Making Oral Opioids Available in Eastern Europe and Central Asia: the industry speaks out.

Categories: Policy.

Organised to coincide with the 56th session of the UN commission on Narcotic drugs and co-sponsored by the International Palliative Care Initiative (IPCI) of the Open Society Foundations (OSF), Global Access to Pain Relief Initiative (GAPRI), the Worldwide Palliative Care Alliance (WPCA) and the Pain and Policy Studies Group (PPSG) at the University of Wisconsin, 50 participants gathered in Vienna, to explore the challenges that hinder access to oral morphine for pain treatment in Ukraine, Tajikistan, Kyrgyzstan, Kazakhstan and Armenia and to discuss approaches that can be used to address these challenges. Representing the pharmaceutical industry, five companies that manufacture oral morphine products including; Interchem SLC, I. Molteni& Co, RusanPharma Ltd, Verve Human Care, Covidian AG attended the meeting.

Presenting the access challenges, it was noted that as former soviet republics all the five countries have similar prohibitive policies which severely limit access to morphine. The country representatives shared their challenges which ranged from drug registration procedures, prescribing policies, attitude of health professionals, drug control processes and geographical locations of patients. For example, in Kyrgyzstan injectable morphine is only accessible to patients with stage 4 cancer disease and the prescription amount and duration is limited to 20 vials of morphine for 10 days and regulated to a maximum of 300 vials per year.

In Tajikistan, injectable morphine is also the only available form of morphine and it is controlled through 16 regulation documents which make it severely complex to navigate. Moreover, with the mountainous regions landlocked for eight months per year due to severe winter conditions, this creates an additional barrier for patients to access this vital medication as they cannot self-administer the injections and health professionals cannot reach them. 

Armenia has seven types of analgesics, but similar to the rest of the countries, they too only have injectable morphine and access issues are similar to those of Tajikistan. 

Kazakhstan’s injectable morphine is also allocated via a quota system and reaching less than 1% of those who need the medication. It was also noted that there is an imbalance between the control of narcotics for medical use and combating access to illicit drugs. Addressing this imbalance will improve access issues but will require education and awareness among the local authorities. 

While injectable morphine is sufficient to address severe pain in acute cases, for chronic severe pain  palliative care experts recommend  the use of oral morphine as in many cases it is easier to self-administer and can be used around the clock as needed. In the countries mentioned here, oral morphine is not available and therefore it is hard to achieve good pain control. 

Addressing this discrepancy, Ukraine has registered the production of oral morphine in tablet form, this paves the way for better pain management in Ukraine. However representatives from Ukraine noted that they still have to address prescription challenges and attitudes towards morphine use among health professionals and drug control agencies.

Despite the challenges mentioned, further discussions on the level of need for morphine in the five countries showed that the region has a low need and therefore supply could be achieved fairly quickly if the right systems are in place. Market forecasts tabulated by GAPRI indicated that a supply of 74 kg of morphine could fulfil the current gaps in pain medication for those who need it in the five countries. 

Responding to the challenges presented and to the market projections, the pharmaceutical industry noted that the size of need is too small to motivate the industry to navigate the complex and tedious opioid registration procedures. The pharmaceutical representatives went on to highlight several challenges that hinder industry involvement in opioid supply, these include:

  • doctors not ready or willing to prescribe resulting to low demand
  • registration standards that require drug samples for quality control but with no clear procedures for sample importation
  • international drug registration requirement for continuous need for quality control for medications produced more than 4 years ago, a category which morphine falls into
  • countries not knowing how to issue import licenses and creating tedious and bureaucratic processes which could be expensive with no matched returns on investments
  • sometimes no clear understanding between the narcotic bureaus and the registration board with regard to drug control procedures
  • limited or small orders that are not cost-effective to produce
  • lack of ownership at the government level
  • transport issues, especially regulations for transit countries as some countries do not allow transit of narcotics and this is difficult for countries that have no direct access routes
  • morphine’s demand is too low and therefore a risky product from a business point of view and therefore the industry might see it as more of a social duty and many might be unwilling to undertake the social duty.

Discussions with the competent authorities confirmed that there was perhaps an over emphasis to keep illicit drugs out of the countries and this might have had an indirect impact on access to opioids for medical use. They however noted that there is an understanding that opioids are required to address severe pain. With this they emphasized the need to harmonize the regulations and to use the systems in place as benchmark for development. They also noted that it was important for countries to also explore ways to balance and accommodate the interests of manufacturers in line with the World Health Organization guidelines.