ADVOCACY of innovative drugs into the global market over the past 20 years established a presence in Macedonia . In practice , they are not direct distributors of their own program ; the distribution is done by wholesalers , their local partners . Local representative offices of big pharma companies mainly deal with aftersales activities , analysis of the use of their drugs , marketing activities and the like .
Generic drugs are of good quality , but how to get more innovative drugs on the positive list ?
Parallel Imports Just “ Pour Oil on the Fire ”
Summer 2016 / Issue 50
ADVOCACY of innovative drugs into the global market over the past 20 years established a presence in Macedonia . In practice , they are not direct distributors of their own program ; the distribution is done by wholesalers , their local partners . Local representative offices of big pharma companies mainly deal with aftersales activities , analysis of the use of their drugs , marketing activities and the like .
In recent years , we ’ ve witnessed a trend of big pharma companies closing their offices . Our sources say that the pharmaceutical giants Astra Zeneca , Actavis and Stada already closed their offices and several companies downsized their staff , reducing and refining their basic operations down to basic registration of medicines , etc . The closure of their local offices does not mean that their products will not be present on the market , though , drugs for which manufacturers have no income from the Macedonian market may be withdrawn . These are more expensive drugs that are not on the State Fund ’ s positive list and are not viable for commercial use , given the small market .
“ We all lose from the withdrawal of global pharmaceutical companies from the country . Health workers can ’ t treat patients with new drugs to their benefit . Patients can ’ t participate in sponsored studies , so they can benefit from the latest pharmaceutical achievements . As prices of generic drugs start to fall ( drugs produced after patent protection of the original formula expires , usually ten years after their original placement . The manufacturing cost of these drugs is much lower because costs of research and development are not embedded ), profits will decrease and we will lose the margin that usually supports the import of innovative medicines ,” according to our sources .
What kind of drugs are Macedonian citizens treated with ?
Generic drugs are of good quality , but how to get more innovative drugs on the positive list ?
Do cheaper , generic , outdated medicines , with formulas synthesized 20-30 years ago , dominate the market ?
Pharmacists with whom we spoke said that drugs in Macedonia have the required quality and are safe , at least those that enter legally ( i . e ., following the required procedures of registration , distribution , storage , etc .). The Medicines Agency has stated repeatedly that citizens can sleep peacefully : drugs entering the market under their control are safe in every way . The generic drugs policy used by the government does not mean that drugs lack quality , pharmacists explain . These are drugs that are made by a formula that was invented by major pharmaceutical companies / market innovators that initially had exclusive rights to market the formula , before other companies obtained the right to produce these drugs under license . These new drug innovations are expensive because several billion dollars are usually spent in research and development of the new drug molecule .
After the patent protection period expires , all generic companies in the world can produce their own drug and under their own brand , based on the new formula . Treatment with innovative drugs is expensive , therefore , global practices regulate the drug market , aiding public procurement policies and subsidizing innovative drugs , so they are available to the population .
Continued on page 24
Parallel Imports Just “ Pour Oil on the Fire ”
Four years ago , the State began allowing parallel imports of medicines , meaning the ability to import a drug that is already registered in Macedonia , but is found cheaper in the list of countries that allow parallel imports . Minister of Health , Nikola Todorov , defended this measure stating that it will allow increased market competition and cheaper drugs for patients . Representatives of wholesalers say that the interest in this list increased as soon as Russia and Turkey were added to it - because of the size of these markets and the possibility of finding lower-priced drugs - domestic wholesalers began to import more drugs with this type of import . We received a similar perspective from several pharmaceutical workers , managers and wholesalers offices of global pharmaceutical companies about the consequences of parallel imports : a ) They impede the traceability of drugs , from the manufacturer to the end user in Macedonia ; b ) They increase the likelihood of counterfeit medicines entering the market , particularly from markets outside the EU , Russia and Turkey ; c ) They circumvent the major pharmaceutical companies worldwide , further reducing the attractiveness of the Macedonian market for them . Our sources state that there are sufficient regulations to reduce prices and that parallel imports aren ’ t necessary , since many drug prices are already reduced to levels that are unattractive to manufacturers and wholesalers . It is worthwhile to note that for the purpose of this text , we sent questions to the Medicines Agency for their position on parallel imports and their effects , as well as to comment on not having new innovative drugs added on the positive list , but did not receive an answer .
AMCHAM MAGAZINE 17