Systems: Medicines, Vaccines and Technologies

According to the WHO, a “well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and cost-effective use”.  In 2007, the pharmaceutical industry racked up revenues of $643 billion, with almost half of that generated in the United States.  Not so for long: emerging markets are some of the fastest growing sources of drug expenditures, with revenues nearly doubling annually.  Pharma is one of the fastest-growing, most profitable industries in the world.  

In contemplating the WHO definition of medicines within a health system, it occurred to me how little attention is paid by the average American consumer to the origins of our drugs and the system which ensures quality and safety.  Although media attention is quickly given when drugs are found to be unsafe or excessively costly, the actual functioning of the system is something that we take, relatively, for granted.  My last purchase of medicine was from a suburban pharmacy: I brought my prescription to the counter, exchanged a few pleasantries with the pharmacy assistant, paid for my medicines and went home to take them with a glass of water.  I did not worry about counterfeit substitutes, safety issues or even whether or not it would make me feel better.

This is in stark contrast to the supply chain in other countries where legitimate drugs are often the exception rather than the rule.  I just got off the phone with the Chief Operating Officer of a foundation which sets up shops providing essential drugs for families.  Sub-standard and counterfeit drugs, which comprise nearly 50% of the Kenyan market, are one of their biggest concerns.

What is the system that regulates and ensures the quality, safety and efficacy of our drugs?

• Quality.  Generally-speaking, this is a national responsibility, but early in our modern medical history, national regulation became cumbersome and international standards were sought.  The current international standards system was nearly 100 years in the making, launched in 1865 at the First International Pharmaceutical Congress and culminating in the first international nomenclature adopted in 1951.

• Safety and efficacy.  Drugs in the US go through an approval process overseen by the US Federal Drug Administration (FDA) which regulates both the safety and efficacy of new drugs.  In the EU, this process is overseen by the European Medicines Agency (EMEA) and it is similar.  There is a widely debated trade-off between speed and safety; speed in this case can be equated to both lives saved and Pharma profits gained. 

How do counterfeit drugs make it on the market?  First, let’s not confuse counterfeit with generics.  There is a large and growing market for generic drugs that are manufactured from unpatented compounds or compounds whose patent have expired.  This market is legitimate and good since it drives down the cost of drugs so that more people can have access.  Counterfeit drugs, on the other hand, are drugs which are expired or which are illegally manufactured, often with inappropriate or dangerous levels of substances.  Some estimates show that 10% of all drugs on the global market at any given time are counterfeit, creating a more than $32 billion industry.  Most counterfeits are manufactured in India and China.

New initiatives are underway to mitigate the traffic of counterfeit drugs, including an electronic platform to verify the validity of drugs via sms.  Check out ePedigree.