Improving access to HIV treatment in Ukraine by addressing intellectual property barriers

Improving access to HIV treatment in Ukraine by addressing intellectual property barriers

Project

As of 2016, there were an estimated 224,000 PLHIV in Ukraine, all ages (0.9% of the 15 – 49 year old population) , while only 82860 persons (37%) were receiving ART as of 1 July 2017 . From 1.1 mln persons living with HCV in Ukraine (3% of total population) , an estimated 34,711 PLHIV are coinfected with HCV in Ukraine, while within state funded program only about 4036 patients shall receive DAA-based treatment for MoH’s funding. There exists a significant treatment gap in Ukraine due to high prices on patented HIV, HCV, oncology medicines.
The Ukrainian Intellectual Property Institute is working under rather lax standards on granting patents on pharmaceuticals and TRIPS-flexibilities are almost not implemented in Ukraine. Although, Ukraine has a potent generic industry, competition on overpriced medicines is prohibited by patents. Thus, reform of the patent law to implement TRIPS-flexibilities have potential for impact on medicines pricing in Ukraine.
Ukraine also possesses a Network of PLWHA with patent law experts to support the intervention, and a political openness to achieve its goals. For the past 3 years the Network had filed more than 3 patent oppositions in relation to HIV and HCV medicines and initiated the development of legislative proposals aimed at introduction of TRIPS-flexibilities and mitigation of existing TRIPS-plus provisions in Ukraine.
The end goal of the program is to make a strong case for patent law reform in Ukraine and conduct active discussions with the government on developed legislative proposals to implement patent law reform in relation to medicines in Ukraine. The Network and Patients of Ukraine in collaboration with the National IP Research Institute will promote the initiative of patent law reform to improve access to medicines in Ukraine, by building capacity of various patients' organizations, conducting dialogue with decision makers, building evidence basis, utilizing PR instruments.

Project details

Time frame
31 March 2018 - 30 March 2021
Budget
€ 250,000
Active in
Ukraine

Objectives

End goal of the program is to build a strong case for patent law reform in Ukraine and conduct active discussions with the government on developed legislative proposals to implement patent law reform in relation to medicines in Ukraine. Outcome A: Conducting a short study on prices, patents and state of access to HIV, HCV, TB, oncology medicines that are most of all patented in Ukraine and are overpriced. The study will be a basis for defining priorities of common patients organizations position on patents and A2M. Outcome B: Building capacity and common position of patients organizations on patent-related issues from access perspective. A coalition of patient organizations is already created under umbrella patient organization CF 'Patients of Ukraine', who will be Network's main partner in patent law reform advocacy. Trainings/round tables shall be conducted in building common vision and creating common advocacy messages from the coalition of patient organizations. Outcome C: Conducting an evergreening and/or impact assessment study to build evidence for the patent law reform proposal. The Network is conducting within the UNITAID and OSF funded projects a first ever evergreening study in Ukraine. Additional resources are needed to expand the number of patents to make the study statistically more powerful. Outcome D: Finalization of development of legislative proposal on patent law reform and discussion with government officials of developed proposal. Patent law reform will institutionalize at the law level anti-evergreening provisions reducing the amount of patents in future and create opportunities for increased generic competition in Ukrainian pharmaceutical market; patent oppositions mechanism that could be easily used by local generic pharmaceutical industry; parallel importation of medicines that may be used by local distributors.

Community groups

As new HIV medicines are widely patented by pharmaceutical companies using various 'evergreening' practices, the patent law reform will help in the long run to reduce the quantity of secondary patents on antiretroviral medicines. This will create conditions for wider competition for the ARVs and will induce price reductions for the ARVs in Ukraine in the long term perspective. It is planned that the HIV treatment program shall have on treatment up to 195 000 patients by 2020 (with up to 23000 patients funded by the Global Fund). Decrease in prices for antiretrovirals will improve the sustainability of treatment program and create opportunities for transition to 100% funding by state.

Background

Ukraine has a growing domestic drug industry, presence on the market of major Indian generic manufacturers and unaffordable ARV and DAA prices with significant treatment gap of HIV and HCV epidemics.
Ukraine also possesses a PLHIV network with a patent law expert to support the intervention, and a political openness to achieve its goals. For the past 3 years the Network had filed more than 3 patent oppositions in relation to HIV (LPV/r, TAF) and HCV medicines (SOF) and initiated within the Ministry of Economy and Parliamentary Healthcare Committee the development of legislative proposals aimed at introduction of TRIPS-flexibilities and mitigation of existing TRIPS-plus provisions in Ukraine. The Network has also been monitoring DAA patents, procurements, engaging in legal advocacy and working on treatment and IP literacy/demand generation activities in Ukraine, and is well-positioned to take this work forward.

The volume of international aid in the country is high and, accordingly, the influence exerted on the country is high. Based on the experience of introducing patent law reforms and issuance of CL by other countries, we can expect international and internal pressure. Given the volume of aid (EU & USAID), the level of influence and the economic crisis - the risks are quite high.
However, the position on the promotion of patent law reform by civil activists can be assessed as extremely beneficial: in-country level - strong influence by civil society and number of advocacy opportunities, at the international level- Ukraine is popular - attracts attention, well known and supported.

Goals

Everyone living with HIV worldwide receives treatment
100%
Contributed within this project

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