Access to treatment for people living with HIV in middle income countries

The Network of PLWH is actively advocating for the expansion of access to treatment, including within the framework of the project “Access to treatment for people living with HIV in middle income countries” funded by UNITAID under the World Health Organization (WHO).

The 3-year project strategy was designed to increase the access of people living with HIV to treatment by reducing the cost of ARV drugs. Lowering prices may become possible as a result of increased competition in manufacturing and import of ARV drugs through the elimination of patent barriers. It is planned to achieve this by advocating for patent reform, in particular, introducing provisions of international agreements aimed at facilitating access to medicines (so-called TRIPS flexibility mechanisms) in the Ukrainian legislation. The project envisages advocacy work on preventing the adoption of legislative changes that may restrict the access of patients to medicinal products, as well as hamper filing of claims for invalidation of ARV patents if they do not comply with the requirements of the legislation.

• Enhancing public awareness of the need for patent reform and the elimination of unfair patent monopolies.
• Eliminating the patent monopoly on medicines where abacavir is the active substance (estimated savings in the immediate procurement of the Network of PLWH within the Global Fund program will be about USD 271,284.00). These savings will suffice to purchase ARVs for more than 2,600 new patients in Ukraine.

General information about the project

Project: Access to treatment for people living with HIV in middle income countries.

Donor: UNITAID (through ITPC Global).

Participating countries: Ukraine, Brazil, Argentina, Thailand.

Budget: USD 6 000 000 (for all participating countries).

Period: 31.10.2014 – 31.10.2017.

A patent for a medicinal product authorizes the patent holder to have a monopoly over its import and manufacturing as a reward for the invention of a new medicinal product having obvious advantages over the already existing analogues.

In practice, however, weak requirements to patent applications established by patent offices of some countries lead to the issuance of patents for medicinal products which often are not truly new, inventive and present no significant advantages over analogues for a long time already. The patent holders’ monopoly rights allow them to prohibit the import and manufacture of a patented medicinal product by other manufacturers and to set the price which the patent owner considers necessary. Because of this, certain medications are overpriced several times and, accordingly, the number of patients who could be treated is several times lower than it would be if a patent office considered a patent application more stringently and declined it.

The main objective of the project is to advocate for the patent law reform in the participating countries in order to prevent patenting of medicines that are not really new and have no significant advantages over existing analogues, as well as establishment of legal mechanisms that prevent the patent holder from abusing their patent rights. It is expected that the implementation of these tasks will save significant funds allocated for the purchase of ARV medications and thus significantly increase the number of HIV-positive people receiving ARV therapy.

Project activities

1. Patent Reform Advocacy: inclusion of provisions protecting public health in the patent laws of participating countries.
2. Opposition to legislative initiatives that can pose public health considerations (so-called TRIPS+).
3. Patent opposition: filing lawsuits to challenge patents for ARV drugs that do not meet the requirements of the law (in particular, the requirements of novelty and inventiveness level).
4. Improvement of compulsory licensing legislation (i.e. the use of a patent without the consent of the patent holder and payment of remuneration for such use) − a legal instrument applied in the international practice if the patent owner abuses patent rights.

The main project indicators

1. Annual savings of about USD 5 million for pharmaceuticals procurement in Ukraine and Thailand in total (10 million in Argentina and Brazil).
2. Challenging at least two patents for ARV medications in each participating country.
3. At least 50% reduction in prices for at least 2 ARV medications in each participating country.

To date, the main efforts of the project team are focused on the advocacy of the draft amendments to the Law of Ukraine “On the Protection of Rights to Inventions and Utility Models” developed on the initiative of the Network, as well as to counteracting legislative initiatives that could have adverse impact on access to ARVs. Within the framework of the project, a lawsuit was prepared and filed on the invalidation of an ARV patent on the grounds of its non-compliance with the criteria of novelty and inventive level, several more similar lawsuits are in the process of preparation.