Initiative for Medicines, Access, and Knowledge

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Initiative for Medicines, Access, and Knowledge
AbbreviationI-MAK
HeadquartersUnited States
Executive directors
 Priti Krishtel and Tahir Amin
Website www.i-mak.org

The Initiative for Medicines, Access, and Knowledge, known as I-MAK, is a U.S.-based global 501(c)(3) organization that advocates in the public interest for affordable access to medicines, [1] and a medicines system that is more inclusive of patients and the public. [2]

Contents

I-MAK's work has been featured in national and international media outlets, including The New York Times, The Wall Street Journal, The Financial Times, Fox Business, Bloomberg, the Washington Post, Forbes, PBS, Salon, and STAT News.

Organization

I-MAK is a team of lawyers, scientists, and health policy and market dynamics experts who advocate for affordable medications, [3] and prioritize public good over private interests in the medicines system. [4]

I-MAK was founded in 2006 by lawyers Priti Krishtel, experienced in the global access to medicines movement, and Tahir Amin, experienced in intellectual property law. [3] I-MAK has been supported by individuals and organizations aiming to lower the cost of prescription drugs, increase access to medicines, and make systems more inclusive and equitable, [1] [5] [6] including the Ford Foundation, the Laura and John Arnold Foundation, Médecins Sans Frontières/Doctors Without Borders, the Commonwealth Fund, Open Society Foundation, Kaiser Permanente, Echoing Green, the Calamus Foundation DE, the Mont Fund, the Palayam Foundation, Ashoka Foundation, and the Economic Security Project. [7]

Past activities

In the initial days, I-MAK partnered with humanitarian and community-led organizations to launch legal challenges to hepatitis C and HIV drugs in several countries, [8] and successfully filed challenges against pharmaceutical patents that were determined to be unmerited. [9] [10] [11] During this time, I-MAK worked alongside Nobel Peace Prize recipient Médecins Sans, Frontières/Doctors Without Borders, and patient networks to file patent challenges on behalf of low-income patients to ensure they received access to lifesaving medicines. [7] [12]

I-MAK's work has decreased the cost of drugs and increased access to medicines for millions of patients. [11] [5] By 2019, I-MAK had worked on patent law [13] for 33 treatments for 16 diseases, including cancer, [14] HIV, [15] hepatitis C, [16] and diabetes. [3] I-MAK has served in advisory capacities to patient groups, the European Patent Office, UNITAID, the Clinton Foundation, Médecins Sans Frontières/Doctors Without Borders, Gavi the Vaccine Alliance, and the World Health Organization. [7] [12]

Current activities

In 2022, I-MAK launched a publicly accessible database showing drug patent data information on the top selling drugs in the U.S. The database was used by the New York Times in a 2023 investigation into AbbVie's patenting strategies on Humira. [17]

As of October 2022, I-MAK provides research, education, and policy solutions about the medicines system – the system encompassing drug development to drug access – through a process that involves various affected stakeholders called Participatory Changemaking. [12]

In 2021, I-MAK called on the U.S administration and federal agencies to take action to promote competition and advance equity across government and update the patent system in the public's interest. Citing I-MAK's research and attention to the issue, in December 2021, the United States House Committee on Oversight and Reform released an investigation on drug pricing, finding that pharmaceutical companies engage in abusive patenting practices to extend their monopolies in the United States. [18]

In 2022, the New York Times Editorial Board cited I-MAK's publications supporting patent system reform and called on Congress and the United States Patent and Trademark Office Director Kathi Vidal to "modernize and fortify" the patent system. [12]

During the COVID-19 pandemic, I-MAK has been a vocal proponent for more equitable distribution of vaccines and treatments [19] and racial equity in vaccine rollout. [20] [21] I-MAK joined global health advocates in calling for a waiver to the World Trade Organization's TRIPS agreement so that intellectual property did not inhibit manufacturing and access [22] to COVID-19 technologies, emphasizing the amount of public funding that contributed to vaccine and treatment development. [23] [24]

Related Research Articles

<span class="mw-page-title-main">Hepatitis</span> Inflammation of the liver

Hepatitis is inflammation of the liver tissue. Some people or animals with hepatitis have no symptoms, whereas others develop yellow discoloration of the skin and whites of the eyes (jaundice), poor appetite, vomiting, tiredness, abdominal pain, and diarrhea. Hepatitis is acute if it resolves within six months, and chronic if it lasts longer than six months. Acute hepatitis can resolve on its own, progress to chronic hepatitis, or (rarely) result in acute liver failure. Chronic hepatitis may progress to scarring of the liver (cirrhosis), liver failure, and liver cancer.

