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Medicines Patent Pool

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The Medicines Patent Pool (MPP) is a Unitaid-backed international organisation founded in July 2010,[1] 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).[2]

Peer-reviewed economics research find that the MPP substantially increased generic drug supplies, especially in countries with stronger patent protection; positive spillover effect to upstream innovation is found in clinical trials and drug product approvals in MPP-related drugs.[3] A related study found that there is an immediate and large increase in licensing of a life-saving drug in low- and middle-income countries when the patent is included in the MPP.[4] An article in The Conversation has summarized issues in the patent system, relevance to LMIC, and the role of the MPP.[5]

Creation

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The United Nations-backed Medicines Patent Pool Foundation was established as an independent legal public health entity in July 2010 with the support of Unitaid and has been fully operational since November 2010.[6][7]

The MPP was established in response to the global HIV/AIDS epidemic, which reached a crisis in LMIC countries that were unable to access essential patented medicines.[6][8]: 291–324  In 2006, Médecins Sans Frontières (MSF) presented the idea of patent pool to the French Foreign Ministry and UNITAID.[9] The MSF proposal was for an entity that would be dependent on patent holders—"particularly private pharmaceutical companies"—voluntarily agreeing to allow LMIC countries access to their licensed essential medicines.[8]: 291  UNITAID was first developed under the impetus of France in 2006, as a "new drug purchasing facility for HIV, TB and malaria" medications.[9] UNITAID provided "innovative solutions" to "overcome access and innovation barriers for HIV medicines".[9]

It is based on the idea that patents are intended to reward innovation, and that unless licensed, a patent can also prevent the production or sale of affordable, quality-assured generic medicines and the development of novel formulations.[8]: 291–324  The Medicines Patent Pool negotiates with patent holders for licences on HIV, hepatitis C and tuberculosis medicines. These licences permit lower-cost manufacturers to distribute patented medicines in developing countries. Licences also provide the freedom to develop new treatments better suited for resource-limited settings, such as paediatric formulations and fixed-dose combinations. Competition among many manufacturers should bring prices down supporting treatment scale-up.[citation needed]

Financing

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The Medicines Patent Pool was founded and is funded by Unitaid, a global health initiative that is working with partners to end HIV/AIDS, malaria, tuberculosis and hepatitis C and works to allow more affordable generic medicines to enter the marketplace in low- and middle-income countries. UNITAID provided the initial $US 4 million to set up MPP in 2010.[1] In its first grant phase 2010–2015, the MPP worked exclusively in the HIV field and in December 2014, Unitaid approved another funding package for MPP to continue its HIV work through 2020. In November 2015, the MPP mandate was expanded to hepatitis C and tuberculosis treatment. The Medicines Patent Pool was the first and is now the only independent patent pool that aims to tackle the issue of access to HIV/AIDS, hepatitis C and tuberculosis drugs in low- and middle-income countries.[10]

Structure

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The MPP has two governing bodies: a Governance board (i.e.Executive Board) composed of 9 members and an Expert Advisory Group comprising 12 members, it also works with ad hoc experts.[11]

The current Chair of the Governance Board is World Health Organization (WHO)’s former Assistant Director-General for Health Systems and Innovation Marie-Paule Kieny,[12] who succeeded Sigrun Møgedal, chair since March 2016 and Charles Clift, the MPP's founding chairman. Past executive directors includes Charles Gore (2018), Greg Perry (2013–2017), Ellen 't Hoen (2010–2012).[citation needed]

Activities

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The Medicines Patent Pool negotiates public-health driven licences with patent holders, and sub-licenses to generic manufacturers to encourage the sale of lower-cost generic versions of medicines in over a hundred developing countries.[citation needed]

In October 2012, the MPP, Gilead Sciences and the UN National Institutes of Health/University of Illinois were honoured by the Licensing Executives Society (United States and Canada) (LES) for licence agreements that expand access to affordable HIV medicines in developing countries. The LES's annual "Deals of Distinction" Awards are presented to notable intellectual property agreements in five industry sectors and the three parties were recognised for precedence-setting licensing agreements dedicated to improving public health under the Industry-University-Government Interface category.[13]

By 2013, MPP in collaboration with ViiV Healthcare granted 14 voluntary licences generics companies for low-cost versions of abacavir used to treat children living with HIV.[6] As of 2018, the Medicines Patent Pool holds licences for 13 HIV antiretrovirals, an HIV technology platform, 2 hepatitis C direct-acting antivirals and 1 investigational treatment for tuberculosis from patent holders AbbVie,[14] Bristol-Myers Squibb,[15] Gilead Sciences,[16][17] MSD,[18] ViiV Healthcare,[19][20] Johns Hopkins University,[21] the University of Liverpool, the US National Institutes of Health[22] and Pharco Pharmaceuticals.[23] The MPP also worked with Janssen[24] and Boehringer Ingelheim[25] to extend their non-assert policies for paediatric darunavir formulations and nevirapine, ensuring that the companies will not assert their patent rights in many more developing countries. The organisation signed an agreement with F. Hoffmann-La Roche[26] to increase access to valganciclovir, an important treatment for an HIV opportunistic infection.

In 2018, the foundation announced a new five-year strategy[27] to improve access to medicines in low- and middle-income countries, which supports international public health goals for HIV, tuberculosis and hepatitis C.

