Can philanthropy fill the gap left by the closure of USAID? Unlikely, say the experts — but it can do something.
It’s been a deeply turbulent three weeks for foreign aid, with the abrupt dismantling of USAID sending shockwaves through the sector. Funding for lifesaving programs has evaporated overnight, leaving many to wonder whether foundations will step in to fill the void.
On Wednesday, 12 February 2025, ITPC hosted a webinar exploring how Community-Led Monitoring (CLM) operates in diverse socio-economic and political contexts. Experts from HAC – Ukraine and NACOSA – South Africa shared insights on how CLM data is used for impactful change, transparency, and advocacy. This discussion highlighted the challenges and successes of CLM implementation.
You can also download the presentation slides and Q&A responses below.
The United States (US) government’s funding freeze is wreaking havoc across vital healthcare services in South Africa, creating an unprecedented crisis for people living with and affected by HIV and TB. A newly released compendium of frontline testimony by civil society exposes the deadly impact of halted support, with clinics shutting down, life-saving treatments interrupted and vulnerable communities abandoned. Read the full statement.
On Wednesday 5 February 2025, ITPC hosted a webinar with global health experts to discuss the current global health crisis, human rights, HIV science, development finance and community intelligence.
Panelists:
Solange Baptiste: Solange is the Executive Director of ITPC Global. With over 20 years of experience, she has dedicated her career to amplifying the voices of affected communities, ensuring they shape the decisions and policies that impact their lives.
Linda-Gail Bekker: Linda-Gail is a renowned South African physician and researcher. She serves as the Deputy Director of the Desmond Tutu HIV Centre and is a past president of the International AIDS Society.
Allan Maleche: Allan is a Kenyan human rights lawyer and the Executive Director of the Kenya Legal & Ethical Issues Network on HIV and AIDS (KELIN), focusing on health and human rights advocacy.
Veriano Terto: Veriano is a Brazilian health advocate associated with the Brazilian Interdisciplinary AIDS Association (ABIA), working on issues related to HIV/AIDS policy and human rights.
Harpinder Collacott: Harpinder is the CEO of 4ThoughtDigital, bringing over 20 years of experience in the development sector, with a focus on global financing for development.
Since 2022, Mpox has been reported in over 127 countries. On July 14, 2024, the World Health Organization (WHO) declared the ongoing Mpox outbreak a Public Health Emergency of International Concern (PHEIC). A day earlier, the Africa Centres for Disease Control and Prevention (Africa CDC) had declared it a Public Health Emergency of Continental Security (PHECS). Africa remains the most affected continent, with the Democratic Republic of Congo experiencing the highest burden.
As of December 15, 2024, nearly 14,000 individuals across 20 African countries have tested positive for Mpox, with 60 reported deaths.
To support affected communities, ITPC has developed a comprehensive factsheet that provides essential information about Mpox. This includes guidance on prevention, treatment education, and its specific impact on vulnerable populations, such as People Living with HIV (PLHIV), infants, and children.
The Mpox factsheet is currently available in English.
Translations in French, Spanish, Russian, and Arabic are forthcoming.
In 2023–2024, our partners in Kyrgyzstan and Belarus conducted an assessment of access to viral load and drug resistance testing. Our team has prepared a summary report based on data collected over the past year, providing an analysis of the current situation in both countries.
The report includes information on the availability of viral load and drug resistance tests, an analysis of the main barriers limiting access to testing and to obtaining results, and an evaluation of patients’ awareness of their test results. It also covers their understanding of the purpose and necessity of testing, as well as methods of monitoring the effectiveness of ART in Belarus and Kyrgyzstan.
The analysis of drug resistance test availability shows that in Belarus, only one drug resistance test is registered, and it is produced domestically. Meanwhile, no such test is registered in Kyrgyzstan. Belarus conducts about 1,000 tests annually, which meets the country’s needs according to clinical protocols. In Kyrgyzstan, an average of 200–300 tests are provided per year through a research and humanitarian project with an international partner (Russia).
