The ability to compete globally is essential to success in the pharmaceutical industry. The current trend is to establish joint ventures, outsource various stages of the development and production of a single pharma product, and purchase or start an indigenous business in other countries. Successful companies have also moved beyond mere exploratory attendance at trade shows to gain familiarity with foreign markets and environments that are sometimes very different than their "home field." Executives sophisticated in handling cultural distinctions and regulatory nuances have a distinct advantage.  (See "Culture Clashes," page 76.)	

Understanding cultural differences is part of the secret to success; the other is knowing the company's legal rights, or more significant, its lack of rights in a particular foreign country. Companies need to be familiar with broad multilateral rules to be able to recognize those rights and make informed decisions about foreign initiatives. 	

This article examines the broad legal framework every pharma producer faces when developing, servicing, pursuing clinical evaluation, selling, or manufacturing components in foreign countries. A general understanding of the international legal regime that governs the actions of various countries can help pharma executives know what to anticipate and how to react.	

Because of their high R&D and other commercialization costs, pharma companies' most compelling international need is to maximize patent exclusivity-in years and in geographic scope. Time here is measured not only in how long and how well a foreign country provides patent protection but also in how easily and quickly a new product can be brought in to its market. In foreign pharma markets, getting it right the first time may be the difference between success and failure. Getting it wrong can mean competing against the company's own product in places no one thought possible, sooner than expected.				

The United States continues to be the leader in providing patent protection for innovative products, but the clear driving force today is the multilateral efforts under the auspices of the World Trade Organization (WTO) to promote and refine the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Although TRIPS was initiated through the Uruguay Round of multilateral trade negotiations and signed by the member-nation leaders on April 15, 1994, it continues to be the subject of much debate. Negotiations on various aspects of TRIPS continued during a second meeting in Doha, Qatar in 2001. A detailed analysis of the TRIPS agreement and the pharma industry is available at 		

www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm

The agreement requires all WTO members to create working intellectual property systems that not only establish basic legal definitions of intellectual property rights-such as patents, trademark registrations, and copyrights-but that also implement efficient registration procedures and effective enforcement regimes. TRIPS patent protection extends to products and processes and must last at least 20 years from the date the patent application was initially filed.	

The implementation of TRIPS is essential to the successful internationalization of the pharma industry. If anything, the agreement's negotiations and discussions have identified the relevant areas of weakness and controversy that need resolution both in the agreement and in the interests of developed versus developing countries. Developing country members have made progress meeting their TRIPS obligations but have yet to fully satisfy them.	

WTO developing country members-including Argentina, Brazil, Egypt, India, and Israel-were given a five-year grace period, until January 1, 2000, to implement most of their TRIPS obligations, but the success of such implementation remains under review and is subject to interpretation. The least-developed WTO members-primarily countries in Africa-were given an 11-year transition period, until January 1, 2006, but that deadline may be extended. Pharmaceutical products are subject to an additional waiver that allows for the delay of product patent protection by all developing countries until January 1, 2005. On June 27, 2002, the WTO TRIPS Council approved a decision extending the waiver for the least-developed countries until 2016.				

The countries able to benefit from the extension have two obligations. First, they had to allow patents to be filed, starting January 1, 1995, even though they are not required to decide about whether to grant any patent until January 1, 2005-commonly referred to as the "mailbox" provision. The process allows an early filing date so the application can satisfy a patenting criteria, such as "novelty." Second, should the country allow the product to be marketed during the transition period, it must give the patent applicant an exclusive marketing right for five years or until a patent decision is made, whichever period is shorter. Although there may yet be others, 13 WTO members have notified the TRIPS council that they have implemented a mailbox system. They include Argentina, Brazil, Cuba, Egypt, India, Kuwait, Morocco, Pakistan, Paraguay, Tunisia, Turkey, the United Arab Emirates, and Uruguay.	

India poses a particular problem. Opting for the permissible January 1, 2005 patent-protection deadline, the country has still failed to implement other TRIPS obligations, including protection for proprietary data of inventor companies and various enforcement and judicial remedies. The failure means that India's industrial property system is the default regulatory regime, which was initially structured to permit domestic companies to pirate the inventions of other countries. 	

As another example of particular problems, the TRIPS agreement allows member countries to provide for the use of patented inventions for R&D. Some countries take this notion further by allowing generics manufacturers to obtain marketing approval from government authorities without the patent holder's permission and before the patent protection expires. This practice is sometimes called the "regulatory exception" or "Bolar" provision. A Canadian law implementing the practice was upheld as consistent with the TRIPS agreement in a WTO dispute settlement panel report adopted by the WTO Dispute Settlement Body on April 7, 2000. But such provisions can be poorly implemented and counterproductive to future R&D.	

In Australia, for instance, a 1998 patent-term extension law permits "springboarding," which allows generic manufacturers to do all the required testing before the expiration for patents that were granted extensions under the 1998 law. Australia justified that Bolar provision on the grounds that the new extension for existing patents was a boon to the present patent holders, which necessitated a matching offset favorable to producers of generic products. Current patent holders complain that a springboarding compensation was not necessary considering the increasingly long delays in market approval resulting from the strict requirements for cost-effectiveness data and the difficulties of getting listed on 	

Australia's Pharmaceutical Benefits Scheme, the government-run prescription program. 	

Without immediate access to the market, patent holders that were granted extensions are unable to get sufficient returns under patent exclusivity to invest in future R&D. Australia's recent enactment of a law providing for five years of confidential data protection alleviates some of the concerns about springboarding, but it would be better 	

if it were extended to ten years and covered already-approved chemical entities.  For a review of other examples of specific problems with various countries patent regimes, see the US Trade Representative's "Special 301" Report on Intellectual Property Barriers, 		

One potential problem is that the TRIPS agreement permits compulsory licensing in certain situations subject to certain controls. In compulsory licensing, a government permits someone other than the patent holder to produce the patented product or process without the patent holder's consent. A compulsory license 				

cannot be given exclusively to a single licensee

must be granted primarily to supply the domestic market 

must pay the patent holder adequate remuneration. 

