- 2020 will be remembered for COVID-19. The scale of the pandemic highlights the urgent need to ensure equitable access to drugs and vaccines, and at the same time underlines how the current system is not fit for purpose.
- In the context of COVID-19, our partner in Ukraine, 100% LIFE, has published two new research reports, highlighting how the abuse of the patent system directly reduces access to medicines.
- The purpose is inform and support the advocacy work of treatment activists in Ukraine and the region, as well as across the Make Medicines Affordable partnership, and for treatment activists everywhere – to help increase access to life-saving treatments.
Evergreening patents in Ukraine
Researchers analyzed 132 patents granted on the most important life-saving medicines in Ukraine, including on drugs used to treat HIV, TB, hepatitis, cancers and rheumatoid arthritis.
Methods were developed to determine which patents are examples of evergreening, a tactic employed by pharmaceutical companies to keep patents fresh, well beyond the original 20 year patent term.
Two key documents were used to develop the evaluation criteria: Guidelines for the Examination of Pharmaceutical Patents, developed with the support of WHO, UNCTAD and ICTSD (2007), and Guidelines for the Examination of Patent Applications Relating to Drugs, developed with the support of UNDP (2006).
60 of the 132 patents examined were found to be example of evergreening, which equates to just over 45%.
Almost half of all patents examined shouldn’t have been applied for – this is what abuse of the patent system looks like.
While evergreening patents affect almost all disease areas, the researchers found that HIV and cancer medicines are most affected, and additionally, unmerited patents are overwhelmingly applied for by multinational companies, based outside of Ukraine.
The report details: the research methods; findings on each evergreening patent; groups the type of patent abuse; and provides a summary of the findings. The report is available in English, Russian and Ukrainian.
The impact of TRIPS+ provisions impact on access to medicines in Ukraine
This study focused on data exclusivity, patent linkage, and supplementary protection certificates (SPC).
The research establishes that the link between the patent status of the medicine and its registration (known as ‘patent linkage’), delays the entry of affordable generics to the Ukrainian market. Calculations show that the average delay is just over one year, which annually results in significant overpayments on medicine procurements.
The research found that one third of the medicines registered by the fast-track procedure in Ukraine in recent years have data exclusivity protection in addition to the patent monopoly. This ‘double monopolization’ poses a serious delay to the entry of more affordable generic versions.
The most harmful TRIPS+ provision is the supplementary protection certificate. The research contains five case studies of the devastating impact of SPCs on drug prices and access to medicines.
Ukraine was overcharged by $2.5 million for essential cancer drugs in one year.
For example, due to the gaps in SPC legislation in 2018 Ukraine overpaid more than $2.5 million (USD) on the procurement of two anti-cancer medicines – rituximab and capecitabine.
“The data for 2018 demonstrates that four most expensive medicines (by the volume of sales) procured by the state are protected by evergreening patents. Furthermore, many essential medicines were granted additional monopolization by means of dubious supplementary protection certificates. Therefore, tens of millions of dollars are overpaid each year which is unnecessary luxury for a lower middle income country such as Ukraine. To stop this we had been advocating patent law reform and hope that since it has entered into force in August not a single evergreening patent or unmerited SPC has or will be granted in Ukraine,” says Sergii Dmytriiev, 100% LIFE`s Policy and Advocacy Director.
The report is available in Ukrainian. It will be available in English early 2021.
Additional resources from 100% LIFE, Ukraine (in English):
- Why Ukraine needs a patent reform for medicinal products?
- Report on the legal analysis of TRIPS-plus provisions in Ukraine
- The concept of implementing a compulsory licensing mechanism in the public health sector in Ukraine
- Report on the analysis of the single-source drugs market in Ukraine
