“Don’t Touch My Bags If You Please, Mr. Customs Man”

protection (only relevant in countries that honor this). They will weigh a number of factors, including whether similar treatments are already for sale in their country as well as the number of people in their own region that would likely benefit from the drug. The incidence of particular diseases varies greatly in different parts of the world, and if the disease you have is not prevalent in China or India, for example, then there would be little incentive to manufacture a drug to treat it in that country.

Location—My scenario above has my imaginary patient flying to China to buy Chinese made drugs. Some less worldly travelers might find this lengthy trip intimidating enough to stay home. But suppose these drugs were made in China or India and then exported to a country closer to the U.S., like Mexico, where buying them would be much more convenient? Would that increase the likelihood of this scenario happening? Since drugs are much easier to export than hospitals equipped with trained doctors, this is a significant difference from the flying-to-have-surgery setting described above.

Cost—This is likely to be the most important factor. Finding out how much drugs cost here in the U.S. is surprisingly difficult (go to Google right now and try it). Let’s do a quick case study with etanercept (Enbrel), ranked by EP Vantage as the best-selling biologic in the world with 2008 sales of $6.46 billion. Etanercept, a soluble TNF inhibitor developed by Seattle’s Immunex (since acquired by Amgen) is used primarily for treating rheumatoid arthritis and psoriasis. In the U.S., this drug is usually dosed at 50 milligrams a week. My local drug store put the cost at about $26,500 a year; at drugstore.com the cost was about $21,400 a year. In China, a version of this drug, known as Yisaipu, lists for $64 for 12.5 mg. This works out to $256 for the same weekly recommended dosage in the U.S., or a yearly cost of $13,312. Assuming your travel expenses are under $2,000, then one could still save between $6,000 to $11,000 a year by buying this drug in China. Buying this drug in Mexico, where it is apparently exported, would save significantly on the travel expenses. This looks like a pretty significant savings, although still a very large expense. Manufacturing biologics, even in China, is an expensive enterprise.

Quality—If you’re going to pay thousands of dollars to purchase drugs overseas, you’ll want to feel confident that what you’re buying is up to snuff. First off, are you getting the real deal? A vial full of reconstituted proteins looks no different than a vial of water. Does the vial contain the drug

Author: Stewart Lyman

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides advice to biotechnology and pharmaceutical companies as well as academic researchers and venture capital firms. Previously, he spent 14 years as a scientist at Immunex prior to its acquisition by Amgen.