Current clinical protocols in Belarus align with recommendations from the European AIDS Clinical Society (EACS), specifying who is recommended for drug resistance testing. In Kyrgyzstan, there is no clearly defined procedure for ordering and conducting drug resistance testing, although certain documents contain some testing recommendations.
Patient surveys in Belarus and Kyrgyzstan indicate that both countries maintain a high coverage rate for viral load testing: about 95% of all PLHIV in both countries (94% in Belarus and 96% in Kyrgyzstan) underwent testing at least once in the previous 12 months. Respondents in both countries demonstrated a relatively high level of knowledge about viral load tests – more than two-thirds understand that the purpose of viral load testing is to check whether ART is working. In both countries, the majority of respondents know (or have received) their most recent viral load test results (89% in Belarus and 81% in Kyrgyzstan). However, in one region of Kyrgyzstan, Jalal-Abad, PLHIV demonstrate a significantly lower level of knowledge about testing and interpreting results. In this region, respondents are statistically much less likely to receive or know their viral load test results, and doctors’ comment on these results less frequently than in the other two surveyed regions.
Overall, both countries are currently transitioning to dolutegravir-based regimens, which may reflect decreased interest from decision-makers in drug resistance testing, as well as fewer indications for such testing.
Key recommendations formulated based on the assessment emphasize the need for comprehensive national evaluations of patient awareness about their test results, as well as training healthcare personnel to effectively communicate laboratory diagnostic data to patients in both countries. Additionally, local NGOs are encouraged to conduct awareness-raising activities for patient communities aimed at increasing knowledge about the importance of ART effectiveness, the causes of drug resistance, its diagnosis, and the importance of timely detection of resistance to specific medications.
Community monitoring on the availability of viral load and drug resistance testing in the Republic of Kyrgyzstan and the Republic of Belarus in 2023.
This report was prepared with the methodological and technical support of the International Treatment Preparedness Coalition (ITPC GLOBAL) and with financial support from the Robert Carr Fund.
The title of the Universal
Declaration of Human Rights
makes it clear. Our rights are
universal. When it comes to
these rights, no one is excluded.
Yet, when it comes to access to
medicines and other essential
health tools, the world has yet to
recognize the universality of our
rights. People are denied access
to affordable, lifesaving health
technologies based on where
they live. This is a violation of
human rights, and it holds back
progress in ending AIDS as a
public health threat.
I first became involved in the
response to HIV in my home
country of Morocco, motivated
by a commitment to supporting
the gay community and
promoting principles of equality
and nondiscrimination. Our work
was an affirmation of the equal value of every life. There was
no treatment then, and so we
worked to raise awareness of HIV
prevention among gay men and
other men who have sex with
men.
Then came an amazing
medical breakthrough. At the
International AIDS Conference in
Vancouver in 1996, we learned
that HIV need not be invariably
fatal, and there were effective
treatments that could prevent
the progression of AIDS.
But now the people I worked
with faced another violation of
rights, another exclusion. This
time, it was because of where
they lived: HIV treatment was
almost exclusively available in
North America and western
Europe.
Activists united to demand
that the HIV response chart
a new way forward on access
to lifesaving medicines.
The emergence of generic
manufacturers for antiretroviral
medicines meant there was a
path to ensure worldwide access
to affordable medicines.
The 2001 Doha Declaration on
the World Trade Organization
Agreement on Trade-related
Aspects of Intellectual Property
Rights (TRIPS) and public
health emphatically stated
that patents should not tie the
hands of countries seeking to
address public health threats.
Afterwards, we saw countries
issuing compulsory licences for
HIV medicines, enabling the
purchase of more affordable
generic versions. The vision
of universal access to HIV
medicines, in which the fruits of
technology would be available
to all, wherever a person lived,
at last seemed realizable.