<span class="mw-page-title-main">Antiviral drug</span> Medication used to treat a viral infection

Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Antiviral drugs are a class of antimicrobials, a larger group which also includes antibiotic, antifungal and antiparasitic drugs, or antiviral drugs based on monoclonal antibodies. Most antivirals are considered relatively harmless to the host, and therefore can be used to treat infections. They should be distinguished from virucides, which are not medication but deactivate or destroy virus particles, either inside or outside the body. Natural virucides are produced by some plants such as eucalyptus and Australian tea trees.

<span class="mw-page-title-main">Hepatitis C</span> Human viral infection

Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection period, people often have mild or no symptoms. Early symptoms can include fever, dark urine, abdominal pain, and yellow tinged skin. The virus persists in the liver, becoming chronic, in about 70% of those initially infected. Early on, chronic infection typically has no symptoms. Over many years however, it often leads to liver disease and occasionally cirrhosis. In some cases, those with cirrhosis will develop serious complications such as liver failure, liver cancer, or dilated blood vessels in the esophagus and stomach.

The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multiple drugs that act on different viral targets is known as highly active antiretroviral therapy (HAART). HAART decreases the patient's total burden of HIV, maintains function of the immune system, and prevents opportunistic infections that often lead to death. HAART also prevents the transmission of HIV between serodiscordant same-sex and opposite-sex partners so long as the HIV-positive partner maintains an undetectable viral load.

<span class="mw-page-title-main">Pharmaceutical industry</span> Industry involved with discovery, development, production and marketing of drugs

The pharmaceutical industry is an industry in medicine that discovers, develops, produces, and markets pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure and prevent diseases, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%.

<span class="mw-page-title-main">Aciclovir</span> Antiviral medication used against herpes, chickenpox, and shingles

Aciclovir, also known as acyclovir, is an antiviral medication. It is primarily used for the treatment of herpes simplex virus infections, chickenpox, and shingles. Other uses include prevention of cytomegalovirus infections following transplant and severe complications of Epstein–Barr virus infection. It can be taken by mouth, applied as a cream, or injected.

<span class="mw-page-title-main">Gilead Sciences</span> American pharmaceutical company

Gilead Sciences, Inc. is an American biopharmaceutical company headquartered in Foster City, California that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19, including ledipasvir/sofosbuvir and sofosbuvir. Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.

<span class="mw-page-title-main">Rimantadine</span> Drug used to treat influenzavirus A infection

Rimantadine is an orally administered antiviral drug used to treat, and in rare cases prevent, influenzavirus A infection. When taken within one to two days of developing symptoms, rimantadine can shorten the duration and moderate the severity of influenza. Rimantadine can mitigate symptoms, including fever. Both rimantadine and the similar drug amantadine are derivates of adamantane. Rimantadine is found to be more effective than amantadine because when used the patient displays fewer symptoms. Rimantadine was approved by the Food and Drug Administration (FDA) in 1994.

<span class="mw-page-title-main">Tenofovir disoproxil</span> Antiviral drug used to treat or prevent HIV and hepatitis infections

Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for prevention of HIV/AIDS among those at high risk before exposure, and after a needlestick injury or other potential exposure. It is sold both by itself and together in combinations such as emtricitabine/tenofovir, efavirenz/emtricitabine/tenofovir, and elvitegravir/cobicistat/emtricitabine/tenofovir. It does not cure HIV/AIDS or hepatitis B. It is available by mouth as a tablet or powder.

<span class="mw-page-title-main">Emtricitabine/tenofovir</span> Drug combination for HIV/AIDS prophylaxis and treatment

Emtricitabine/tenofovir, sold under the brand name Truvada among others, is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disoproxil. For treatment, it must be used in combination with other antiretroviral medications. For prevention before exposure, in those who are at high risk, it is recommended along with safer sex practices. It does not cure HIV/AIDS. Emtricitabine/tenofovir is taken by mouth.