Some countries abuse compulsory licensing by making it overly broad and extending it to situations for which it never was intended. In Singapore and Vietnam, for instance, a compulsory license can be granted to sanction insufficient or "unreasonable" working of the patented invention, which is ripe for abuse and unnecessary in today's competitive atmosphere. Other countries, such as Bulgaria and Hungary, do not expressly recognize importation of a patented drug as evidence of "working the patent," which should be made an express part of any compulsory licensing law, as the Czech Republic recently did. 	

Domestic manufacturing should not be necessary to satisfy the requirement. Argentina allows compulsory licensees to export patented inventions when the license was granted because of a national emergency. Granting compulsory licenses to produce products for export likely violates the TRIPS requirements that compulsory licenses be limited to allow use predominantly in the domestic market. The issue has been at the forefront of recent TRIPS negotiations because it does hamstring those countries truly lacking in manufacturing capacity from importing cheaper generics from countries where pharmaceuticals are patented.	

Nevertheless, in light of the potential for abuse, US pharmaceutical companies should be careful in negotiating with foreign companies to ensure that they do not help establish the basis for a compulsory license. All negotiations with foreign competitors, suppliers, and others should be taken seriously, documented, and usually conducted with some input from legal counsel. Establishing a record of the reasonable commercial terms of the negotiation and what would qualify as adequate compensation may prove to be prescient if a compulsory license situation arises.	

If that line from the Eagles' song were revised to "you can spend all your time making money, or you can spend all your money wasting time," it would ring true for the pharma industry abroad. The time under patent protection is not measured solely in how long or even how well a country provides patent protection, but also in how easily and how quickly a new product can be brought to market in that country. 				

In other words, the period during which a drug can be sold under patent exclusivity is now a function of how long patent protection is afforded for a product and how soon the product can begin to enjoy such protection. That holds true now more than ever, because TRIPS specifies a 20-year patent protection from the patent filing, inclusive of the time it takes to get the drug to market. Although that issue was discussed during the Uruguay Round negotiations, the TRIPS agreement does not include a obligation to extend the patent term to account for commercialization delays, but some industrialized countries do compensate for the lost time in their patent laws.	

The best way for pharma companies to avoid spending time wasting money and instead, spend that time making money, is to take early stock of the foreign country's regulatory regime for drug approval. They should seek countries with transparent regulatory approval procedures coupled with predictable time frames and should use an experienced legal practitioner as their guide. Red flags to look for include	

strict data requirements, such as stability or cost-effectiveness data

quasi-governmental approval authorities such as public hospitals rather than established agencies

duplicative local testing and clinical trial requirements

repetitive and costly certification documentation.

Imported products may face additional hurdles in the form of quotas, discriminatory discretionary approvals, and even border testing requirements. For example, Vietnam still imposes import quotas on pharma products. Indonesia appears to discriminate in its registration process for imported medicines by approving only life-saving and small-volume drugs and products that cannot be produced domestically for technical reasons. Indonesia also requires foreign companies to maintain a local manufacturing facility to import finished products. And the European Union continues to insist on batch testing pharmaceuticals at the point of entry, increasing costs and causing marketing delays.				

Given the difficulty for individual companies to change approval schemes, forward-thinking pharmaceutical executives should draft contractual arrangements to account for regulatory hurdles. A contract for the foreign production of a product's intermediate stage in one country, for example, should be sufficiently flexible to accommodate approval delays that postpone finished product manufacture in another foreign market.	

Similarly, entering a foreign market through a joint-venture arrangement presents certain risks when regulatory approval is a prerequisite to success. Typically, joint ventures are not-nor are they meant to be-permanent relationships. Strategies, management interests, and business environments change over time, and the differing cultures of two or more countries can compound and accelerate those changes. Joint ventures are also often managed by both partners-a situation that is usually untenable as a long-term strategy. Joint ventures are more appropriately viewed as an interim step toward a business entity that is 100 percent controlled by one of the partners, or, in some cases, a third entity. It is critical for pharma companies to 	

make an effort to anticipate and predict the natural life of the venture, given the regulatory uncertainties

ensure that the agreement includes a well defined exit strategy.

The struggle toward approval may be dwarfed by foreign regulatory frameworks that control distribution and prices. A patent is useful only if the product can be sold at a price that compensates for the initial R&D and provides funds for future R&D. Now that high tariffs in most WTO countries have been addressed, successful foreign market access is keyed to price management regimes and prescription practices. (See "The Demise of Duties," page 78.)				

Those practices can vary considerably from country to country. Some of the more common are 	

Articles

Features

The ability to compete globally is essential to success in the pharmaceutical industry. The current trend is to establish joint ventures, outsource various stages of the development and production of a single pharma product, and purchase or start an indigenous business in other countries.

One World, Many Regulations

No greater challenge faces any writer than the empty page. To sully that beautiful white space with mere words can seem so arrogant, so pretentious, that one's urge is to leave it alone, in perfect blankness. To paraphrase an old writer's adage, just to begin may require lowering your standards-an act salvaged later only by careful editing.		

It has been my unique task and ultimate pleasure to face this empty page-and countless others-every month for nearly 17 years. Each time, my goal has been to fill this space with thoughts and ideas that resonate with the needs and interests of Pharmaceutical Executive readers. In that time, I've also written more than 150 cover stories, including Executive Profiles and special reports, to join all the other pages authored and edited by our outstanding staff. Now, at last, I face the last page in my stewardship of the magazine.	

As I relinquish the position of PE's Editor-in-Chief, I thank its owner, Advanstar Communications, for this opportunity to say farewell to you-the magazine's readers, advisors, managers, and staff. For a number of reasons, the time has come for me to leave PE in the hands of a new generation. It has been quite a ride-covering nearly three quarters of the magazine's life-since I inherited this position from former Editor Judee Shuler, now head of corporate communications at Eisai USA. She and a previous editor-in-chief, Suzanne Harvey, had already established a tradition of excellence in the editorial product. My aim, stated first in this space, was to "maintain and improve" upon that heritage.	

