33. Inform all countries in the paediatric license group on the status of paediatric ARV patents.
March 2022 (also for 2017 HIV treatment)
As of March 2022, MPP licensees for DTG are continuing their development work for the fixed dose combination (FDC) of paediatric ABC/3TC/DTG (ALD – which has been prioritized by PADO and GAP‑f), with multiple manufacturers planning to initiate their bioequivalence studies (BE) upon commercial availability of ViiV Healthcare’s product as reference listed drug (RLD).
In an effort to leave no child behind, and as part of co-chairing the pDTG Task Team of GAP-f’s Product Access and Treatment Delivery Working Group, MPP informed a variety of government, civil society and other contacts in 100 countries outside those receiving the bulk of international support regarding their opportunity to access and roll out generic DTG 10 mg scored dispersible tablets for children living with HIV four weeks and older and weighing 3-20 kg. The information package summarized WHO normative guidance, generic supply information (sources, pricing, approvals), and a large variety of implementation material.
By the end of September 2021, MPP-licensed paediatric DTG 10 mg scored dispersible tablets have been supplied to 29 countries (Angola, Benin, Botswana, Cambodia, Cameroon, Congo, Côte d'Ivoire, Dominican Republic, DRC, Eswatini, Ethiopia, Gambia, Guyana, Haiti, India, Kenya, Lesotho, Liberia, Malawi, Mali, Mozambique, Namibia, Nigeria, Papua New Guinea, South Sudan, Uganda, Venezuela, Zambia, Zimbabwe), and regulatory approval has happened in 4 countries (Congo, Ghana, India, Zimbabwe), while it is pending in an additional 24 countries (Benin, Botswana, Burkina Faso, Cameroon, Chad, Côte d’Ivoire, DRC, Ethiopia, Kenya, Malawi, Mali, Mozambique, Namibia, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Thailand, Togo, Uganda, Uzbekistan, Viet Nam, Zambia)
October 2021 (also for 2017 HIV treatment)
As part of co-chairing the pDTG Task Team of GAP-f’s Product Access and Treatment Delivery Working Group, MPP is leading ongoing coordination to inform the countries able to access generic DTG 10 mg scored dispersible tablets as per the MPP licence territory here (including those able to access the Unitaid/CHAI negotiated price too). Current tasks include the mapping of existing partner support to countries and preparation for actionable information to be sent to Ministries of Health, implementers, and advocates in identified non-supported countries.
The 135 countries able to access generic DTG 10 mg scored dispersible tablets through the MPP licence territory can be visualized on the map below in dark and light green (and here). So far, as of June 2021, 18 countries (Angola, Benin, Cameroon, Congo, Côte d'Ivoire, Dominican Republic, DRC, Eswatini, Gambia, Guyana, Haiti, Kenya, Malawi, Namibia, Nigeria, Uganda, Zambia, Zimbabwe) have been supplied with paediatric DTG 10 mg scored dispersible tablets through MPP-licensed generic manufacturers, and regulatory approval has happened in 3 countries (Congo, Ghana, India), while it is pending in an additional 18 countries (Botswana, Burkina Faso, Chad, DRC, Ethiopia, Kenya, Malawi, Mali, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Viet Nam, Zambia, Zimbabwe).
While the COVID-19 pandemic has attracted a lot of MPP’s interest and efforts, this has not impacted our resolve to prioritize paediatrics, as shown by our continued close engagement with GAP-f’s Steering Group (and our new role as co-chair of its pDTG Task Team), as well as with generics manufacturers around identified PADO priorities.
June 2021 (also for 2017 HIV treatment)
As outlined in a MPP statement published on 5 May 2021, MPP-licensee Viatris (through its subsidiary Mylan) had already received orders for DTG 10 mg scored dispersible tablets from more than ten countries, and the paediatric HIV medicine was starting to be delivered in Benin, Côte d’Ivoire, the Democratic Republic of the Congo, Haiti, Kenya, Malawi, Nigeria, Uganda, Zambia, Zimbabwe, as well as other sub-Saharan African countries through pooled procurement. Both MPP-licensees Viatris and MacLeods have received U.S. FDA tentative approval for this product. The statement is available here.
Later in May, and following their inclusion in a licence for DTG use in adults, two countries were added to the royalty-free MPP-ViiV Healthcare licence for DTG for paediatric use: Belarus and Kazakhstan. This information has been updated on the MPP website here. Accordingly, and complementing ongoing efforts to support rapid roll-out of DTG 10 mg scored dispersible tablets to priority countries, MPP has started coordinating with the GAP-f Product Access and Treatment Delivery Working Group to ensure that all 135 countries able to access this product are informed of this opportunity, thereby leaving no one behind. The territory where MPP licensees can supply this product can be explored through MPP’s online interactive access to medicines map here.
