Showing posts with label International Drug Channels. Show all posts
Showing posts with label International Drug Channels. Show all posts

Monday, June 23, 2008

Attacking Repacking

Please take a moment to read Peter Pitts’ comments about the dangers of repackaging pharmaceuticals in Europe:

Repack Attack

Massive cross-border diversion in Europe (a.k.a. parallel trade) creates entry points for counterfeits or mishandled drugs. In fact, seizures of counterfeit drugs at the EU border rose 51 percent last year compared with 2006 according to a recent European Commission report. (See “medicines” data on page 18 of Report on Community Customs Activities on Counterfeit And Piracy.)

Nevertheless, repackaging by parallel importers and exporters in Europe can remove anti-counterfeiting security technology on a package, including the serial number. Huh??

Click here to read the official press release from the European Federation of Pharmaceutical Industries and Associations.

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My review of Accenture’s track-and-trace report will appear tomorrow.

Friday, June 13, 2008

Shopping for Counterfeits

Looking for something fun to do on your summer vacation?

How about going to Hong Kong to buy counterfeit drugs?

Well, that’s exactly what Sharon Flank of Infratrac did. Even better, she wrote Anticounterfeiting And NIR: A Hong Kong Diary, a very entertaining account of her adventures that was just published in Pharmaceutical Manufacturing magazine.

Skip the first part of the article and jump to the fun part, which begins with the heading “Shopping for Counterfeits in Hong Kong” (at the bottom of page 1).

Dr. Flank's personal search for counterfeit drugs in Hong Kong makes a great read. Here’s a neat excerpt in which she explains the advice on counterfeit detection offered by one Hong Kong shop owner (named Penrod Pooch?):

“I asked how to tell which shops had counterfeits. Would they be the ones without a ‘No Fakes’ pledge or authorized dealer stickers? Not at all: if you buy even one pill legally, you get a sticker, and the rest of your inventory may not be genuine. Price is the key. The profit margin on pharmaceuticals is thin, about HK$10, a little more than a dollar. So no one will bargain much on genuine product, because they’d lose money. He suggested that I offer to buy five or six, and see if the price started to move.”

SPOILER ALERT: By the end of the article, she has successfully purchased fake Viagra and some alleged Cialis made by “Lieel” (!).

All in all, this article is an intriguing and scary first-person account that will enlighten anyone who believes that counterfeit drugs are not a threat. John Lechleiter, President and CEO of Eli Lilly, got it right in yesterday’s widely-cited Bloomberg article: “It’s a big issue, it’s a global issue, it’s an insidious issue.'”

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Take a quick tour of great health care policy blogging from around the web in the latest Health Wonk Review edited by Jane Hiebert-White for the Health Affairs blog. Thanks to Jane for citing my recent extra-wonky posts on AMP!

Thursday, March 20, 2008

The FDA and EC Dive into Supply Chain Security

Today, the Food and Drug Administration (FDA) began soliciting comments and information about technologies behind pharmacy supply chain security. Here are the links for your commenting and informing pleasure:

Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs (Request for Comments)

Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication (Request for Information)

In an interesting coincidence of timing, the European Commission (EC) recently made a similar request regarding closely related issues. See the EC’s just-issued Public Consultation In Preparation Of A Legal Proposal To Combat Counterfeit Medicines For Human Use.

These requests provide a good opportunity to educate regulators about the progress being made in our industry along with the real-world implementation hurdles. So far, the clarity and professionalism of the questions posed by the EC and FDA offer an interesting contrast with a certain Board of Pharmacy’s approach to information gathering and assessment.

What’s Going On?

In the U.S., states currently have the greatest influence over the wholesale and retail distribution of drugs, presenting some practical hurdles for any manufacturer, wholesaler, or pharmacy that operates in multiple states. Say hello to 50 different pedigree requirements!

Last September's Food and Drug Administration Amendments Act of 2007 (or FDAAAAAAAAAAA) empowered the FDA to take a stronger hand in these matters with Section 913, entitled “Assuring Pharmaceutical Safety.” Download this handy-dandy 2-page extract to read this section for yourself. I first discussed the importance of this Act in PDUFA & Supply-Chain Security.

In plain English, Section 913 requires the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The deadline is March 2010. The most notable requirements include:

  • The development of a standard numerical identifier at the package or pallet level; and

  • The evaluation of “promising technologies,” including RFID, nanotechnology, encryption technologies, and “other track-and-trace or authentication technologies.”
Well, this first item should be a breeze since we are only 9 months away from having all products sold in California serialized at the unit of use level for use in e-pedigree, right? Just kidding! (I’ll have more on the CA 2009 deadline next week.)