In time, with a succession of top-notch staff editors, I saw PE evolve into a not-to-be-ignored player in the pharma industry, one with a clear mission of leadership. Only when I was absolutely sure that we were fulfilling that mission did I inscribe it. For two years, we have published the mission, for all to see and judge, on our contacts page.	

Perhaps the ultimate example of the mission in action was our "Discovery!" series, which last year won the Oscar of business publishing, the Grand Neal. But the same directive has also driven all aspects of the magazine. This year, for "best single issue," PE is again in the running for the Neal, to be announced this month.	

Wishing the best of luck to the current PE team, I say farewell but not goodbye to all my friends who read this column. Thank you for all your help and support through these many years.	

So, why am I leaving? Partly because I've always aimed to end my tenure when the magazine had reached a pinnacle but still had plenty of growth potential-and long before I grew bored with it. All three conditions now apply.	

But be assured: My departure is a renewal, not a retirement. Truly, I wish to take on adventurous new assignments and roles that make sense in light of my interests and experience. 	

Another reason for leaving: I have never been able to seek other challenges while still engaged with the magazine. I can now explore opportunities that challenge me more, not less, than past endeavors. Yet, here, my final page as PE's chief editor is filled. And this hand, having written, will move on.	

Columns

No greater challenge faces any writer than the empty page. To sully that beautiful white space with mere words can seem so arrogant, so pretentious, that one's urge is to leave it alone, in perfect blankness. To paraphrase an old writer's adage, just to begin may require lowering your standards-an act salvaged later only by careful editing.

The Blank Page

All is quiet at the Drug Information Association's new headquarters, a short ride from the hubbub of Philadelphia. But inside, the association buzzes with change as it harnesses the expertise and energy of its members to improve healthcare around the world. Now approaching its 40th year, DIA is expanding both its educational programs and its global reach.		

DIA's executive team includes (l to r) Charles Depew, president, Bob Assenzo, executive director, and Irwin Martin, immediate past president and associate executive director.	

An association member since 1967, Executive Director Bob Assenzo confesses that his history is wrapped up with DIA's. He shares both accounts in an easygoing style, combining industry expertise gained from his former jobs in the regulatory departments of Novo Nordisk and Upjohn with the idealism of a director of a nonprofit organization. 	

DIA barely resembles the association that was incorporated in 1964. "We started out with 30 members, and now we have almost 1,000 times as many," says Assenzo. "The whole focus was on medical communications and figuring out how to best deliver up-to-date information to patients about the use and potential problems of pharmaceuticals. We formed because there was an interest in finding out how executives in other companies did their jobs. What their barriers and concerns were and whether they were the same as ours. And by and large, we found out that they were the same." (See "Membership Growth," page 36.)				

Today, DIA's 27,000 members come from every level of the pharma industry as well as from government and regulatory agencies, academic institutions, contract service organizations, and healthcare consultancies in 75 countries. DIA programs and services cover the gamut of drug development and marketing. But the association's purpose-the exchange of information to foster healthcare advances-remains the same.	

DIA's lifeblood is its volunteers-plus a small paid staff-and it survives because of their efforts to accomplish its mission of advancing members' careers, professions, and organizations. Volunteers' dedication to that goal, their ability to step outside of insular corporate thinking, and their grass-roots approach to tackling industry issues are what set DIA apart from commercial training companies. 	

Members often find that, as their careers mature, they end up volunteering to speak at or chair the same types of events they attended during the early part of their career. That's because, despite busy schedules, they find that membership has its privileges. 	

"When people share scientifically with friends and colleagues, they get a passion for DIA," says Assenzo. "Some people, like myself, volunteer because it's pay-back time. DIA helped my career, and now I can help other people. Others volunteer because they have something to say and they need a place to say it. DIA gives them that opportunity. Other people want visibility or recognition, and we can give them that, too, by offering them a stage to speak on. And the companies benefit. When I was at Upjohn, they supported my involvement because they knew, when I spoke on stage, people would say, 'Wow! Upjohn has a lot of good scientists. That's a company I'd like to work for.'"	

Companies may benefit, but DIA remains solidly committed to the individual. DIA's mantra of "meeting member needs" is especially notable, given an industry environment made faceless by megamergers in which long-standing employees have little job security. It gears its programs and services toward people within the healthcare industry, not just pharma. There are no corporate memberships or sponsorships, and individual dues are only $100, or 100 euros, annually. Those two factors create a neutral forum where all healthcare players-especially regulators-feel comfortable discussing healthcare issues and receiving training. 		

Assenzo says DIA's neutrality encourages the multidisciplinary approach necessary to make the organization work. "When we discuss controversial issues, we involve all parties. As such, DIA gives the industry the type of elasticity it won't find in pharma company board rooms-a forum where sides can challenge each other and they don't snap."	

Despite its age, DIA has yet to hit its stride. Various executives discuss the organization's current growing pains.				

Irwin Martin, immediate past president and associate executive director, a newly created position, says, "DIA started as a "mom and pop" shop. There are still a lot of residuals of how we used to do things and a 'this is how we've always done it' attitude." (See "From Past to Present," page 44.)	

That may change as DIA's structure becomes more complex. Specifically, it expects a proliferation of special interest area communities (SIACs), DIA's global grass-roots system responsible for identifying and prioritizing programming. (See "Special Interests," page 38.) 	

But for a group based on volunteerism, DIA is becoming too systemized, says Lou Morris, a former DIA president and past acting director and branch chief of FDA's Division of Drug Marketing, Advertising, and Communications, who now heads his own consultancy. "Volunteers today must be a member of a special interest group; there's an organization for those groups and a mission statement for each one. Overall, it is a much more complex method of creating workshops, and some of the oldtimers say it's getting to be too much like work and not as much fun."  	

