Latvia: CD4 cell count case
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23.10.2012

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"<...> Any therapy (including that of the HIV infection) in Latvia has to be carried out meeting the requirements of the Article 9 of the Medical Act, Part One, which states: A therapy is being carried out in line with the clinical guidelines, methodical recommendations or assessment of drug safety, therapeutic efficiency and therapeutic methods used, which obeys to evidence- based medical principles. Its Part Two states that clinical guidelines are being developed, evaluated, registered and introduced in accordance with the order established by the Cabinet of Ministers.
The publicly available information witnesses that in the years 2004 and 2009, the State agency "Latvia’s Centre for Infection Diseases" (hereinafter - LIC), developed HIV infection’s treatment guidelines.   Notwithstanding, within the register and database of the National Health Service, there is no record that these LIC guidelines have ever been developed, evaluated, registered and introduced in accordance with the order established by the Cabinet of Ministers.  Therefore, it is reasonable to rule that these guidelines in Latvia are non- existent.
Under these circumstances, HIV treatment in Latvia should be performed in accordance with the assessment of drug safety, therapeutic efficiency and therapeutic methods used, which obeys to evidence- based medical principles.  With further advances in medical science, it is self- evident that doctors should apply a therapy that has sufficient present-day evidence on its efficiency and safety.
In 2009, the Centre for Economics in Health Services, in collaboration with the State agency LIC developed “the Recommendations on rational pharmacotherapy for antiretroviral HIV / AIDS treatments, paid from the federal budget”. It was stated in these Recommendations that they had been prepared using the WHO recommendations’ "HIV / AIDS protocols on treatment and care in the European Region (2007; partially revised in 2008)" clinical protocol Nr. 1: "Patient evaluation and antiretroviral treatment of Adults and Adolescents."
The above recommendations, in particular, established the initiation criteria of HIV infection’s therapy, or antiretroviral therapy (hereinafter - ART).  According to the medical evidence available at that time, these 2007 - 2008 WHO recommendations established that the application of ART in adults and adolescents is to be initiated assessing CD4 cell count per 1 mm3 of blood: At the CD4 cell count of less than 350/mm3 and depending on the clinical stage, the ART initiation was just to be considered. While at the CD4 cell count below 200/mm3, the ART was to be definitely initiated.  Because of the limited health care budget, the Centre for Economics in Health Services determined that the ART is to be initiated only when the CD4 cell count falls below 200/mm3.
Nevertheless, it has to be considered that in 2010, WHO issued new ART initiation recommendations, supported by the findings of several randomized clinical trials.
According to these recommendations, ART is to be initiated for all HIV-infected patients at CD4 cell count less than 350/mm3.
In addition, these recommendations were estimated by WHO as strong, and of moderate evidence level, which means that the previous trials have confirmed that the potential benefits under the new recommendations are greater than the potential harm, and that further trials would very probably support the positive effects of these recommendations. The World Health Organization admitted that following these recommendations, it is feasible to reduce HIV- related mortality by as much as 20%.
Unfortunately, the Latvian State authorities have so far failed to adopt these 2010 WHO recommendations.  Under such circumstances, pursuant to the Article 9 of the Medical Act, Part One, Latvian doctors have to adapt to the assessment of drug safety, therapeutic efficiency and therapeutic methods used, which obeys the latest medical evidence – consequently, the 2010 WHO recommendations.   From the judicial point of view, if the State health officials supplement the health care providers’ contracts with outdated recommendations, thus forcing providers to follow them, then such an action is to be deemed as improper. In that way, health care providers are illegally forced to observe outdated recommendations, thus trespassing against the law.
It is well understood that observing the 2010 WHO recommendations would call for additional expenses. However, by deciding not to introduce the latest recommendations, the State had to prove that the expected financial gain could be considerably higher than the gain from a decreased mortality of HIV- infected persons.  In this case, the fact that HIV and AIDS prevalence rates in Latvia are among the highest in the European Union should not be ignored.  Moreover, if the 2010 WHO recommendations were not implemented as of January 1st, 2013, Latvia would prove to be the only European country where HIV- infected patients do not receive the early treatment (i.e., treatment initiated at the CD4 cell count below 350/mm3).<...>