In 2021 deals have been achieved with Merck and Pfizer to allow the manufacture Molnupiravir and Paxlovid without paying royalties in poorer countries.[28][29]

See also

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References

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  1. ^ a b "Patent Pool Implementation Plan" (PDF), UNITAID, 15 December 2009, archived from the original (PDF) on 23 April 2010, retrieved 3 May 2021
  2. ^ "COVID-19 technology access pool". World Health Organization. 30 June 2020. Retrieved 3 May 2021.
  3. ^ Wang, Lucy Xiaolu (14 August 2022). "Global Drug Diffusion and Innovation with the Medicines Patent Pool". Journal of Health Economics. 85: 102671. doi:10.1016/j.jhealeco.2022.102671. ISSN 0167-6296. PMID 36030748. S2CID 251576186.
  4. ^ Galasso, Alberto; Schankerman, Mark (2022). "Licensing Life-Saving Drugs for Developing Countries: Evidence from the Medicines Patent Pool". The Review of Economics and Statistics: 1–40. doi:10.1162/rest_a_01253. ISSN 0034-6535.
  5. ^ Wang, Lucy Xiaolu (5 December 2022). "Pharma's expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation". The Conversation. Retrieved 10 December 2022.
  6. ^ a b c "ViiV Healthcare announces a voluntary licence agreement with the Medicines Patent Pool to increase access to HIV medicines for children: Agreement brings the number of voluntary licenses granted by ViiV Healthcare to 14" (Press release). London, UK. 27 February 2013. Archived from the original on 18 June 2013. Retrieved 3 May 2021.
  7. ^ "About". Medicines Patent Pool. Retrieved 3 May 2021.
  8. ^ a b c Cox, Krista L. (24 August 2017). "The Medicines Patent Pool: Promoting Access and Innovation for Life-Saving Medicines Through Voluntary Licenses". Hastings Science and Technology Law Journal. 4 (2). LawArXiv: 35. Retrieved 3 May 2021.
  9. ^ a b c Childs, Michelle (19 January 2010). "Towards a Patent Pool for HIV Medicines: The Background". The Open AIDS Journal. 4: 33–36. doi:10.2174/1874613601004020033. ISSN 1874-6136. PMC 2817875. PMID 20148090.
  10. ^ "Medicines Patent Pool Expands To Include Hepatitis C, Tuberculosis". IP Watch. 9 November 2015. Retrieved 9 October 2017.
  11. ^ "Governance - Medicines Patent Pool". medicinespatentpool.org/staffing-and-governance/.
  12. ^ "Medicines Patent Pool Nets WHO's Kieny As New Chair". IP Watch. 3 July 2017. Retrieved 9 October 2017.
  13. ^ "Five Landmark IP Deals Receive Licensing Executives Society's Prestigious 2012 Deals of Distinction™ Awards". lesusacanada.org. Archived from the original on 28 June 2013.
  14. ^ "AbbVie adds children's AIDS drugs to shared patent pool". Reuters. December 2014.
  15. ^ Kalil, Tom; Steffen, Robynn (12 December 2013). "Bristol-Myers Squibb and Medicines Patent Pool Increase Access to Critical HIV Drug". whitehouse.gov. Retrieved 16 April 2015 – via National Archives.
  16. ^ HIRSCHLER, BEN (12 July 2011). "Gilead kickstarts patent pool for AIDS drugs". Reuters. Retrieved 16 April 2015.
  17. ^ "UNAIDS". unaids.org.
  18. ^ William New (24 February 2015). "Medicines Patent Pool Nails Down Another Key Paediatric Drug". Intellectual Property Watch.
  19. ^ "ViiV Healthcare announces a voluntary licence agreement with the Medicines Patent Pool to increase access to HIV medicines for children | ViiV Healthcare". Archived from the original on 18 June 2013. Retrieved 27 June 2013.
  20. ^ "GSK's ViiV unit adds new HIV drug to AIDS patent pool". Reuters. April 2014.
  21. ^ "The Medicines Patent Pool Announces First Licence for Tuberculosis Treatment". Cision. PR Newswire. 24 January 2017. Retrieved 9 October 2017.
  22. ^ "Press room". MSF USA. Archived from the original on 24 October 2013.
  23. ^ "The Medicines Patent Pool and Pharco Pharmaceuticals Sign Licence for Promising Hepatitis C Drug Candidate Ravidasvir". Cision. PR newswire. 21 April 2017. Retrieved 9 October 2017.
  24. ^ "The Medicines Patent Pool on Janssen's Extension of its Access Policy for Paediatric Medicine Darunavir". Medicines Patent Pool. Archived from the original on 9 October 2017. Retrieved 9 October 2017.
  25. ^ "Boehringer Ingelheim increases access to the medication for the treatment of HIV/Aids". Boehringer Ingelheim. Retrieved 9 October 2017.
  26. ^ "Roche-MPP agreement" (PDF). Roche. Archived from the original (PDF) on 7 August 2018. Retrieved 7 August 2018.
  27. ^ "The Medicines Patent Pool presents new five-year strategy". PR Newswire (Press release). Retrieved 5 August 2018.
  28. ^ "The Medicines Patent Pool (MPP) and Merck Enter Into License Agreement for Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, to Increase Broad Access in Low- and Middle-Income Countries". Merck.com. Retrieved 17 November 2021.
  29. ^ "Covid-19: Pfizer to allow developing nations to make its treatment pill". BBC News. 16 November 2021. Retrieved 17 November 2021.
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