Let’s Get It On

I’ll admit to being just a wee bit critical of the FDA’s love affair with RFID. As I see it, the FDA has not always demonstrated an understanding of business realities within the pharmacy supply chain. Drug Channels readership has grown dramatically in the past year, so new readers may want to check out two RFID posts from a year ago: RFID Un-Hype and More RFID Un-Hype.

Back in June 2006 (when I had about 11 subscribers), I wrote that the FDA was blind to the supply chain’s evolution, stating: “I guess it’s easier to blame companies for not spending enough money on premature solutions than to understand the real-world complexity of having 160,000 unique points of drug dispensing.” Hopefully, we’ve all come a long way since then.

Comments are due to the FDA by May 19, 2008 and due to the EC by May 8, 2008. Happy submitting!

Wednesday, January 16, 2008

AstraZeneca's Direct-to-Pharmacy Model

Following in Pfizer’s footsteps, AstraZeneca UK formally announced that its direct-to-pharmacy distribution arrangement will begin on February 2, 2008.

Click here to read the letter notifying pharmacists of the switch and explaining the new discount structure. As you can see on page 3 of the letter, discounts are determined by AZ based on brand product instead of being set by competition between wholesalers. The Office of Fair Trading (OFT) report on Medicines Distribution worries about the competitive effects of manufacturer-controlled discounts with DTP models, writing:

"Under DTP schemes, manufacturers set the prices paid by pharmacies and pay wholesalers a fee for delivering their medicines according to their required service standards. There is no convention covering the level of discounts to pharmacies in these circumstances."

I wonder if DTP will be sustainable as more manufacturers adopt the model. At some point, it will simply be more efficient for a pharmacy to buy from a traditional, full-line wholesaler. A UK pharmacist lamented the practical realities of DTP after Pfizer's announcement, writing:

"Oh, and spare a thought for us poor overworked pharmacists. At present I only have to deal with one wholesaler, a regional independent wholesaler which is part of the company I work for. If anything is out of stock at the warehouse it is automatically ordered from Unichem or AAH by head office. My life is very simple at present. If Astra Zeneca use AAH as their delivery agent, and Sanofi choose Phoneix, Lilly someone else and Novartis yet another company, then ordering will be made so much more complicated and time consuming. And it's not like I don't have enough things to do as it is."

The Pharmaceutical Services Negotiating Committee (PSNC), a trade group of UK retail pharmacies, has a useful list of recent UK distribution changes by manufacturers. The UK DTP experiment will give us some useful insight into U.S. prospects as more manufacturers launch programs.

Wednesday, December 12, 2007

U.S. Lessons from Pfizer UK

The UK Office of Fair Trading (OFT) just released its report on the new direct-to-pharmacy (DTP) distribution model being used by Pfizer and Alliance Unichem.

Their bottom line: Control of distribution could allow Pfizer to profit at the expense of the UK government, which might end up paying “hundreds of millions of pounds a year.” The headlines have predictably focused on this rather theoretical conclusion. (Example: OFT says new drug deals could cost NHS millions in the Times of London)

The more intriguing story are the reasons *why* the British government (a single payer) dislikes Pfizer’s plan. As I explain below, I think that the OFT report gives us fresh insight into why U.S. payers will care more about U.S. manufacturer channel strategies in a world of cost plus, Average Manufacturer Price (AMP) based pharmacy reimbursement.

Nudge Nudge

I’ve been covering Pfizer’s plan since it was announced 15 months ago and recently gave you some behind-the-scenes insights from the Director of Commercial Operations at Pfizer UK. You can read Pfizer’s description of the program on their UK web page.

Here’s some brief background to help you understand the following OFT report materials:


In the UK, manufacturers give wholesalers a discount of 12.5 percent off list price. Competition between wholesalers means that wholesalers pass 10.5 percent of their discount (84%) to retail pharmacies. Wholesalers get reimbursed for dispensing by the UK government’s National Health Service (NHS) based on list price.

However, the National Health Service (NHS), which is the UK government payer, gets to clawback any “excess profits” that a pharmacy earns from high discounts. This mechanism allows the single government payer to pay below list price because it shares in the financial gains of savvy purchasing by pharmacies.

The Ministry of Silly Reports

The OFT fears that the DTP model will reduce wholesaler competition, thereby shrinking the discount off list offered to pharmacies. The NHS would end up paying “hundreds of millions of pounds a year” because there will be less for the government to clawback from pharmacies. The OFT is also concerned that manufacturers will try to save money by reducing service levels to pharmacies and ultimately patients.

The core reasoning behind OFT’s anti-competitive fears appears in section 5 (pages 73-83) of the full report. It’s somewhat slow going, especially because the arguments are made without specific data or quantification.