Today, however, access to
new HIV medicines, including
long-acting medicine that
requires only two shots a year,
is being denied to people
based on where they live. Large
multinational pharmaceutical
companies are determining
which countries will have access
to affordable HIV medicines and
which will be denied them. They
are denying access to many
countries in the Global South,
including countries with high
HIV prevalence and countries
in which numbers of new HIV
infections are on the rise.
The justification for excluding
these countries is that they are
“middle-income”, an arbitrary
measure based on categorizatcategorizations
made by international finance
institutions that were never
developed to determine access
to medicines. In fact, the people
most affected by HIV in many of
these countries are some of the
most economically deprived and
socially excluded people on the
planet.
So now we have early access to
HIV medicines in high-income
countries because that is where
the greatest profits are made
and where governments can
afford those prices; late and
incomplete access in lower income countries, through
voluntary licences; and access
denied in many middle-income
countries, which are explicitly prevented from purchasing
products from generic producers
granted those voluntary licences.
The voluntary nature of the
current approach to medicines
access is an inherent and fatal
flaw. People, regardless of where
they live, should never have to
depend on the determination
of a business to obtain the
medicines they need to survive.
And exclusion of countries
undermines the HIV response
globally. AIDS cannot be ended
unless it is ended everywhere.
Using the flexibilities in the
World Trade Organization
Agreement on Trade-related
Aspects of Intellectual Property
Rights (TRIPS), rather than
depending on the whims of
individual pharmaceutical
companies, constitutes the
path towards equitable access
to medicines. Countries have
the right to override patent
protections through the use
of compulsory licensing to
ensure access to medicines and
vaccines needed to address
high-priority health problems.
Claims by the pharmaceutical
industry that compulsory licences
represent an unwarranted theft
of their intellectual property
are false, because compulsory
licences still include the payment
of royalties to the patent-holder.
Just as no one should be
obstructed from access to
lifesaving medicines because of
their sexuality, no one should
be excluded because of their
nationality. Ensuring access
to affordable medicines for
everyone, everywhere, is human
rights work—and it is essential
for the world to be able to end
AIDS as a public health threat.
Jointly, they called on the Thai government to be firm in its stance against TRIPS+ provisions during free trade agreement (FTA) negotiations with the European Free Trade Association (EFTA)
This week (16 October 2024), a ministerial meeting was held between the European Free Trade Association (EFTA) and Thailand, to discuss the Free Trade Agreement (FTA) negotiations in Thailand. Civil society in Thailand and Switzerland share concerns that Thailand will be pressured to accept conditions on intellectual property (IP) rights that will affect access to medicines to conclude the negotiations by the end of the year, as planned by Thailand’s Paethongtarn government.
There have already been 10 rounds of FTA negotiations between Thailand and the European Free Trade Association (EFTA) countries (Iceland, Liechtenstein, Norway, and Switzerland), but issues on IP rights and access to medicines have not been resolved – despite intense negotiations. Thailand’s negotiating representatives have taken a stand – they will not accept provisions that are more stringent than those of the World Trade Organization’s TRIPS Agreement, because they would have a negative effect access to medicines – but EFTA countries continue to demand stricter protection of IP rights than the TRIPS Agreement (these measures, which surpass those of the TRIPS agreement, are known as TRIPS+).
Mr. Chalermsak Kittitrakul, Project Manager for Access to Medicines at the Thai Network of People Living with HIV/AIDS (TNP+), expressed concern about a confidential discussion between the EFTA ministerial delegation and the Thai Minister of Commerce held during the meeting. Although the Thai negotiating delegation has always been clear about protecting access to medicines, the Minister might have been asked to pressure or order Thailand’s negotiators to accept issues that will have serious impacts for Thailand.
“The EFTA countries may use the same method for negotiating the FTA as they did with India, by ending the negotiation with conditions that allow IP rights to be reviewed again, “ explained Chalermsak, “EFTA countries should stop demanding IP obligations that go beyond the TRIPS Agreement, such as restricting the use of compulsory licensing, and even having conditions that allow for re-negotiation of IP issues after the deal has been concluded and signed.”