DIA executives say members don't have to join a SIAC but that those groups are the major conduit for building an affiliation with the association.	

Martin says new committees are needed because "there's much work to do." That's especially true in areas outside of clinical development, which involves more than 45 percent of DIA's membership. 	

"In the past, we were strictly focused on the pharma industry and drugs, but that has changed because healthcare has changed," says Eleanor Perfetto, president-elect of DIA and managing consultant for the Weinberg Group, a scientific and regulatory consulting firm. "Now DIA is trying to cover the gamut and it is inevitable that groups such as device manufacturers, because of drug-device combinations, come under the DIA umbrella." 	

DIA's annual meeting is known as the event for those in research and development. It's an all-inclusive week-long buffet of poster sessions, networking dinners and functions, tutorials, and more than 350 sessions on topics ranging from advertising to validation. The 39th Annual Meeting, scheduled for June 15-19 in San Antonio, Texas, will feature 1,000 speakers and is expected to draw 9,000 people. Murray M. Lumpkin, MD, MSc, principal associate commissioner for FDA, will chair the event.				

 "When people ask if you're going to DIA, they're referring to the annual meeting," says Martin. "Even in the 1980s, our meeting was very important, though we had only 900 attendees. But it was still the place to be to get up to date on virtually anything related to pharmaceutical R&D."		

Carol Layer, administrative director and DIA's longest-term employee, says the meeting has become so popular that the organization must limit the number of exhibitors. Although that cuts into proceeds, she says, "keeping a reasonable balance between exhibits and attendees makes for a happier crowd." 	

The DIA office in Basel, Switzerland, holds an annual EuroMeeting with content similar to the US meeting, but regional experts present the sessions. Scheduled for March 5-7 in Rome, Italy, the meeting will have already occurred by the time this story goes to press. 	

Co-chairs for that event were Andrzej Czarnecki, worldwide pharmacovigilance and epidemiology expert for Eli Lilly, UK, and Jacques Mascaro of Johnson & Johnson pharmaceutical R&D, UK. Around 2,000 participants-double the number at last year's EuroMeeting in Barcelona, Spain-were scheduled to attend. 	

Long before pharma companies instituted "customer-centric" approaches, DIA was keenly aware of how its efforts helped patients. 		

"I'm old enough now to say this: DIA is going to help society," says Assenzo. "Our goal is to help people develop professionally so they will do a good job for their employers. Then companies will produce better drugs for patients. They will look at the right questions and not cut corners." 	

The DIA center for career and professional development (CC&PD), launched in June 2002, is charged with centralizing professional programs aimed at developing the organization's-and the healthcare industry's-future. Susan McLaughlin, worldwide director of CC&PD (formerly with Johnson & Johnson), says, to help employees remain competitive in the event of a pink slip, DIA must offer the training programs pharma companies have cut in the last four to five years. 	

"Training and education are critical to meeting our members' needs," says McLaughlin. "The center focuses on individuals and helps them shape their career in whatever path that might be. Down the road, DIA plans to start a mentoring program, so a member can come to us and say, 'This is what I've been doing. I'd like to move over here. What do I need to be able to do that?'" 	

Layer believes that, because DIA is about career and professional development, people should join for the most selfish of reasons. She says, "I don't focus on the altruistic aspect of volunteering. People should join because they want to do a better job, get promoted, increase their pool of knowledge, and be able, when their company downsizes, to move into another job. They should be mentored, networked, trained. They should know as much as they can about everything that's going on. We have 27,000 members, but only 1,000 are volunteers. The 26,000 members are not here for the warm fuzzies; they are here for the nuts and bolts, the content that we give away and that they buy."	

To jump-start college students' careers, CC&PD also maintains partnerships with several universities, including the Massachusetts College of Pharmacy and Health Sciences, the University of Southern California School of Pharmacy, and West Chester University in Pennsylvania.	

"We've started working with students because they are our future," says McLaughlin. "Universities are where new people are coming from, and they need to understand everything that they possibly can about the pharmaceutical industry."	

CC&PD also houses DIA's new e-learning programs, created to better accommodate its internationally dispersed membership as well as increased travel concerns. 	

"Everybody can grow, but we needed a spike of innovation to get us to the next tier," says Layer. "In the strangest way, September 11th was that spike, because so much of our information sharing-other than DIA journals-came through face-to-face meetings. What if we lost the opportunity to communicate to people in a live meeting? Would the association go away? No, but we would need to get content out in different ways."	

In October 2002, the organization launched its first digital medical communications program, which is certified by the Accreditation Council for Continuing Medical Education and the American Council on Pharmaceutical Education. It was so successful, says McLaughlin, that DIA is developing more e-learning modules, including a first-of-its-kind clinical investigator certification program.	

Like other associations, members maintain that much of the value of DIA meetings comes from networking. To transfer that interaction to web-based programs, the association is creating several "blended learning" initiatives, which consist of a face-to-face meeting and a follow-up or a continuation of that same subject online.	

McLaughlin says those programs hold the most promise for now because they provide a middle ground for executives, regardless of how web-savvy they may be: "We conducted a one-day, face-to-face HIPAA workshop, which was followed by two weeks of online web board access in which attendees could ask the instructor or other students questions. Participation was much higher than expected-85 percent of students participated in the follow-up. We are now looking at adding a workbook, CD, or video withthe live instruction."	

Efforts such as the International Conference on Harmonization and the common technical document are ushering in a decade in which drug development is a truly global process. 				

"Constituencies from around the world that were on the periphery of drug development are now becoming more actively involved because their governments are regulating more and want to interact with FDA and because the business of conducting clinical trials has spread to formerly fringe areas like Eastern Europe, Asia, and the Pacific Rim," says Michael Umen, DIA member and president of Michael Umen & Associates, a consultancy that helps generate drug approval applications for FDA submission. 	