Critically, the OFT does not recommend anything stronger than “monitoring the situation.” Translation: These (so far) theoretical concerns do not merit any formal actions.

And Now For Something Completely Different

The UK discounting dynamics will sound familiar to U.S. market participants. Here in the U.S., drug makers give certain discounts or fees only to wholesalers. The large buyers play the wholesalers off against each other and extract most of these discounts and fees. Just look at the recent negotiations between Cardinal Health (CAH) and CVS for an example.

But unlike the UK, U.S. pharmacies get to keep any extra profits gained from squeezing the wholesaler. “AWP minus” reimbursement creates powerful incentives for pharmacies to seek lower drug prices from their wholesale suppliers. Medicare and Medicaid do not financially benefit from higher spreads at the pharmacy level.

In contrast, an “AMP Plus” model would create a very different dynamic for a payer, who would share in the financial benefit from any reduction in Average Manufacturer Price (AMP). Thus, any manufacturer-led distribution changes that reduced competition for manufacturer discounts from direct buyers (wholesalers or pharmacies) would be opposed by payers.

Here in the U.S., payers have shown a willingness to alter drug distribution as a means to reduce costs. (Just look the growth of mail order.) I’m not suggesting that payers will suddenly care about a manufacturer's fee-for-service agreements or the number of authorized distributors. But I am suggesting that AMP will make them care a lot more than they do now.

Tuesday, November 06, 2007

Behind the Scenes of Pfizer UK

I’m blogging to you from the 2007 PharmaLink conference in Las Vegas. I’ll be speaking on Tuesday about the future of manufacturer-wholesaler relationships.

Today, I heard a fascinating presentation from Steve Poulton, Director of Commercial Operations for Pfizer UK. He explained how Pfizer shifted from selling through wholesalers to selling directly to dispensers using a single wholesaler as a logistics partner (Alliance Unichem).

I’ve been covering Pfizer’s strategy in previous posts (See Pfizer's UK Deal: Change is Here! and Pfizer wins again). Briefly, Pfizer now pays a per-package logistics fee to one wholesaler to distribute its products to pharmacies, hospitals, and dispensing physicians in the UK. Customers are purchasing from Pfizer, even though Alliance Unichem handles ordering and fulfillment.

Steve provided a lot more detail on the mechanics and costs behind Pfizer's strategy shift. A few interesting things that I learned:

  • Pfizer spent a lot of time and money setting up this program. There were many (10?) internal teams plus a steering committee. Total time from conception to "go live" was more than 3 years.
  • Over 22 million packs have been delivered since the program began.
  • Service levels to customers—defined as “on time, in full” deliveries—are now running at 99.4%, which is higher than when Pfizer used to sell through wholesalers. Hence, there have been very few actual customer complaints.
  • Pfizer did not intend to use only one wholesaler. However, AAH was told by its parent company (Celesio) to withdraw from contract negotiations. Phoenix, the third large UK wholesaler, apparently did not submit a proper response to the original RFP. Ironically, both AAH and Phoenix are now working with other manufacturers on logistics deals.
Clearly, the title of my most recent post on the UK situation was not accurate in stating Pfizer's UK Plan in Trouble. In particular, Steve claims that the use of a single wholesaler is not a problem because the government is only concerned that (a) costs to the National Health Service don’t go up, and (b) patients can still access Pfizer drugs.

Despite these positives, I’m still skeptical that Pfizer’s plan will stop counterfeits. UK pharmacies can still choose to be naughty and purchase parallel import or gray market products. Pfizer can guarantee the security of its own supply chain but can not force pharmacies to buy through the legitimate channel. Once again, pharmacies are the weak link in guarding the supply chain against counterfeits—a demand-side security problem that just won’t go away. (Sorry, pedigree fans.)

I also want to add that a Pfizer-type arrangement would be much, much more difficult here. There are only 15,000 points of dispensing over there compared to 150,000+ in the US. I saw a few US executives stop taking notes once Steve talked about the organizational and financial realities of direct distribution.

All in all, this was a great behind-the-scenes peek at an apparently successful channel redesign. Wish you were here!

Friday, October 19, 2007

Pfizer's UK Plan in Trouble

Pfizer may have to end or amend its exclusive distribution deal with UniChem, the wholesale arm of Alliance Boots (AB), under proposals being considered by the Office of Fair Trading (OFT). See Pfizer May Have To Unpick Exclusive Distribution from the Times (London).

Pfizer’s new plan (first discussed here last September) has at least two primary objectives: (1) Lower the risk of counterfeit products entering the supply chain, and (2) Recapture lost revenue from parallel importing.