<span class="mw-page-title-main">Sofosbuvir</span> Chemical compound

Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth.

<span class="mw-page-title-main">John C. Martin (businessman)</span>

John Charles Martin was an American billionaire businessman, and the former executive chairman (2016–2018) and CEO (1996–2016) of the American biotechnology company Gilead Sciences. He joined Gilead Sciences in 1990 as vice president for research and development. Gilead is known for developing drugs such as Atripla and commercializing Sovaldi (sofosbuvir) for the treatment of the liver virus hepatitis C. Martin is the recipient of a number of awards, including the Biotechnology Heritage Award (2017).

The Medicines Patent Pool (MPP) is a Unitaid-backed international organisation founded in July 2010, based in Geneva, Switzerland. Its public health driven business model aims to lower the prices of HIV, tuberculosis and hepatitis C medicines and facilitate the development of better-adapted HIV treatments through voluntary licensing and patent pooling. Its goal is to improve access to affordable and appropriate HIV, hepatitis C and tuberculosis medicines in low- and middle-income countries (LMIC). In May 2020, the MPP become an implementing partner of the WHO's Covid-19 Technology Access Pool (C-TAP).

Elbasvir/grazoprevir, sold under the brand name Zepatier, is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir and grazoprevir. It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and treatment-experienced patients.

<span class="mw-page-title-main">Remdesivir</span> Antiviral drug

Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein. During the COVID‑19 pandemic, remdesivir was approved or authorized for emergency use to treat COVID‑19 in numerous countries.

Access to medicines refers to the reasonable ability for people to get needed medicines required to achieve health. Such access is deemed to be part of the right to health as supported by international law since 1946.

Raymond F. Schinazi is an American organic medicinal chemist at Emory University with expertise in antiviral agents, pharmacology, and biotechnology. His research focuses on developing treatments for infections caused by human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), herpes, dengue fever, zika, chikungunya, and other emerging viruses. These treatment options include antiviral agents as well as synthetic, biochemical, pharmacological and molecular genetic approaches, including molecular modeling and gene therapy.

<span class="mw-page-title-main">Pauline Londeix</span> French activist researcher and writer (born 1986)

Pauline Londeix is a French activist researcher and writer, who has been particularly involved in the fight for the access to generic medicines used against HIV and Hepatitis C virus (HCV), in particular through contributing to challenging monopolies and intellectual property barriers in the Global South, but also in high income countries, such as France. In 2008, she was the Vice President of the French HIV/AIDS organisation Act Up-Paris. In 2011, she co-founded Act Up-Basel.

Tomáš Cihlář is a Czech biochemist known for his role in the development of remdesivir. A specialist in virology, Cihlář holds the positions of Senior Director, Biology, and Vice-President at American pharmaceutical company Gilead Sciences. As a student, Cihlář assisted fellow biochemist Antonín Holý in developing Viread, the primary drug used to fight HIV infection.

Priti Krishtel is a lawyer and advocate for patent reform and increased public participation in the patent system. She co-founded the United States-based nonprofit organization the Initiative for Medicines, Access, and Knowledge.