With international offices in Basel and Tokyo, DIA already has a foot firmly planted oversees. Its executives believe that more offices may be established during the next five years as regional chapters begin to grow and prosper. In particular, DIA President Charles Depew, vice-president, worldwide regulatory affairs for GlaxoSmithKline, thinks membership in Japan will grow rapidly. Adding two new meetings there each year doesn't even keep up with demand. 	

"Even though you may develop a drug in one country, that doesn't mean it will be marketed in only one country," says Depew. "I was in a pharmacovigilance meeting in Japan, but the Japanese audience was interested in pharmacovigilance regulations outside of Japan. Industry people can go to DIA meetings to learn about regulations within their own country, but they can also learn about regulations involved in preparing their drugs for market elsewhere." 	

The executive committee, comprised of the current president, the president-elect, the immediate past-president, and the executive director, governs DIA's member-elected board of directors. 				

Executive committee volunteers-all unpaid except Assenzo-commit to a three-year term, while board members are elected to either a two- or a three-year term. Because the board only meets quarterly, allowing volunteers to meet the obligations of their day jobs, that time in office is necessary to affect change.	

"Each president takes a platform, kind of like Miss America," says Martin. "Nobody tells the president that they have to pick a pet project, but every president does." 	

Eleanor Perfetto, who takes the reins at the annual meeting in June, agrees that the three-year term is necessary because it "helps develop ideas for what you want to contribute, allows time to implement them, and ensures you'll still be around to follow up on that implementation."	

Perfetto is forming her plan now but says it will probably include staff education: "What will help maintain DIA's success is having a board of directors and staff who are well trained and prepared to handle the new roles, responsibilities, and budget that a large membership brings."	

Depew's focus on Europe in 2002 greatly expanded the organization's ability to work globally. By instituting operating systems and practices between the United States and international offices and by implementing standard operating procedures, DIA aligned the responsibilities and protocol for volunteer leadership throughout all offices. Having laid that groundwork, DIA was able to increase programming in Europe.	

Depew also revisited the strategic plan, opening it up for the first time to DIA staff below the senior management team level. The new plan, which includes an environmental statement that tracks trends in discovery, development, regulation, licensing, utilization, industry consolidation, evolving communications, and information management technologies, should help DIA keep its finger on the pulse of drug development and ensure that its programs are cutting edge. 	

Martin says his focus was building the new headquarters and formally establishing the DIA Foundation, which coordinates all the organization's charitable activities. The foundation's endowments support a wide range of training opportunities, from hosting meetings to arranging for regulatory agencies such as Australia's Therapeutic Goods Administration or the European Medicines Evaluation Agency to train other regulatory officials within their regions. 	

Executive Profile

All is quiet at the Drug Information Association's new headquarters, a short ride from the hubbub of Philadelphia. But inside, the association buzzes with change as it harnesses the expertise and energy of its members to improve healthcare around the world. Now approaching its 40th year, DIA is expanding both its educational programs and its global reach.

Membership Has Its Privileges

Consider the following real-world scenario:		

 Third-party auditors warn Schering-Plough (SP) of problems with product quality, including lack of quality control (QC) and high staff turnover.	

 SP's stock price reaches a high of $60 per share.	

 FDA completes an in-depth inspection of SP production facilities, identifying significant, repeated, and widespread QC violations dating to 1998. Several production lines are shut down and the Clarinex (desloratidine) launch is delayed.	

 SP announces FDA warnings and plans to increase quality staffing 30 percent by the end of 2001. Its stock trades at a low of $38.20 per share.	

 Public Citizen urges FDA to consider criminal charges against SP, alleging the possibility that SP was aware of QC problems while shipping defective inhalers (59 million units were recalled in the previous 15 months).	

 SP adds 500 people to its QC and production division to address FDA-identified deficiencies.	

 Clarinex receives FDA approval-a delay of almost 12 months because of SP's need to resolve manufacturing and quality issues. The overlap of patents between Clarinex and Claritin (loratidine) is ultimately cut in half, significantly affecting transition plans.	

 SP signs a consent decree with FDA, pays a $500 million fine, and agrees to stop manufacturing 73 products and to operate under tighter scrutiny through 2005. Its stock trades at $24.75 per share.	

 News of the impending precipitous drop in Claritin sales and the largely ineffective switchover to Clarinex drives SP's stock price down to $18 per share. 	

 Schering-Plough CEO announces plan to retire.	

SP's troubles serve as a cautionary tale for the industry. A quality-control department under fire can do immense damage to a company's reputation and shareholder value-and may even affect patient health if substandard products reach the market, new products are delayed, or products become unavailable. Such a department, if understaffed or poorly directed, can bring an entire pharma company to its knees.	

Although manufacturing design and production procedures have a sizable bearing on consistent product quality, the single most important factor in maintaining consistentency is the staff. Many companies have faced FDA scrutiny for quality issues in recent years, but others consistently maintain exceptional reputations with few or no major observations or "483" warning letters. Understanding what those companies are doing right is critical to staying on the leading edge of product quality and avoiding the pitfalls of sub-par performance.	

Although staffing decisions vary from company to company based on product complexity and diversity, executives can learn a great deal by studying QC department staffing parameters and tactics used by other top companies. Through in-depth interviews with executives at eight of the top ten pharma companies and leading medical device manufacturers, Best Practices uncovered cutting-edge strategies of successful quality departments. They include:	

roles and responsibilities that help companies stay ahead of QC issues 

staffing levels optimized to complete necessary tasks but keep costs in line

selection of the most experienced and capable personnel available

exceptional training, certification, and career path planning.

Current good manufacturing practices (GMPs) and FDA-approved processes are constantly changing, often resulting in regulations that lose clarity as they become more complex. Executives must carefully evaluate the company's mechanisms for staying ahead of regulatory changes, continuously review QC vulnerabilities compared with known or plausible deficiencies, and develop action plans to root out deviations. Therefore, the first step in properly staffing a QC organization involves arming employees with the knowledge they need to anticipate changes in the dynamic landscape, then reallocate roles and responsibilities to address the elements that have the greatest potential to compromise product quality. 	