My prediction: The OFT will require Pfizer to expand its network to at least one other wholesaler, but not require them to sell to all wholesalers.

In March, the UK wholesalers failed to get a legal injunction to stop Pfizer from implementing its new distribution plans.

Yet wholesalers have been much quieter about the announcements from other manufacturers like Sanofi-Aventis or Novartis, especially since these manufacturers plan to include other wholesalers (AAH or Phoenix). From what I hear, most major drug makers will announce more selective UK distribution plans by the end of 2007.

Frankly, the whole issue really comes down to basic business economics. Manufacturers in many industries can and do legitimately limit the number of wholesalers who are authorized to sell its products. Channel mavens like me refer to the degree of distribution selectivity – from one wholesaler (exclusive distribution) to an unrestricted number of wholesalers within a given market (intensive distribution).

I believe that any excluded UK wholesalers will continue their attempts to stop Pfizer (or others) from implementing strictly exclusive distribution, but will not be able to stop selective distribution.

It’s interesting to note the contrast with the U.S. Here, U.S. wholesalers successfully stopped the FDA from implementing the pedigree requirements in the Prescription Drug Marketing Act. Robert Drucker is probably a hero to any non-selected UK wholesalers given his company’s legal battle against the big three wholesalers and 16 major drug manufacturers. (See RxUSA’s July 2006 complaint for the alleged details.)

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P.S. Readership at Drug Channels is waaaay up since last year. In case you weren’t reading back in August ‘06, here is a background post on European drug channels: Curious about European Drug Distribution?

I discuss the US angle on distribution deals in light of U.S. importation bills (such as S.242) in Will US logistics deals be illegal?.

Wednesday, September 26, 2007

Chinese Take-Out

The Sunday Times (London) has a fascinating peek behind the scenes of a Chinese drug counterfeiting operation. See Factory for Fake Prescription Drugs.

One of their reporters posed as a UK drug wholesaler (!), which was apparently a very convincing disguise. It's easy to locate a counterfeit supplier – just post an online ad. The initial order: 200,000 packs a month of three drugs (Plavix, Casodex, and Zyprexa).

Is this all true? Since the Times reporter is not law enforcement, the Chinese businessman denied making or selling any counterfeit drugs. Of course, he was forced to admit that he did happen have machines to make counterfeits. And the photo gallery for the story shows his factory making much more than the standard Poison Me Elmo dolls. Look carefully at the last few pictures.

The Times says: “One of the problems appears to be Britain’s reliance on drugs bought through parallel trade – the system in which drugs are bought and sold several times because prices vary between different European countries.”

Importation Illusions, I say.

Thursday, September 20, 2007

CAH + AB = ??

Cardinal Health (CAH) and Alliance Boots (AB) just announced an agreement to bring AB’s Almus brand of generic drugs to the U.S. market. See Alliance Boots, Cardinal Health Announce Joint Sourcing and Marketing Agreement.

This agreement could be merely routine – or the beginning of something very significant.

Private Labels Come to Pharma

If Almus is merely another generic supplier to Cardinal, then today’s announcement is only mildly interesting. AB’s success with Almus should not shock anyone who read my new book Facing the Forces of Change®: Lead the Way in the Supply Chain. I found that private label products (products branded by a wholesaler) will be expanding substantially in all industries over the next five years.

The economics are straightforward. A private label generic drug increases profits because the channel captures the margin that would otherwise flow to an upstream generic drug maker. The wholesaler—Alliance Boots in the case—also gains the ability to control the entire profit stream from production to sale, allowing for more flexible internal sales compensation models and higher commissions to drive sales.

Going Global

The big three wholesalers—AmerisourceBergen (ABC), Cardinal Health (CAH), and McKesson Corp (MCK)—already have active private label programs in other parts of their business. In fact, McKesson’s private label EverFRESH toothpaste got caught up in this summer’s tainted food recall after laboratory tests found small amounts of diethylene glycol.

From my point of view, it’s inevitable that wholesalers will be moving closer to production in order to source products for which there is limited brand preference. It’s not a stretch to imagine the combination of a generic manufacturer and wholesaler.

Seen in this light, today’s announcement may signal that Cardinal is gaining a bigger foothold in the global sourcing market. Such a move would give them the opportunity to sell generics in high volume to large pharmacy buyers sourcing directly from generic drug makers. (See CVS' Channel Power.)

Here's another idea to ponder. Alliance Boots recently entered the Chinese market and is planning to enter India. I already warned you over the summer that The British are Coming. So, could this agreement signal the beginning of a more significant relationship between Cardinal and Alliance Boots?