Research on the impact of FTAs including the IP rights requirement that EFTA is demanding found that expenses for medicines in Thailand will increase by 25,000 million to 72,000 million Baht (or US $ 753 thousand to 2,171 million) if it signs the FTA with provisions on data exclusivity and patent term extension.
Mr. Patrick Durisch, a representative from Public Eye, a Swiss civil society organization that monitors the FTA negotiations between the EU, the EFTA, and low- and middle-income countries, added “Thailand has fully complied with the TRIPS Agreement. But the EFTA countries, especially Switzerland, which is home to many multinational pharmaceutical companies, have not stopped asking Thailand for IP protection that is stricter than the TRIPS Agreement in the FTA negotiation, such as data exclusivity, patent term extension, and restrictions on the use of public health safeguard measures.”.
Ms. Kannikar Kijtiwatchakul, who is Vice Chairperson of FTA Watch, asked Thailand’s government, including Prime Minister Paethongtarn Shinawatra and Mr. Phumtham Vejjayachai, Deputy Prime Minister and Minister of Commerce, to be aware that the FTA could have a significant impact on the country’s universal health coverage scheme: if medicines become significantly more expensive, the Thai government will not be able to use legal mechanisms to negotiate or procure drugs at affordable prices.
“The successes of the universal health coverage policy have been built by the Pheu Thai Party since it was the Thai Rak Thai Party. The policy that the Prime Minister and the Pheu Thai Party is currently prioritizing will become the scheme that fails to truly take care of the people – and it will also destroy the government’s space for issuing public policies that safeguard people’s health benefits. Therefore, the government must support the Thai negotiators in keeping their firm stance, and not to accept TRIPS+ provisions. This FTA is very crucial to the EFTA – do not allow it to force the conclusion of this deal by the end of 2024 – or to threaten or pressure the Thai negotiators, because EFTA really wants to close the deal as soon as possible. The Paethongtarn government should be well aware of EFTA’s agenda – and Thailand’s propositions,” Kannikar said.
In September, a Study on Investment and International Trade under the Framework of Human Rights, Economic Justice, and Environmental Protection was launched by the Foreign Affairs Committee of the House of Representatives of Thailand. It recommended that “…the negotiations should maintain policy space in enacting measures to protect consumer rights, promote access to medicines, and safeguard agricultural rights and biological resources, including avoiding IP protection [that is] more stringent than international agreements, so that international trade will bring sustainable benefits to all sectors of the society.”
“Unfortunately, this is not an isolated event,” said Othoman Mellouk, who is the Access to Diagnostics & Medicines Lead at the International Treatment Preparedness Coalition,
“We have seen a similar push by EFTA in many other countries, including India. These TRIPS+ provisions, which EFTA systematically lobbies for, will have long-term, negative impacts on people’s access to essential medicines and threaten sustainability of Thailand’s existing local manufacturing capacity.”
The Thai Network of People Living with HIV/AIDS (TNP+) filed an opposition to a patent application filed by the U.S.-based pharmaceutical giant Gilead Sciences and Ireland-based Janssen for the combination of rilpivirine (RPV) and tenofovir disoproxil fumarate (TDF). The big pharma companies are seeking to extend its patent monopoly on the drug combination until 2031.
Rilpivirine is an ARV recommended in Thailand’s HIV national guidelines as an alternative treatment for people living with HIV who cannot use some ARVs (efavirenz and dolutegravir) due to side effects.
“This is an essential drug for people living with HIV, especially those who have few options for drugs to stop the virus from spreading and prevent further transmission,” said Chalermsak Kittitrakul, Project Manager for Access to Medicines at TNP+. “Gilead’s and Janssen’s patent monopoly extension would be disastrous for people living with HIV in Thailand. We need to take a stand against big pharma and their exploitation tactics which prioritize their profits over public health.”