Such systems must incorporate both internal and external perspectives to ensure maximum compliance. Internally, most companies rely on intranet postings and annual corporate quality meetings to disseminate best practices. A robust system to share best practices between manufacturing sites ensures replication of the most efficient and effective QC tactics and reduces variability-a key source of quality deficiencies. 	

Savvy companies also strive to identify and disseminate information about weak areas so that sites can check their own operations for similar deficiencies. Such companies have a culture that encourages employees to quickly identify and resolve QC problems across the board-rather than bury them to avoid putting a site "on report."	

It's also important to extend the QC division's scope beyond a company's own facilities. Successful QC functionaries collect information about manufacturing problems at other pharma companies. Key sources for such data are FDA releases (including inspection results, warning letters, or consent decrees), 	

F-D-C Reports publications (especially the Gold Sheet, which details QC reports for the pharma, biotech, and device industries), conference proceedings, and trade group interactions. (See "Suit the Action to the Information.")	

The corporate staff can then consolidate information into e-mails and send them out once or twice a day to all QC staff members throughout the company. The quality-control leaders at each site should analyze their operations to ensure that weaknesses found in other companies' plants do not exist within their own facilities. Sites can then correct any vulnerabilities identified within a reasonable period-say, 30 days-or include the proposed corrective measures in an action plan. Completing the circle, the corporate compliance group, in turn, should oversee the execution of all management action plans, ensuring that all sites systematically eliminate potential problems.		

Most high-performing companies tend to have a sizable contingent of QC personnel at corporate headquarters. That group consolidates many of the audit and oversight tasks, ensures consistency of practices from location to location, disseminates information gathered from external sources, and manages continuous improvement. Studies show that companies that maintain a top-notch 				

QC system year after year generally have most of their quality-control personnel at headquarters. (See "How They Stack Up," page 62.)	

Highly profitable companies with good quality-control reputations generally have one QC person for every four manufacturing personnel. Although staffing is a predominant cost driver of quality control, companies with only one QC person for every six or more manufacturing personnel must seriously evaluate their operation to ensure that they cover all pertinent QC roles and responsibilities.	

Another indicator of appropriate quality-control staffing is the ratio between the number of products produced at a facility and the number of QC personnel assigned there. Research shows that companies with good quality reputations generally produce fewer than two products (based on formulations) per quality department full-time equivalent (FTE) employees. One top company reported 500 site quality FTEs and a production of 300 different product formulations at its facilities, yielding an effective ratio of 1.7: 1. Again, staffing levels can be highly dependent on product complexity (large versus small molecule) and diversity (wide versus narrow range of products). To properly evaluate staffing levels, companies should make a detailed comparison of similarly tasked facilities or product lines.	

Overcoming staff shortfalls with the right personnel is an important challenge. Ideally, people brought into the QC organization should have either considerable pharma experience or exceptional quality-control experience from other industries. The "Experience Counts" chart (below) can help companies evaluate their QC staffs, based on their professional background.		

Companies with exceptional quality-control reputations have a relatively even spread of employees with experience across the four different bands. Those that have a high percentage of staff with less than five years experience must provide considerable training and oversight to overcome that situation. That might include more floor supervisors leading junior personnel, added training hours, and reduced responsibilities until such employees are further up the learning curve. A low percentage of employees with more than 20 years of experience may indicate that the company faces career path and retention issues, requiring more attention and incentives to keep experienced workers motivated. 	

In hiring new QC personnel, companies also must consider employees' educational backgrounds. "Background Check By Profession" (page 66) shows the considerable variety of academic disciplines represented in companies' QC divisions.	

Best practice companies generally find an ideal candidate, then try to replicate that candidate in each of their new hires. That tends to create a high concentration of individuals in one or more disciplines. Several reputable companies report a high number of employees with chemistry degrees, and one has found considerable success through a significant staff of engineers. 	

Depth of education is another important parameter in evaluating new hires. "Background Check by Degree" (page 66) shows the wide range of educational levels among pharma companies' QC staffs. Although individuals have different needs, companies with a significant percentage of degreed employees should have a training program that builds on such education. Jobs and activities for this group typically include more creativity, flexibility, and growth potential. 	

Several companies take a different approach, keeping staff costs in check by employing a significant number of QC personnel (up to 33 percent) without college degrees. Such a staff should have training programs more rooted in basic science and standardized job assignments until employee experience grows and they prove their capabilities. QC managers must regularly review, update, and follow employees' development to encourage them to gain the proper skills and maximize their value to the company.	

At one pharma company, the systematic use of a personal development plan program helps QC employees move in a career direction that suits their individual experiences, skills, and ambitions. Frank discussions between managers and employees help both parties plan for the future by creating succession plans for the QC function and determining the best methods for training employees. Personal development plans, prepared for each employee, should include the following:				

 Managers and employees discuss the employee's current skills and abilities.	

Employees and managers work to define long-term skills goals for the employee and, if possible, targets for advancement within the company.	

 Managers discuss the skill sets necessary for each quality control area. To visualize these, imagine a graphic matrix. Down the vertical axis are the skills necessary for employees in the quality-control function. Along the top of the horizontal axis are the six QC employee levels from entry level to senior vice-president. In the various cells of the matrix are details on what aspects of a given skill are needed at each level. Thus, a quality-control engineer's matrix would emphasize strong statistical skills, process excellence knowledge, and analytical and communication abilities. As the position level increases, technical skills become less important and the need for communication and interpersonal skills becomes greater.	

 Managers and employees should discuss how the employee will develop the skills necessary for advancement. That may include internal and external courses, rotations within the current division and function, and rotations to outside divisions and functions.		

That kind of extensive career planning can have a significant bearing on how well companies retain their quality-control employees. High turnover should be a red alert signaling a system that requires immediate attention. Beyond a development plan, other retention tactics include tying QC success to compensation, expanding responsibilities and accountability to motivate employees, and staying on the leading edge in QC certification and systems to create a sense of pride in the company.				

