no license is in place,” says Shiba Phurailatpam, Director of the Asia Pacific Network of People Living with HIV/AIDS (APN+) . “However, the numbers Indonesia can reach doesn’t go far enough. Bringing in more generic companies combined with local production would create competition among generic suppliers and lower the cost even further, so more of the 9.5 million people in need could be treated.”

Refusing to wait

The club’s activity has drawn significant attention from the public and media, through its events, protests and online petitions. Government departments have also taken note, including the Ministry of Health, which has accepted many of the arguments, recognizing the impact on public health.

Prior to the procurement of Indian generic sofosbuvir being approved by the government, the Ministry of Health, in partnership with a local hospital and a national pharmaceutical company, started sourcing generic sofosbuvir from India under a ‘special access scheme’ which was made available at one hospital in response to an online petition by the coalition. Due to this outcome the action was recognised as one of‘s most successful campaigns of 2015. It also shows the power of community action, and that these types of actions are deemed legitimate.

Even after the official decision to procure from India, the IAC, recognising that there would be a gap in treatment access while registration was completed, set up the ‘Indonesian buyers club’. It was launched in December 2015 by organizing a press conference. With millions of people still living with HCV, and the cost of treatment under the voluntary license still being too high to treat everyone in need, providing other ways for people to obtain the cure may still be necessary.

Amendment of Indonesian Patent law

With this maze of treatment costs and licenses to navigate, IAC is advocating for a review of the current Indonesian patent law, so that all TRIPS flexibilities are incorporated in the law. This includes compulsory licensing which is at the government’s disposal, and which can bring in real competition. The revised draft of the patent law is still pending.

Our campaign partner

The Asia Pacific Network (APN+) has members in 30 countries. It is the campaign partner of Make Medicines Affordable in Myanmar, Indonesia and Vietnam. The national partners are the Indonesian AIDS coalition (IAC), the Myanmar Positive Group (MPG) and the Vietnam Network of People Living with HIV (VNP+). All three partners are campaigning on access to affordable HIV and HCV treatment, with a current spotlight on sofosbuvir and other direct acting antivirals (DAA).

Key activities of the project include building the capacity of community on intellectual property rights, free trade agreements and their impact on access to medicines, lobbying key government officials and other stakeholders including media, and raising awareness of intellectual property rights and access to medicines.