Tuesday, July 31, 2007

News Update: July 2007

Here are some interesting or curious articles about the pharmacy supply chain that didn’t merit their own post in July.

1) E-Pedigree Goes Mainstream
The venerable Pharmaceutical Executive ventured into the supply chain with Pharma Ramps Up for E-Pedigree, an overview of the California e-pedigree situation. The article is generally accurate, although the ratio of actual pharma executives (3) to technology vendors (7) was a bit low. Surprisingly, there are no comments from the pharmacists who will supposedly install systems to read serialized RFID/bar-codes and willingly transmit the information for free to everyone else.

2) Fun with Forrester
My June news update led to an interesting debate with Forrester research analyst Carlton Doty regarding my negative review of his online drug buying study. Make up your own mind by reading our back-and-forth exchange in the comments section below the June post.

3) Why do they put nails in coffins?
Whistleblower Peter Rost allows an anonymous pharma sales rep to post a deeply cynical look at Average Sales Price (ASP) reimbursement for oncology drugs. Caveat lector!

4) UK Distribution Update
Sanofi-Aventis became the latest manufacturer to trim its UK distribution network. In related news, it looks like the Alliance Boots buyout has hits some snags, with banks holding back on the debt sale until the market improves (See Alliance Boots Debt Sale Postponed).

5) Wonky
The new Health Wonk Review, a compendium of health policy blog postings, is worth reading. Plus, they picked up one of my Average Manufacturer Price (AMP) analyses.

6) Chicken Soup for a Pharmacist’s Soul?
You MUST read Welcome to the World of Retail Pharmacy, a poem about life in a community pharmacy. After all, how many poets would dare to rhyme words such as “Rx” or “pseudoephedrine”?

Friday, July 13, 2007

The British are Coming?

Keep an eye on Alliance-Boots, Europe's biggest retail pharmacy and drug wholesaler.

After some boardroom machinations this week, Stefan Pessina is now firmly in charge of Alliance-Boots. See Baker goes as Pessina takes charge after coup at Boots (Times London) or Alliance Boots CEO Resigns (Wall Street Journal).

As you may recall, A-B was formed when Alliance Unichem, Europe's biggest drug wholesaler, merged with Boots, the UK's largest pharmacy retailer. Alliance-Boots was taken private in a leveraged buyout financed by Kohlberg Kravis Roberts and led by ... Stefan Pessina, who was also the driving force behind Alliance-Unichem.

Once the dust settles, what's next?

I predict that the drive for consolidation within the pharmacy supply chain plus private equity's need for mega-deals will lead Alliance-Boots to create a global pharmacy wholesaler and/or retailer within the next three years. Thus, I would not be surprised if:

1. Boots opens in the US -- Boots launched in North America in 2004 and currently sells its products in Target, CVS, and Shoppers Drug Mart stores. While there are no standalone Boots stores here, the brand is starting to become known by consumers. I wonder if CVS will one day regret its decision to let Boots get their, um, foot in the door here. (Doh!)

or

2. Alliance-Boots acquires a US Wholesaler -- As I pointed out in April, Pessina has wanted to create a global pharmaceutical wholesaler for some time, so this is also a credible scenario. The big 3 have strong cash flow and minimal debt, making them catnip for private equity firms. But valuations remain relatively high, so it's hard to put a deal together. A change in sentiment could make the numbers work, especially given the not-so-obvious but still substantial restructuring opportunities in the US wholesaling industry.

Keep in mind that this is all pure speculation. And please don't complain if I'm wrong -- free advice is worth what you pay for it.

Monday, April 23, 2007

Meanwhile in Europe...

The US wholesaler market has been fairly quiet with the exception of regulatory/legal battles over pedigree.

Meanwhile, the European wholesaler market is now undergoing the massive structural changes that I predicted in September. Here's a quick update on three key developments.

LBO Time
The battle for Boots continues, with a rival bidder now challenging KKR’s initial bid. (For background, see Wholesaler LBO Time.) The Sunday Times has a fascinating peek inside the deal called Wrestling over Boots. It also includes a brief history of both Boots and Alliance Unichem.

The Times' business editor is skeptical about the prices being offered (me, too) while noting that Stefano Pessina "...has long-term ambitions to create a global pharmaceutical wholesaler." Hmm....

Consolidation
Meanwhile, Celesio apparently wants to acquire the drug distribution business of Alliance Boots from the winning private equity firm. (See Germans to pounce if Boots is broken up.) Guy Hands, the rival bidder to KKR, is rumored to be planning a break-up of the wholesale and retail units if he wins.

If a break-up were to occur (a BIG if, IMHO), then a combined Alliance/Celesio wholesaler would have more than 60% of wholesaler market share in key countries such as France and the UK. FYI, Europe represents 30% of global pharmaceutical sales versus 48% in the U.S. according to IMS.