April 2021 (also for 2017 HIV treatment)
Two MPP licensees have now received FDA Tentative Approval for DTG 10 mg scored dispersible, allowing them to supply more than 121 countries as shown on MPP’s access to medicines interactive map at https://medicinespatentpool.org/progress-achievements/access-to-medicines-tracker#Interactive-Map
MPP is coordinating with GAP-f (in particular its Product Access and Treatment Delivery Working Group), offering its support to ensure that all countries able to access the new generic paediatric DTG 10 mg scored dispersible formulations are informed of this opportunity, thereby leaving no one behind.
In its continued efforts to inform stakeholders on the geographical scope of licences covering paediatric HIV medicines, and their actual access status – registered and/or supplied – in those countries, MPP has launched a new interactive map that allows visualizing information for all its licensed products, including innovative paediatric DTG- and LPV/r-based fixed-dose formulations. On this map, MPP licence coverage is displayed not only for countries specifically listed in the corresponding licence, but also for countries where supply by MPP licensees may be permitted under some circumstances (e.g., if no patent is being infringed in that country), allowing a broader, more accurate perspective on where access to generic products is possible. For the products that are already on the market, information on in-country registration and supply is also available. The map is available on the MPP website at https://medicinespatentpool.org.
MPP has started developing a summary overview document presenting the patent and licensing status, as well as information on optimal formulations and quality-approved sources of products recommended and prioritized in WHO HIV guidelines and PADO 4. MPP will be seeking input from GAP-f partners shortly as MPP assembles a pilot version to be transformed into a regularly updated webpage. MPP believes that summarizing this content into a single source and widely disseminating it will help countries, procurement agencies, HIV service delivery organizations and other stakeholders navigate access to affordable, quality-approved versions of recommended and priority paediatric ARVs more easily.
On 1 December 2019, MPP announced that generic manufacturer Cipla had become a sublicensee of the MPP/AbbVie licence for paediatric lopinavir/ritonavir (LPV/r). Through this agreement, 21 additional countries, where LPV/r patents are in place (or pending) and representing approximately 74,000 children living with HIV under 5 years of age, will be able to access paediatric LPV/r pellets. The sublicence will also enable access to Quadrimune, Cipla’s incoming 4-in-1 paediatric fixed dose combination of LPV/r with abacavir (ABC) and lamivudine (3TC), currently under review by the US FDA for use in children between 3 and 25 kg. Beyond concluding this agreement, MPP is coordinating with key stakeholders to ensure that countries and procurement agencies are informed of the recently expanded access to these products.
The 21 additional countries concerned include 16 countries with a patent in place (Armenia, Azerbaijan, Georgia, Guatemala, Indonesia, Kyrgyzstan, Malaysia, Moldova, Panama, Peru, Philippines, South Africa, Sri Lanka, Tajikistan, Turkmenistan, Vietnam) and 5 countries with an ongoing patent application or appeal but without a granted patent yet (Dominican Republic, El Salvador, Honduras, Nicaragua, Thailand).
In addition to targeted information dissemination efforts, MPP has also updated its webpage dedicated to paediatrics (https://medicinespatentpool.org/what-we-do/our-work/paediatrics), where features relevant to paediatric drug formulation development, manufacturing, distribution and overall access are highlighted for all MPP licences in the areas of HIV, hepatitis C and TB.
Individual Commitment: The Medicines Patent Pool (MPP) commits to facilitating access to the best available medicines for children. Specifically, the MPP will continue to work with patent holders to in-license paediatric drugs as prioritized by the WHO/PADO, and to sublicense to generic manufacturers to ensure that appropriate formulations are rapidly developed, registered and made available in as many developing countries as possible.
Individual commitment: MPP reports having increased the emphasis on recommended and priority paediatric drug formulations listed in WHO 2019 HIV guidelines and PADO 4 in the regular conversations with MPP licensees, while exploring with patent holders practical ways to further expand access to optimal formulations for paediatric populations. As part of this, MPP's dolutegravir (DTG) paediatric licence now allows for MPP licensees to manufacture any pharmaceutical composition that has been approved by the U.S. FDA and/or recommended by WHO for use in paediatric patients (HIV patients of less than 18 years old).
In March 2020, the Medicines Patent Pool (MPP) received a communication from AbbVie indicating its decision to waive any restriction on MPP licensees that would prevent them from supplying lopinavir/ritonavir (LPV/r) anywhere in the world for any purpose, effective immediately. The communication also indicated that AbbVie will no longer be enforcing patents relating to adult and paediatric LPV/r anywhere in the world. This decision has been reflected on MedsPaL.