Evergreening is a common strategy used by pharmaceutical companies, who obtain secondary patents on different aspects of known medicines or minor modifications of an old drug. This enables them to continue having the exclusive rights to sell medicines or vaccines, and prevents production of affordable generic versions.
“We filed the opposition because this patent application does not comply with the Thai patent law,” said Kittitrakul. “This secondary patent application does not pertain to any novelty or innovation in RPV and TDF,” adding that they are not new drugs – and that combining them does not have any new effects.
People living with HIV in Thailand currently take TDF and RPV as separate pills.
If the patent is permitted, Kittitrakul said it would artificially extend Gilead’s and Janssen’s monopoly on the drug, limiting opportunities for local manufacturing of generic versions of TDF and RPV, even though Gilead and Janssen do not currently produce and market TDF and RPV in Thailand. The patent may also prevent production and availability of RPV in combination with other ARVs in the future – or prevent TDF and RPV drugs from being combined in one pill, so it is more convenient for people living with HIV.
If granted, this patent extension would prevent and delay production and importation of TDF and RPV. According to Kittitrakul, Gilead’s and Janssen’s efforts to unlawfully extend this patent undermines efforts to combat HIV/AIDS in Thailand. “If we can stop pharmaceutical companies like Gilead and Janssen from continuing to extend their unlawful, profit-motivated monopolies, we can ensure people living with HIV in Thailand have a chance at a healthy, long life,” he said.
Vietnam’s Network of People Living With HIV (VNP+), a Make Medicines Affordable (MMA) partner, is working to improve access to, and affordability of long-acting HIV prevention and treatment. In September 2024, VNP+ filed a pre-grant opposition to a patent application on long-acting cabotegravir (CAB-LA), an injectable antiretroviral recommended by the World Health Organization (WHO) for HIV prevention (and as part of long-acting HIV treatment).
If granted, the patent application on CAB-LA would artificially extend ViiV Healthcare’s monopoly on the drug (a practice known as evergreening), limiting opportunities for local manufacturing of CAB-LA, and undermining efforts to combat HIV/AIDS in Vietnam.
According to Dong Dang Do, Chairman of VNP+, Viiv’s attempt to extend the patent on CAB-LA is “a common strategy of the pharmaceutical industry to maximize profits – even if it limits access to important and affordable treatments. The monopoly on CAB-LA could have a significant impact on Vietnam’s goals of ending AIDS by 2030.”
In clinical trials, CAB-LA was 79% more effective at preventing HIV than oral pre-exposure prophylaxis (PrEP) – mainly because study participants missed doses of oral PrEP, while ’protection from CAB-LA injections lasts for two months. But access to CAB-LA is limited by
ViiV Healthcare’s high prices: in the United States, CAB-LA is $22,200 per person, per year (PPPY), and in the United Kingdom, it is £7100 PPPY. In most low- and middle-income countries, including Vietnam, ViiV’s price for CAB-LA remains secretive.
Generic versions of CAB-LA could be far more affordable than what ViiV is charging donors and low-income countries (~ $180 USD PPPY). An analysis from Clinton Health Access Initiative estimates that generic versions of CAB-LA could be profitably mass-produced for $14 to $40 USD PPPY, which is 500 times lower than ViiV’s US price.
“If ViiV is successful in evergreening CAB-LA, it will lead to higher drug prices and limited access to this essential drug, which could impact existing HIV prevention and treatment programs,” said Do.
VNP+’s patent opposition filing states that the patent grant does not meet patentability requirements. Specifically, VNP+ states that ViiV Healthcare’s claimed patent application lacks novelty and inventive steps, which are essential for a patent under the country’s current laws. Vietnam’s National Office of Intellectual Property is currently reviewing reports submitted by VNP+ regarding the opposition of the patent grant. The office is consulting with both parties and is expected to announce its decision in the coming months.
