Challenging intellectual properties of HIV treatment in Ukraine

Challenging intellectual properties of HIV treatment in Ukraine

Project

There exists a significant HIV and Hepatitis C treatment gap in Ukraine due to high prices on patented medicines. 100% Life, the national network of people living with HIV in Ukraine, realized that the only feasible solution to increase access to affordable medicine is to advocate for patent law reform and procurement of generics.

As a result of their advocacy, Ukraine has switched to generic versions of several medicines with subsequent price reductions. The number of people living with HIV accessing treatment increased from 60,000 to 130,000.

Project details

Time frame
01 April 2018 - 30 September 2022
Budget
€ 250,000
Active in
Ukraine

Objectives

End goal of the program was to build a strong case for patent law reform in Ukraine. 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 and price reductions for ARVs in Ukraine.

Strategies to achieve this goal were:
- To build evidence by conducting a study on prices, patents and state of access to HIV and Hepatits C medicines, and on a first ever evergreening study in Ukraine
- To build capacity of patients organisations. A coalition was already created to partner with 100% Life
- Development of a legislative proposal on patent law reform for discussion with government officials.

Community groups

People living with HIV in Ukraine

Background

An estimated 224,000 people in Ukraine were living with HIV (2016), of which only 37% received ART (2017). Out of 1.1 million people living with Hepatitis C, an estimated 34,711 people are co-infected with HIV. Within state-funded programmes only 4036 of them received Hepatitis C treatment.

Ukraine has a middle income status. As a result, the country is often excluded from receiving essential licenses for key medicines and the Ukrainian health budget is restricted. The majority of the pharmaceuticals procured by the government were branded, and thus more expensive compared to generics. The three most procured HIV medicines were supplied by originator companies. Price reduction for ARVs will improve the sustainability of treatment programmes and create opportunities for transition to 100% funding by the government.
 

Results: reformed patent law and improved access to medication

Reformed patent law
As a result of the efforts, patent law reform succeeded. The Ukrainian parliament successfully voted for the Law No. 2259 in the summer of 2020. This law is important since it prevents evergreening practices, and improves access to affordable medicines. In particular, it enables the Ukrainian patent office to reject applications for new modifications of known medicines if they do not contribute to enhancing efficacy. Currently, 100% Life advocates for adoption of several by-laws that would regulate details and procedural aspects of flexibilities set forth by Law No. 2259.

Improved access to affordable HIV medication
As a result of 100% Life’s advocacy between 2016-2020, Ukraine achieved significant price reductions, for example:
- raltegravir from 350 to 165 USD per pack;
- darunavir from 450 to 156 USD per pack;
- lopinavir/ritonavir from 60,80 to about 30 USD per pack.

Due to generic competition and price reductions, the number of people living with HIV receiving ARVs in Ukraine increased from 60.000 to 130.000. Advocacy for above price reductions was done in co-funding with Aidsfonds, the Global Fund and ITPC Global/UNITAID.

Improved access to affordable Hepatitis C treatment
In 2015 and 2016, 100% Life had submitted 3 patent oppositions in order to improve access to affordable Hepatitis C treatment, based on sofosbuvir. As a result, generic versions of Hepatitis C became available in Ukraine in 2017-2018.

Because of these generics, 50,000 people have access to Hepatitis C medication, compared to 5000 patients annually before 2017. Price reductions are:
- sofosbuvir from 1350 to 60 USD per treatment course;
- sofosbuvir/ledipasvir from 900 to 85 USD per treatment course;
- sofosbuvir/velpatasvir from 900 to about 250 USD per treatment course.

This intervention benefited also patients who were not covered by the state programme as prices in pharmacies reduced due to 100% Life’s intervention as well. Advocacy for above Hepatitis C medicines was done in co-funding with Aidsfonds and the Open Society Foundation.

 

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