AZ's New Distribution Strategy
To add to the excitement, AstraZeneca announced that it is following Pfizer’s model and will limit product distribution to only two wholesalers in the UK. AZ chose the drug distribution arms of Alliance Boots and Celesio, which is ironic given the given the rumors surrounding the Boots deal. Needless to say, the other UK wholesalers are not too happy. (See Wholesaler fury at AstraZeneca drug distribution deal.)

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While I will refrain from specifics, let me suggest that future changes in global wholesaler market structure should not come as a surprise to readers of this blog . . .

P.S. Last Friday's post (RFID Un-Hype) generated record traffic for Drug Channels. Check out the thoughtful comments posted by Kevin Leininger, CEO of Integrichain, and Nick Basta, editor of Pharmaceutical Commerce.

Wednesday, April 04, 2007

Will US logistics deals be illegal?

Yesterday, the UK’s Office of Fair Trading (OFT) announced its intention to study the pharmaceutical wholesaling market in light of Pfizer’s new distribution arrangement with Alliance Unichem. (See OFT's statement on Distribution of medicines in the UK.)

However, you probably don't realize that a similar arrangement in the U.S. between a manufacturer and a wholesaler would probably be illegal if the proposed importation bill (S.242) before the U.S. Senate becomes law. Trade relations and commercial relations executives should pay attention because importation legislation explicitly limits the way a manufacturer can structure its U.S. distribution agreements. (CYA Notice: I'm not a lawyer. Read the disclaimer at the bottom of this page!)

I have been following international drug channels for some time, most recently in A New Era for Distribution. OFT's statement explaining the rationale behind the study states:

“The pharmaceutical wholesaling sector is undergoing significant change, the competition implications of which are unclear. As of 5 March 2007 Unichem Limited has become the sole logistics service provider to Pfizer Limited. This represents a fundamental change to the workings of this sector and has prompted widespread concern among pharmacists, dispensing doctors and competing wholesalers. Other pharmaceutical manufacturers are also considering similar changes to their distribution arrangements.”

In my opinion, Pfizer has at least two legitimate objectives for their deal with Unichem:

  1. Lower the risk of counterfeit products entering the supply chain
  2. Recapture lost revenue from parallel importing
Given these reasons, I believe that the proposed importation legislation would make it illegal for Pfizer to set up a sole logistics provider relationship in the U.S.

In particular, the actions listed as “Unfair and Discriminatory Acts and Practices” in S.242 are clearly modeled upon manufacturers' strategies for managing parallel trade in the EU. (See the section beginning on line 13 of page 74 of S.242 Pharmaceutical Market Access and Drug Safety Act of 2007.) IOW, manufacturers will also have little choice about whether to do business with known US importers or non-US exporters.

Keep in mind that the importation bill is co-sponsored by all three Presidential candidates from the Senate – McCain, Clinton, and Obama. Iraq and the Medicare “direct negotiations” movement will keep the Senate busy this term, but look for action on importation in late 2007 and 2008.

Friday, March 09, 2007

Wholesaler LBO Time

I can't leave for the weekend without highlighting this news story:
  • "Private-equity group Kohlberg Kravis Roberts & Co. and Alliance Boots PLC executive Stefano Pessina said Friday they had made a friendly takeover approach to the health and beauty company for 1,000 pence a share, or about $18.71 billion . . . Alliance Boots was created following the merger of U.K. health and beauty retailer Boots Group PLC and pan-European drugs distributor Alliance UniChem PLC in July."

So, who's next? The good folks at Starshak Winzenburg send me a monthly update on distribution stocks. Here is the enterprise value of the Big 3 US wholesalers according to their March 2007 Distribution News issue:

  • AmerisourceBergen (NYSE:ABC) = $9.9B
  • Cardinal Health (NYSE:CAH) = $29.2B
  • McKesson (NYSE:MCK) = $15.4B
Today's move by KKR may also make you re-consider the last paragraph of my February post Trouble Ahead for Independent Pharmacies. Any takers?

Saturday, March 03, 2007

Pfizer wins again

As expected, the high court in Britain will not stop Pfizer's distribution arrangement with Alliance Unichem.

Since I won't be attending the HDMA business partner exchange meeting that starts next week, I want to offer a few comments on this outcome then and predict what it might mean for the US.

Drug manufacturers have been trying to regain control over their distribution channel in Europe for some time. Glaxo won some notable legal victories last September that paved the way for Pfizer's UK agreement, as I predicted in A Partial Win for Glaxo Means More Change for EU Drug Channels.