Most employees respond positively to an objective compensation system that rewards them for maintaining high standards. Top companies recognize that tensions may exist between a company's desire to hold employees accountable for performance and the realization that many factors are outside of individuals' control. The companies address that challenge by aligning employee compensation with metrics and performance goals that their behavior affects directly. Therefore, it is important to balance individual and company goal achievement measurements when tying employee compensation to performance metrics.          	

One top company measures the individual performance of QC employees in five areas: organizational development, financial, product improvement, regulatory compliance, and new product development. At the onset, the company sets individual performance standards based on each person's job description. Individuals fall into one of four quartiles in performance, ranging from "needs development" to "superior." The supervisor reviews the employee's performance, then the overall rating translates into the merit portion of any annual salary increase. A superior rating, for instance, might translate into a 6.5 percent merit increase.	

The system also integrates flexibility for changing priorities during the course of the year. "My performance and merit increase is based on my ability to meet the goals from the beginning of the year," explains an executive with the company. "That's how 90 percent of it works." 	

If a critical project comes along and resources need to be shifted, success on the unplanned yet key project can earn a superior rating as well. "That list of goals is not set in stone," he says. "You can still get a superior performance rating for something like that."		

Another company tracks individual performance metrics complimentary to overall corporate goals, then uses the measures to determine salary increases, bonuses, and stock option distributions for QC employees. It uses these programs to determine bonuses:	

Consider the following real-world scenario: Feb. 28-Apr. 14, 2000. Third-party auditors warn Schering-Plough (SP) of problems with product quality, including lack of quality control (QC) and high staff turnover. Dec. 20, 2000. SP's stock price reaches a high of $60 per share. Jan. 19, 2001. FDA completes an in-depth inspection of SP production facilities, identifying significant, repeated, and widespread QC violations dating to 1998. Several production lines are shut down and the Clarinex (desloratidine) launch is delayed.

The Right Staff

As the popularity of online training grows, many pharma companies are likely to implement learning management systems (LMS) that can manage the reams of data generated by training divisions in a regulated environment. 	

Each company has a different reason for moving its training online. It might want to	

avoid negative 483s-the reports FDA staffers file after inspections-which frequently focus on software testing and poor employee training

make it part of an overall productivity improvement initiative. 

This article demonstrates that online learning systems are uniquely suited to the needs of pharma companies and that they can do much more than manage content. Yet there are important differences among them, and the features that are most useful depend on a company's business and training needs.	

An enterprise learning management system is a specialized database application that supports the processes and record-keeping activities of a company's various training organizations. Many LMSs focus on specific needs; others serve as unifying applications for a company's diverse learning activities. They manage student information, track training assignments, allow access to web-based e-learning content, provide resources for instructors, control enrollment, and serve as a repository of historical data. (See "It's All Inside," page 88.)				

In pharma research, manufacturing, and distribution companies, a comprehensive LMS becomes an important part of the compliance process, keeps the field sales force up-to-date wherever they are, and helps build branding relationships with suppliers, healthcare providers, and the public. 	

In most pharma companies, learning management needs fall into five camps: personal/career development, sales training, operational training, safety training, and compliance. Although all are important to a company's overall mission, compliance training has a significant impact on the company's operations. Unlike development and sales training, compliance training is directly tied to a company's risk management programs. And, although other training areas are now coming under FDA scrutiny, supervisors in those arenas aren't likely to be cited in a 483.				

Some systemic training management problems have resulted in high-profile fines, plant shutdowns, and layoffs. Earlier this year, Schering-Plough was fined $500 million for violating good manufacturing practice (GMP) standards at facilities in New Jersey and Puerto Rico, where 13 FDA inspections found inadequate training of manufacturing and supervisory personnel. And in 1997, Centeon (now Aventis Behring) a blood products manufacturer, was placed under an FDA consent decree that prohibited the company from distributing products across state lines. Among other violations, FDA noted Centeon's inability to ensure that sufficient numbers of trained staff were on duty.	

In response to the demand for compliance tools, many pharma companies have invested in online learning systems. "E-learning has been adopted most quickly in the high-tech, financial services, consulting, and pharmaceutical industries," says Clark Aldrich, an independent analyst and columnist who formerly headed Gartner's e-learning research group. "Compliance was one of the first reasons for developing learning management systems, and the original LMS companies did a rigorous job of tracking and reporting. Recent laws such as FDA's 21 CFR Part 11, which concerns the security of electronic documents  and the Health Insurance Portability and Accountability Act (HIPAA), have re-emphasized the importance of auditability and the value that e-learning can have in automating the incredibly time-consuming tracking and validation process."	

According to FDA, LMSs are "quality systems" and, as such, are usually scrutinized at audit time. Many pharma companies have been stung by auditors because of poorly managed or non-auditable training records. A learning platform provides a framework to help keep the quality of records high and to automate the process of collecting and storing training data. Those applications are also a powerful tool for one of the most difficult tasks in regulatory compliance: management of change-specifically, handling revisions to standard operating procedure (SOP) training documents.	

For the most part, some type of document-SOP, manufacturing instruction, or building instruction-delivers regulated training. Almost anyone involved in training for GMPs knows those documents tend to change regularly. Revisions of documents used for operations send managers scrambling to find out whether training is necessary and, if so, who needs to receive it. Even if training isn't required, the workers affected by that procedural change must often acknowledge that they have read and understood the revisions. That is where a robust learning system can be invaluable, because it automatically assigns retraining to affected staff and its archive preserves records and notifications of that training.	

An LMS is also an important tool in companies' constant battle to keep sales reps well trained and up-to-date on the latest product news. Sales forces, with their traditionally high turnover and geographic distribution, are naturals for leveraging an online system's ability to assign needs to employees and deliver 				

e-learning to meet many of those needs. Saving the travel costs incurred by gathering the sales force at headquarters for training often offsets the upfront costs of licensing the software. 	

