To Limit Counterfeits, Build a Solid Channel Strategy

Over the past week, I've looked critically at the counterfeit Avastin situation. See Greedy Physicians Invite Fake Avastin Into the Supply Chain and What's Behind Counterfeit Drug Demand.

Today, I take a more normative approach by describing elements of commercial channel strategy that support product security and reduce the risk of counterfeit infiltration. In my experience, a good channel strategy complements such traditional anti-counterfeiting tools as package design, security features, pedigree, track-and-trace, and aggressively prosecuting the bad guys.

Below, I discuss the rationale for limited networks for specialty drugs and provide 6 channel strategy guidelines that manufacturers can use to improve product security. Please add your own suggestions below.

LIMITED NETWORKS FOR SPECIALTY DRUGS

An important feature of specialty pharmaceutical channels is the widespread use of limited distribution arrangements. Most pharmaceutical manufacturers limit the number of specialty distributors that are authorized to distribute their specialty products and the number of specialty pharmacies authorized to dispense their specialty products.

There are many good reasons to create limited networks:

• Specialty drugs serve relatively small patient populations, so a manufacturer can efficiently reach the entire market with a limited number of channel partners.
• Specialty drugs have special handling and storage requirements, such as temperature control. Only distributors that meet a manufacturer’s criteria should be allowed to inventory and dispense these complex, delicate therapies.
• For physician-administered drugs, manufacturers need distributors with the distinctive capabilities required to efficiently and effectively serve patients, providers, and payers. Medical practices require very different services than a retail pharmacy.

Product security is another motivation for limited networks. The risk that a drug could be sold outside its intended distribution channels—known as “diversion”—supports limited distribution arrangements for specialty pharmaceuticals. Secondary markets for pharmaceuticals can develop to arbitrage price differences between different classes of trade or countries. Specialty pharmaceuticals are especially vulnerable given the relatively high expense of specialty drugs. To reduce the risk of diversion, a manufacturer of a specialty pharmaceutical must know and trust its channel partners.

For more detailed explanation of limited networks for specialty distribution or specialty pharmacy, please see the 2011-12 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors (Chapter 3) and the 2011-12 Economic Report on Retail and Specialty Pharmacies (Chapter 8).

USING CHANNEL STRATEGY TO SUPPORT PRODUCT SECURITY

Free advice is worth what you pay for it. Nonetheless, here are six recommendations for building a channel strategy to support product integrity.

Create a limited distribution network for specialty products. Given the risks of diversion, a manufacturer of a specialty pharmaceutical should work with a limited number of highly trustworthy partners. The number, type, and performance criteria will vary based on such factors as market coverage requirement, capability analyses, competition, etc.

Contractually require direct purchasing only. Distributors must agree to purchase 100% of products from the manufacturer. Failure to comply is grounds for termination. This is pretty much standard language these days, after the problems of the pre-2005 forward-buying era forced major wholesalers to give up secondary market trading. Still, make sure your agreements are solid.

Contractually define the channel’s available market. Manufacturers should contractually specify the markets and buyers to which a distributor may sell, limiting a distributor’s ability to resell to other buyers. In practice, pharmaceutical manufacturers should include own-use resale provisions in contracts with specialty distributors or specialty pharmacies. For example, a specialty distributor may be permitted to sell products to physician offices but not to sell products to a pharmacy or another distributor. Specialty pharmacies must agree to dispense products only to patients and not sell to physicians.

Educate providers on the list of your product’s authorized distributors. In addition to product knowledge, a manufacturer's sales reps should understand how products and money move through U.S. drug channels. Then, the reps must explain the authorized channel and its strategic rationale to providers. Providers should know that purchases from non-authorized are wrong and dangerous. (BTW, I’ve developed and delivered in-person and e-learning training programs, so send me an email if you’d like to discuss how to get your field force up to speed on this topic.)

Make it easy to find the list of authorized distributors. Put information about the authorized channel front-and-center on the public web sites aimed at providers and pharmacies. I visited the web sites of the top specialty drug manufacturers, a number of which are my clients. Frankly, I'm surprised how hard it is to find a list of authorized distributors on certain sites. (Sorry, no names!) It's not easy to find the list on on product-specific sites, either.

Reward the channel for educating providers. Here’s a more speculative idea. When creating a specialty distributor agreement, build a pay-for-performance metric linked to providers’ awareness of the manufacturer’s limited distribution network. I haven't seen such a metric in any contract, but there's no reason something couldn't be developed.

While nothing can completely stop rogue medical practices that put profits over patients, these 6 steps will reduce risks and strengthen the channel system. Can you do it? Yes you can!

Any other suggestions?