Pfizer has been very active over the past few years in asserting its legitimate commercial interests to engage in strategic channel management. Today's high court decision is the second victory against wholesalers in a week for Pfizer. Recall that Pfizer successfully prevented Danish wholesaler Nomeco from selling a generic version of Lipitor.

For now, these attempts are not needed in the US because manufacturers have much more control over the larger wholesalers. US wholesalers still derive a majority of their gross margin from the buy-side via fee-for-service agreements and payment terms.

In contrast, wholesaler sell-side margins are regulated or fixed in most EU countries. Some countries, such as France, even regulate the maximum discounts to these margins that wholesalers can offer to pharmacy customers. As a result, I estimate that manufacturers only control about 25% of the larger wholesalers' gross margin versus 90%+ in the US.

PREDICTION: The likelihood of EU-style channel management efforts in the US will increase if US wholesalers begin to derive a greater proportion of their buy-side margins from activities that are not controlled or compensated by branded manufacturers. (This is the underlying theme of my Generics=Channel Strife? post).

Check back in 12 months and see if my prediction comes true.

P.S. BTW, I received many emails on Thursday's post (Generics=Channel Strife?), most of which asked for clarification or a customized analyses. If you are not one of my advisory consulting clients, I'd prefer that you post your question as a public blog comment. Naturally, you can also feel free to inquire about the services offered by your friendly neighborhood blogger...

Friday, March 02, 2007

A New Era for Distribution

We seem to be entering a new era for the pharmaceutical distribution channel – one in which the regulatory “rules of the game” become more important than ever for marketplace success.

Back in September, I wrote about Pfizer’s UK drug distribution deal with Alliance UniChem. (See Pfizer's UK Deal: Change is Here!.) As I noted, Pfizer, has two legitimate objectives for this deal:

  1. Lower the risk of counterfeit products entering the supply chain
  2. Recapture lost revenue from parallel importing
Now, a group of UK distributors is seeking an injunction against this new strategy on the eve of its introduction next Monday. (See Drug wholesalers go to court to block Pfizer deal). I don’t know enough about UK law to handicap the outcome.

But in reading this article, it strikes me that we are seeing more wholesaler-to-wholesaler conflicts playing out in the legal and public policy realm. Last year saw secondary wholesalers successfully block the FDA’s implementation of the PDMA with a Federal injunction. (It's Official: PDMA is Back On Hold). RxUSA, the wholesaler who lead that effort, is simultaneously pursuing legal actions against McKesson, many manufacturers, and the HDMA. There was also friction surrounding Florida’s pedigree law between the large drug wholesalers, secondary drug wholesalers, and med/surg wholesalers. (See H.B. 371 signed by Gov. Bush ).

I’m not ready to draw a firm conclusion about all of this activity yet. But I wonder if we are now at an inflection point for the drug distribution industry.

Thursday, March 01, 2007

Generics=Channel Strife?

Will generics be the next battleground between branded drug makers and their wholesalers?

Pay attention to Pfizer’s latest victory against generic Lipitor in Denmark. Here’s the summary:

“Pfizer Inc., the world's largest drugmaker, said Friday a court in Denmark blocked the sale of a generic version of the company's best-selling drug, the cholesterol-reducer Lipitor. The company said the Bailiff's Court in Copenhagen issued a preliminary injunction against the country's largest drug wholesaler Nomeco AS, preventing it from selling a generic version of Lipitor made by Indian drugmaker Ranbaxy Laboratories Ltd.” (Full story: Pfizer gets court injunction against generic Lipitor wholesaler in Denmark)

Note that Pfizer’s victory is against Nomeco (the wholesaler), not Ranbaxy (the manufacturer).

Will this type of conflict spill over to the U.S.? Consider the following three points:

  1. The U.S. is moving toward reimportation legislation. There are bills before both the House and Senate. In Europe, wholesalers are big winners from importation because they absorb most of the price differences between countries. (See Importation Illusions.)Thus, importation legislation could be very good for the big wholesalers (AmerisourceBergen (NYSE:ABC), Cardinal Health (NYSE:CAH), and McKesson(NYSW:MCK)) as they would have the opportunity to become a legitimate conduit for imported products.
  2. Wholesalers generate more profits from generics than branded drugs. Generic drugs now subsidize the distribution of much more expensive branded pharmaceuticals. (First noted back in May Will unbundling crush pharmacy profits?)
  3. Intellectual property protection for pharmaceutical companies is under attack around the world. Keep an eye on a crucial case in India in which Novartis is defending its Gleevec patent. If they lose, then the world will have a new source of generics long before most U.S. patents expire. (See Novartis files suit against India ruling on drug patents.) The New England Journal of Medicine just published an article that argues in favor of India’s attempt to seize the patent. (See Taking TRIPS to India.)