References

  1. 1 2 Waltz, Emily (January 1, 2014). "Sequenom falls after judge invalidates Down's patent" (PDF). Nature Biotechnology. 32 (1): 5. doi:10.1038/nbt0114-5. ISSN   1546-1696. S2CID   28736102.
  2. ↑ Fri; Krishtel, July 23, 2021 01:37pm-Priti; Amin, Tahir (July 23, 2021). "10 Steps The Biden-Harris Administration Should Take To Bring Equity To Our Patent System". Techdirt. Retrieved July 29, 2022.{{cite web}}: CS1 maint: multiple names: authors list (link) CS1 maint: numeric names: authors list (link)
  3. 1 2 3 Te, Nhu. "2019 Unsung Heroes". NonProfit PRO. Retrieved July 29, 2022.
  4. ↑ The Editorial Board (April 16, 2022). "Opinion | Save America's Patent System". The New York Times. ISSN   0362-4331 . Retrieved July 29, 2022.
  5. 1 2 Quigley, Fran (November 17, 2017). "Patent Fighters: Taking on Big Pharma". Health and Human Rights.
  6. ↑ I-MAK. "Donate – I-MAK". www.i-mak.org. Retrieved July 15, 2022.
  7. 1 2 3 "China rejects Gilead hepatitis C drug patent -advocacy group". Reuters. June 19, 2015. Retrieved January 6, 2023.
  8. ↑ Gibney, Michael (January 15, 2015). "Gilead Denied Patent for Hepatitis C drug sofosbuvir in India". Fierce Pharma. Retrieved July 29, 2022.
  9. ↑ Graham, Camilla S. (July 21, 2020). "The Current Status of US and Global Access to Direct-Acting Antiviral Regimens for Hepatitis C Virus Infection". Clinical Liver Disease. 16 (1): 16–19. doi:10.1002/cld.925. ISSN   2046-2484. PMC   7373775 . PMID   32714518.
  10. ↑ Pierson, Brendan (June 19, 2015). "China rejects Gilead hepatitis C drug patent -advocacy group". Reuters. Retrieved January 9, 2022.
  11. 1 2 Sinha, Gunjan (June 23, 2021). "How patent extensions keep some drug costs high". Salon. Retrieved July 29, 2022.
  12. 1 2 3 4 The Editorial Board (April 16, 2022). "Opinion | Save America's Patent System". The New York Times. ISSN   0362-4331 . Retrieved January 6, 2023.
  13. ↑ I-MAK. "Impact – I-MAK". www.i-mak.org. Retrieved July 21, 2022.
  14. ↑ Chandrasekharan, Subhashini; Amin, Tahir; Kim, Joyce; Furrer, Eliane; Matterson, Anna-Carin; Schwalbe, Nina; Nguyen, Aurélia (November 17, 2015). "Intellectual property rights and challenges for development of affordable human papillomavirus, rotavirus and pneumococcal vaccines: Patent landscaping and perspectives of developing country vaccine manufacturers". Vaccine. 33 (46): 6366–6370. doi: 10.1016/j.vaccine.2015.08.063 . ISSN   0264-410X. PMID   26368398.
  15. ↑ "Indian Government Rejects Abbott's Patent Application For Second-Line ARV". Kaiser Health News. January 4, 2011. Retrieved July 29, 2022.
  16. ↑ Grillon, Céline; Krishtel, Priti R; Mellouk, Othoman; Basenko, Anton; Freeman, James; Mendão, Luís; Andrieux-Meyer, Isabelle; Morin, Sébastien (April 2018). "Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low- to high-income settings: making sure no one is left behind". Journal of the International AIDS Society. 21 (Suppl Suppl 2): e25060. doi:10.1002/jia2.25060. PMC   5978639 . PMID   29633580.
  17. ↑ Robbins, Rebecca (January 28, 2023). "How a Drug Company Made $114 Billion by Gaming the U.S. Patent System". The New York Times. ISSN   0362-4331 . Retrieved April 24, 2023.
  18. ↑ "Priti Krishtel, a critic of medical patents, is a MacArthur Fellow". Global Indian Times. Archived from the original on January 6, 2023. Retrieved January 6, 2023.
  19. ↑ Thomas-Smith, Ayeisha. "Weekly Economics Podcast: Vaccine Nationalism". New Economics Foundation. Retrieved July 29, 2022.
  20. ↑ "Racial disparities create obstacles for Covid-19 vaccine rollout". NBC News. Retrieved July 29, 2022.
  21. ↑ Wise, Jacqui (July 3, 2020). "Remdesivir: US purchase of world stocks sparks new "hunger games," warn observers". BMJ. 370: m2661. doi: 10.1136/bmj.m2661 . ISSN   1756-1833. PMID   32620681. S2CID   220303420.
  22. ↑ Krishtel, Priti; Hassan, Fatima (October 22, 2021). "Share vaccine know-how". Science. 374 (6566): 379. Bibcode:2021Sci...374..379K. doi:10.1126/science.abm8724. ISSN   0036-8075. PMID   34672761. S2CID   239455290.
  23. ↑ "Covid Seen as Tipping Point to Lower Drug Prices, Patent Sharing". news.bloomberglaw.com. Retrieved July 29, 2022.
  24. ↑ "Business Daily – Big Pharma: Vaccine Heroes or Profiteers? – BBC Sounds". www.bbc.co.uk. Retrieved July 29, 2022.

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