“We need to have solutions promoting the local production of generic drugs and improving drug pricing regulations to reduce the negative impact of these monopolies,” said Do, adding that intellectual property and pharmaceutical policies should consider balancing the interests of companies with ensuring patients’ access to medicines.
Civil society organizations across the Global South are blasting the U.S.-based pharmaceutical company Gilead Sciences for its lenacapavir (LEN) voluntary license (VL), which allows six pharmaceutical manufacturers to make and sell generic LEN in 120 countries. All other countries must purchase LEN from Gilead, at whatever price the company chooses to set, because the generics manufacturers that signed the VL can only sell LEN to the 120 countries included in the VL.
LEN is a groundbreaking, long-acting method of HIV prevention, given as twice-yearly injections. It has prevented nearly all HIV infections in two phase III clinical trials, and it could prevent millions of new HIV infections, if it was affordable and available everywhere. However, public health experts from the Global South have stated the VL will make the drug inaccessible to some people who need it the most, despite claims from Gilead that its VL would “enable broad, sustainable access to lenacapavir … and align(s) with Gilead’s vision of ending the HIV epidemic for everyone, everywhere.”
Gilead’s VL will prevent millions of people, including those most vulnerable to HIV, from accessing LEN in low- and middle-income countries (LMIC) such as Algeria, Argentina, Brazil, Colombia, El Salvador, Guatemala, Peru, and Malaysia, among others. UNAIDS called this exclusion “deeply worrying,” since these and other countries which Gilead has excluded from the VL must pay whatever Gilead demands for LEN. The price is likely to be far too high, making it inaccessible from those who could benefit from the drug. In the US, where LEN is approved as part of treatment for multidrug-resistant HIV, Gilead charges over USD $40,000 per person per year for the drug.
Notably, Brazil was excluded from the VL, despite the country’s contributions to clinical trials. Although the World Bank classifies Brazil as an upper-middle-income country, the Brazilian Interdisciplinary AIDS Association (ABIA) states that this ignores Brazil’s deep socio-economic inequalities.
Brazil contributed to the clinical development of LEN by hosting the PURPOSE-2 trial. According to the Declaration of Helsinki, companies that conduct clinical trials should have a plan to ensure they benefit the communities where they are conducted. But drug companies often limit the benefits to the people who participate in trials for a limited amount of time. “I think it’s perverse that Brazil contributed to clinical trials and we are not even considered in the VL,” commented Veriano Terto Jr., Vice President of ABIA. “Our bodies served in these clinical trials and we are not even being [included]. Gilead should reconsider this in an act of solidarity.”
As Timothy Wafula, Programme Manager with the Kenya Legal & Ethical Issues Network on HIV and AIDS (KELIN) explained, excluding nearly half of all countries from the VL “directly undermines the progress aimed to make equitable healthcare access.” He added that excluding key LMICs from the LEN VL “worsens existing health disparities by denying people access to a powerful HIV prevention and treatment tool, particularly where healthcare access gaps are widest.”
Global health experts and civil society organizations agree that access to effective, long-acting HIV prevention is already limited, and that equitable access to LEN would be a gamechanger.
Over 30 million people worldwide take HIV treatment every day. By limiting access in excluded countries to a prevention method that could change lives, the VL goes against the principle of fair and equal access.
Othmane Marrakchi, Advocacy Officer at ITPC-MENA, Morocco, stated that people in Algeria, Lebanon, Jordan, Iran and Iraq will not have access to LEN, since these countries are excluded from Gilead’s VL. “These restrictions hinder progress in HIV prevention throughout the region,” he shared.
“We are talking about a twice-yearly dosing,” said Marrakchi. “This is revolutionary and could end many struggles people face with HIV. If lenacapavir were easily accessible … it could truly change lives. With just two doses a year, it would be much easier for people to prevent HIV, especially those with limited access to regular healthcare. This could lower new HIV cases and improve the lives of people at risk,” he said.
