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Tony DeStefanoTony DeStefano, Ph.D., is the 2013 AAPS president.

 
The ever-increasing globalization of the pharmaceutical industry has enabled patient access to more medicines throughout the world. Globalization has also created more opportunities in new markets for the pharma enterprise worldwide. However, elements of globalization have also created layers of complexity never before encountered based on traditional models for pharmaceutical research and development, manufacturing, distribution, and regulation. More than ever before, standards must play a central role in ensuring the quality, safety, and efficacy of pharmaceutical products made and distributed around the world so that ultimately, the end user—the patient—remains protected.

It’s widely known that some 80% of active pharmaceutical ingredients used to make U.S. medicines today are sourced from outside of the U.S.  Makers, distributors and suppliers of raw materials for drug substances and drug products from China, India, and Brazil are partnering with pharmaceutical manufacturers in North America and Europe as well as other parts of the world. As the first wave of modern protein therapeutics come off patent, we’re beginning to see a rise in collaborations between traditional large pharma and biopharma companies and generic giants from India, China, and Korea as the biosimilar market begins its own global expansion.

Unfortunately, with this propagation of innovation and greater global access to drugs, we’re also seeing the appearance of more counterfeit and substandard medicines in markets around the world. An alarming increase in the number of economically-motivated cases of counterfeits or contamination of medicines is having a direct effect—not only on patients in developing nations most vulnerable to such criminal acts—but also in countries like the U.S. Take for example the appearance in the U.S. of a fake version of the cancer drug, Avastin, the origins of which were traced back to remote sources including Turkey and Egypt.

Although unknown by most of the population, the role played by standards—whether in the pharma or any other globalized industry—is vital for delivering to consumers the high quality products they have come to expect. In the case of pharmaceuticals, our industry and its practitioners must be diligent in taking whatever measures are needed to ensure that our products are safe and efficacious. By adhering to standards for drug quality, and process standards related to drug packaging, storage, and distribution, while working with reputable and responsible suppliers, contract organizations, and other commercial sources throughout the world, those of us in the global pharmaceutical community—in partnership with national governments and regulators—can play a significant part in protecting global public health.