Taken together, these three points suggest the potential for friction in manufacturer-wholesaler relationships due to the potent interaction of generics and importation legislation. I'll be curious to see if any manufacturers address this issue in the next round of wholesaler agreements.

Wednesday, February 21, 2007

Importation Illusions

Here's another reason to question the value of importation: it may not save any money! Pharmaceutical Manufacturing just published my op-ed outlining why manufacturers and consumers would bear most of the risks and costs of importation, but would get little of the supposed price savings.

Check it out here: Importation Illusions

(I realize that my article requires some understanding of drug distribution channels, so I'd welcome your ideas on how to get the message disseminated more broadly.)

The safety issue remains very significant. Yesterday's International Herald Tribune reports on an "epidemic of counterfeits" in Asia. (See A growing epidemic of fake medications in Asia.)

The scope and sophistication of the fakes is frightening. Here's the latest trend - fakes designed to act like (not just look like) real drugs. The latest fakes "contained drugs apparently chosen to fool patients into thinking the pills were working. Some had acetaminophen, which can temporarily lower malarial fevers but does not kill parasites. Some had chloroquine, an old and now nearly useless anti-malarial. One had a sulfa drug that in allergic people could cause a fatal rash. And some had a little real artemisinin — not enough to cure, but enough to produce a false positive on the common Fast Red dye test for the genuine article."

Apparently, counterfeiting is primarily an export business from China. Criminals and their families get sick, too. See my recent post Importing Chinese Counterfeits for more on the import risk for the US supply chain.

Now that the 2008 Presidential campaign has started (only 622 shopping days left until the election), I'll be very curious to see how the candidates address the realities of the House and Senate importation bills.

Friday, February 09, 2007

Importing Chinese Counterfeits

Today's Wall Street Journal has a fascinating peek into the world of counterfeit drugs in China. (See China Government Cited in China Probe.) The article states:

"For years, China's pharmacies and hospitals have been plagued by low-quality and fake medicines made by local drug companies. Just last fall, an antibiotic made by a pharmaceutical company in Anhui province sickened dozens of people across China and killed at least 10, according to China's state-run Xinhua news agency.

Blame often falls on small drug makers that the government says skirt laws to turn a profit. Now, the man who ran China's State Food and Drug Administration until he stepped down in 2005 is at the center of a widening corruption scandal. The State Council, the country's cabinet, alleges that Zheng Xiaoyu, the agency's former head, accepted bribes from drug companies and abused his power, according to Xinhua."

Scary stuff. It makes me appreciate the relatively secure drug supply chain that we enjoy in America. If you're like me, you'll also wonder why Congress wants to infect our system by creating new gateways for counterfeits with importation legislation.

I suppose we should all be grateful that Senator Dorgan's bill leaves China off the list of approved countries, right? His importation website mildly states: "The bill allows U.S.–licensed pharmacies and drug wholesalers to import FDA–approved medications from Canada, Europe, Australia, New Zealand, and Japan..."

But if you bother to read the actual text of the inaccurately named S.242 Pharmaceutical Market Access and Drug Safety Act of 2007, you'll discover that the list of permitted countries includes any "member country of the European Union."

I get really worried when I look at list of member states, especially those added in the EU's 2004 enlargement. So I'm left wondering: How hard would it be for a drug made in China to pass through Latvia or Slovenia on its way to the US? Let's face it -- probably not too hard at all.

Re-read my post from last November on a scheme that put fake drugs from India into the hands of US consumers. (Of Spammers and Senators). Then ask yourself: why are politicians endangering public health by opening up diversion channels for criminals?

Tuesday, January 30, 2007

The China Syndrome

On Friday, I pointed to China as a big growth opportunity for drug wholesalers. (See 3 Ways for Drug Wholesalers to Grow.) I didn’t have to wait long to be proven right.

On Monday, Alliance Boots announced a joint venture with Beijing Med-Pharm to acquire a 50 percent stake in Guangzhou Pharmaceuticals Corp., the third-largest pharmaceutical wholesaler in China.

In addition to its retail operations, Alliance Boots is one of the three largest drug wholesalers in Europe. Readers of this blog may recall that its UK division (Alliance Unichem) is working with Pfizer to consolidate UK product distribution. (See Pfizer's UK Deal: Change is Here!)

The reality of global drug distribution is getting closer, but the big US wholesalers – AmerisourceBergen Corp (NYSE:ABC), Cardinal Health Inc (NYSE:CAH), and McKesson Corp (NYSE:MCK) – remain on the sidelines. How much longer can they afford to wait?