Instead, the VL will create a gap in technology, excluding middle-income countries from accessing groundbreaking long-lasting treatments, said Othoman Mellouk, who is the Access to Diagnostics & Medicines Lead at the International Treatment Preparedness Coalition. “We will have rich and poor countries who will access them [technology] and in the middle, we will have people who will never have access until the patent expires in 20 years. If we don’t pay attention we will create this gap.”
Civil society organizations have been united in calls for Gilead to expand the geographic scope of the VL and the number of manufacturers who are included in it. Gilead granted licenses to only six manufacturers to make and sell generic LEN – none of which are in Sub-Saharan Africa, which bears the world’s highest burden of HIV. Public health advocates say they are troubled by Gilead’s decision not to grant a license to manufacturers in Sub-Saharan Africa.
“By relying entirely on manufacturers outside of Sub-Saharan Africa, the VL risks slowing access to LEN in Africa, and perpetuates over-dependence on external suppliers with limited understanding of local needs. Local production could drastically reduce costs, improve supply chain resilience and ensure that the treatment reaches those who need it with minimal delays,” said Wafula.
UNAIDS has stated that manufacturing LEN in African countries with the highest HIV rates is crucial for sustainability, and urged Gilead to include manufacturers in countries with strong production capacity, such as South Africa. “If we really want to boost [medication] production in Africa, we should see two or three manufacturers in Africa,” said Mellouk.
Although Thailand is included in the LEN VL, the Thai Network of People Living with HIV/AIDS (TNP+) still expressed opposition to it. “TNP+ decided to join the global movement on patent oppositions, because the [Gilead’s] patent applications are unmerited and do not meet patentability criteria,” said Chalermsak Kittitrakul, TNP+’s Project Manager for Access to Medicines.
Marrakchi explained that countries in the Global South oppose Gilead’s LEN VL, due to the inequity perpetuated by the license, which “exploits communities in one part of the world to justify restrictions in others. Gilead’s ‘access strategy’ claims to support access by including nearly all of Africa in the license, but we, as African advocates, say ‘not in our name.’ We don’t support being used as proof of Gilead’s goodwill when people in Latin America, Asia and MENA are left without access to LEN,” he said. “HIV knows no borders, so why should life-saving products have them?”
Advocates maintain that creating equitable health solutions and increasing accessibility of promising long-lasting HIV drugs such as LEN can support the UN goal of ending AIDS by 2030.
For more information on this issue, please refer to statements by the following organizations regarding Gilead’s voluntary license of lenacapavir:
Civil society groups in Indonesia have raised concerns over proposed amendments to the Patent Law, which they argue serve the interests of pharmaceutical companies at the expense of public health in Indonesia. The Make Medicines Affordable campaign, represented by the Indonesia AIDS Coalition (IAC), along with Indonesia for Global Justice (IGJ) and the Coalition for Affordable Medicines (Koalisi Obat Murah – KOM), have strongly criticized the Patent Bill that has undergone deliberations in the House of Representatives and was approved in a Plenary Meeting on September 30, 2024 — just one day before the transition to new legislative members on October 1, 2024. The bill introduces amendments to the Indonesian Patent Act (Law 13/2016), which civil society groups fear could undermine public health, especially for those in need of life-saving treatments.
The concern arises from provisions within the Patent Bill — particularly Article 4(f), Article 19(1), and Article 93 — that could lead to the extension of pharma companies’ patent monopolies and the weakening of the Government of Indonesia’s mechanisms to ensure prompt access to essential medicines. The patent law amendment, which covers 48 articles, has the potential to open the door for patent evergreening, according to Aditya Wardhana, IAC’s Executive Director.
Evergreening is a common strategy used by pharmaceutical companies to extend the life of patents by applying for secondary patents over different aspects of known medicine or over minor modifications of an old drug. Through this tactic, pharmaceutical companies can extend their patents, thereby continuing to profit from medicines or vaccines while preventing the manufacture of generic versions.
