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УкраїнськаРусский

PROJECT “IMPROVING ACCESSIBILITY OF HCV TREATMENT IN UKRAINE”

The Network of PLWH is actively advocating for expanding access to treatment for Hepatitis C in Ukraine. In particular, this is being carried out within the framework of the project “Improving the Availability of Hepatitis C Treatment in Ukraine”, which is being implemented with the support of the OSI Foundation (Open Society Institute).

The goal of the project is to increase access to direct-acting antivirals (DAAs) for the treatment of Hepatitis C by reducing their prices. Lowering prices may become possible as a result of preventing a monopoly on production and import of this category of drugs into Ukraine. In order to prevent the monopoly, it is necessary to ensure the conditions which will preclude issuance of patents − documents authorizing their holders to have a monopoly right to manufacture the drug and import it into Ukraine − for direct acting antivirals (DAAs) for Hepatitis C. This is expected to be achieved by filing objections to the Patent Office against the issuance of patents, as well as filing lawsuits to invalidate already issued patents for direct acting antivirals (DAA) for the treatment of Hepatitis C.

Interim results of the project

General information about the project

Project: Improving access to Hepatitis C treatment in Ukraine

Donor: OSI

Budget: UAH 179 208,00 (12.01.2015 – 01.12.2015), USD 24996 (01.12.2015 – 01.01.2017)

Period: 12.01.2015 – 01.01.2017

A patent for a medicinal product gives the patent holder a monopoly right to import and manufacture the medication. The patent holder’s exclusive rights enable them to prohibit the import and manufacture of a patented medicinal product by other manufacturers and thus establish the prices they consider necessary.

To date, there is an active discussion worldwide about the legality and ethical feasibility of patenting direct-acting antivirals (DAAs) for the treatment of Hepatitis C. This category of medicines has a number of advantages over the pegylated interferons traditionally used in Ukraine to treat Hepatitis C, in particular, much milder side effects, greater efficacy (including in case of HIV/HCV coinfection), shorter treatment period, etc. Patient and international non-governmental organizations have repeatedly expressed their concern about the possibility of patenting direct-acting antivirals (DAAs) for the treatment of Hepatitis C due to the fact that the chemical compounds used in their manufacture are already known in the pharmaceutical industry, as well as highlighted the risk of the monopoly patent rights abuse by the holders. The Network of PLWH calls on the Ukrainian Patent Office to be very rigorous in considering patent applications for direct-acting antivirals (DAAs) for the treatment of Hepatitis C. After all, the patent issue and granting appropriate monopoly rights to the patent holder have a significant impact on the medication price and, accordingly, its accessibility.

Within the framework of this project, the Network of PLWH submits to the patent office objections with the relevant scientific and legal arguments against the granting of patents related to direct-acting antivirals (DAAs) for the treatment of Hepatitis C, and, if necessary, challenges already issued patents in the court.

Project activities

  1. Monitoring of applications for patents and already issued patents related to direct-acting antivirals (DAAs) for the treatment of Hepatitis C in Ukraine.
  2. Submission of objections to the Patent Office against patents for direct-acting antivirals (DAAs) for the treatment of Hepatitis C, and, if necessary, filing lawsuits on the invalidation of already issued patents.
  3. Dialogue with representatives of generic manufacturers on the prospects for the production import of direct-acting antivirals (DAAs) for the treatment of Hepatitis C in Ukraine.
  4. Ancillary activities are aimed at expanding access for people living with Hepatitis C to direct-acting antivirals (DAAs) for the treatment of Hepatitis C in Ukraine.

To date, the key efforts of the project team are focused on discovering patent applications/ patents that could establish a patent monopoly on direct-acting antivirals (DAAs) for the treatment of Hepatitis C in Ukraine and the filing of objections/claims against them.