“Article 4, point f, [in the Patent Bill] initially excluded the new use of an existing drug or new forms of known compounds without a significant increase in efficacy from being considered inventions …but in the new Patent Bill, this practice is permitted,” said Wardhana.
The bill also introduces what are known as method patents through Article 19 (1), which is not known in the TRIPS Agreement and Indonesia isn’t obliged to implement.
Agung Prakoso, Program Coordinator for Health Issues at IGJ, said that the amendment serves the monopolistic interests of pharmaceutical companies and “represents a step backward …obstructing public access to medicines.” He urged that the provisions in Article 4, point f, be restored to their original form in Law 13/ 2016 concerning patents.
Prakoso further stated that the government, notably the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights, should not focus on increasing the number of patents, karena hal itu bukan merupakan tanggung jawab dari DGIP dan justru kerap kali didorong oleh kepentingan bisnis yang dapat merugikan pasien.
Prakoso further emphasized that the government, particularly the Directorate General of Intellectual Property (DGIP) under the Ministry of Law and Human Rights, should not prioritize increasing the number of patents, as that is not the responsibility of the DGIP and is often driven by business interests that could potentially harm patients.
Indonesian civil society groups further state that the bill also weakens mechanisms that the government can use to ensure public access to medicines. The bill removes Article 93, which concerns compulsory licensing for pharmaceutical products. Compulsory licensing serves as a safeguard against monopolistic practices by pharmaceutical companies.
Civil society groups note numerous instances where pharmaceutical companies register patents simply to block others, including local manufacturers, from utilizing the technology, while at the same time failing to use these patents locally. For example, in some instances, pharmaceutical companies may not introduce the relevant medicine in the country at all, which then makes the drug completely inaccessible to people who need it.
Aditya Wardhana, Executive Director of IAC, explained how patent blocking is a harmful practice. “If a pharma company engages in blocking, local producers can apply for a compulsory license on the patent. The compulsory license can also be used as a bargaining chip by the government, as patent-holding companies often grant voluntary licenses to prevent the issuance of a compulsory license,” he said.
Civil society groups state that the Patent Bill will impose financial burdens on the government as monopolies on drugs intensify, affecting the healthcare budget.
According to Agung Prakoso, Program Coordinator for Health Issues at IGJ, the strong vested interest by pharmaceutical companies in the patent bill amendments will lead to “an economic burden for the public and the government, which will have to bear the cost of expensive medicines in the national health insurance and/or national HIV and TB program.”
Civil society groups have previously successfully advocated for increased access to essential medicines, which has provided significant cost savings to the government. For example, IAC’s success in pushing for generic competition led to lowering the price of HIV medication Tenofovir Lamivudine Efavirenz (TLE), by 48% from 2016 to 2020. This continues to save the Indonesian government US $8 million annually, while increasing the number of PLHIVs accessing the medication.
IAC launched a petition expressing the organization’s concern regarding the amendments proposed to the Indonesian Patent Act of 2016. The petition states the bill amendments will extend patent monopolies and further restrict access to affordable medicines, including newer, life-saving treatments, which may exacerbate Indonesia’s current public health challenges, such as its exceptionally high rate of tuberculosis. Indonesia is included in all three of the WHO’s lists of high-burden countries for TB, HIV-associated TB, and drug-resistant TB. The petition was signed by global civil society organizations, who backed Indonesian groups in decrying the proposed bill amendments.
“The discussion of this Patent Bill has not only been conducted in a closed manner but also rushed, without meaningful participation from civil society groups. As a result, the Bill prioritizes the business interests of patent holders while neglecting patients’ rights,” said Prakoso.
The signees request that the government reconsider the proposed changes and engage in a transparent, inclusive consultation process with all relevant stakeholders, especially affected communities, civil society organizations, relevant ministries, and public health experts.
Click here to read press releases by the Indonesia AIDS Coalition (IAC).