An LMS can provide a remote connection to sales reps, alerting them to changes in product specifications or new competitive information. Those systems also help pharma companies quickly and accurately identify the appropriate sales staff when they change a therapy's interaction or formulation data and deliver training to them wherever they are over the internet. 	

That ability is even more important now that FDA is scrutinizing sales staff as part of the overall quality chain. Sales people routinely discuss with physicians how medicines work and describe the differentiators between products, so they need to be apprised quickly of manufacturers' changes. Inaccurate or outdated information related by a sales person could lead to prescription errors-a contingency with which FDA is increasingly concerned. 	

Now more than ever, pharma uses online learning systems to interface with the public. Most companies offer websites on which caregivers and the public can read about their products or find educational resources. Imagine taking that idea one step further by using an LMS to help manage web-based physician education programs. Although most companies may not yet embrace that application, some, including the medical-device companies Guidant and Zimmer and the opthalmology specialty company Alcon, have begun programs. 				

Companies can use e-learning systems to manage continuing education, because a company's own clinicians use it, and most enterprise learning applications allow users to distinguish between students inside and outside the firewall. The LMS can also be used to develop and manage supplier and service qualifications and other training. Companies could even set up e-mail alerts notifying external students of product changes. Used that way, an LMS automates a framework to manage training-related information and serves the entire operation-from supplier to manufacturer to distributor, then from seller to caregiver, and, ultimately, to the customer.	

How can a company decide which LMS is best? There are many applications on the market, but they vary widely in design and scope. Some only manage e-learning (often called learning content management systems, or LCMS); some manage compliance training, and some focus more on self-directed or competency-based initiatives. For pharma and medical device manufacturing, there are three key issues: scalability, comprehensiveness, and validation. 				

 This is a broad measure of how well a software application can shift up from small scale-a low number of users, a small amount of managed data, a simplistic hardware architecture-to a system capable of managing a large, complex enterprise, without slowing down. If a company plans to implement a learning system at one manufacturing facility that has a relatively small head count, scalability is not critical. 	

But if it intends to roll out the system to tens of thousands of employees in geographically disparate areas where different languages are spoken, scalability is a top priority. In that case, the LMS must meet diverse business requirements and international privacy standards and comply with both US and non-US regulators. 	

On the technical side, companies that select an application that meets functional requirements 100 percent but is built on a shaky or underpowered architecture do so at their peril. If employees need to connect from home or over telephone lines, applications with minimal client-side software-with no programs or code downloaded to the local computer-are vastly preferable. That is especially true of organizations that don't want to spend time configuring and updating work stations. 	

Another important element of scalability is the ability to integrate with other software systems. Integrating the LMS with a human resources system automatically drives the entry of students into the training system and manages other student data such as job positions and locations. The system can also be integrated with financial management and other applications, such as document management systems-to automate the revision training process-and with workstation security systems to ensure that operators are trained to handle the latestprocedures.	

 Many selection processes ensure that basic functions are covered without weighing the company's unique needs. A system that concentrates heavily on web-based e-learning at the expense of instructor-led classroom training is giving short shrift to the management of that type of training, which constitutes between 60 and 80 percent of the training at a typical pharma company. 	

Many companies choose visually appealing products that perform the basic LMS functions well, only to discover that the system can't perform when expanded to all of the company's training communities-a comprehensiveness as well as scalability problem. A large, diverse organization must meet the needs of as many learning communities-which often have their own language and business practices-as possible. That way, a company can leverage the unifying nature of an LMS instead of buying yet another system that must be integrated into the network.	

 Software's capacity for validation-through exhaustive testing designed to prove that it does what it says it can do-is, of course, another major driver. Most pharma and medical device companies' quality assurance staff will insist that it's the main driver because choosing an inappropriate system can be wasteful and even risky. Any learning system used in an FDA-regulated environment must have an audit trail for GxP data-industry shorthand for good manufacturing, clinical, and laboratory practices. It also must provide sufficient system security and, if a company uses electronic records, electronic signature functionality that complies with 21 CFR Part 11. 	

A list of the ten most frequent GMP violations, released by FDA auditors at a recent conference, identified "lack of process and computer validation" as the number-one offense and named "inadequate employee training" as another. 	

Although an LMS vendor cannot perform the validation itself, it can certainly help with documentation and references of customers that have been validated before. Vendors should be straightforward about how they manage potential validation risks based on defects discovered in a product. They should be willing to support onsite vendor audits and should be knowledgeable about validation issues. A company's quality assurance staff should sit down with the vendor early in the evaluation process to gauge their own level of comfort with the vendor's knowledge in that area. 	

Finally, companies should be wary of promises of future functionality. It's not uncommon for a vendor to promise to add new features and functions to meet a customer's requirements. That isn't necessarily a bad thing, as long as the vendor really knows what it will develop and can describe it in detail. Companies should be especially vigilant about promises that relate to the auditability of the application. Implementing functionality to meet FDA requirements is complex; software vendors must understand the relevant regulations, preferably through experience with more than one customer. 	

Most pharma companies have their own interpretations of how to meet FDA requirements. An application that was built to meet one company's regulatory interpretation can result in an application that calculates, stores, and displays data in a way that is unique to that company and can't readily be applied to others.	

Usually the first thing companies discover in the market for enterprise learning software is that nobody makes a system that completely meets their needs. In fact, in the commercial off-the-shelf software (COTS) development world, it's considered a success to meet 75 percent of a customer's requirements without customization. 				

So, why shouldn't a company's IT staff or a consultant build one from scratch? The economics of design, delivery, and maintenance make it unwise to build an LMS from the ground up. In addition, it takes software architects, functional designers, and software engineers to create an application and many designers and engineers to maintain and update it, especially with FDA continually releasing guidances that make incremental, but critical, changes to the interpretation of regulations. In addition to software maintenance, COTS products incorporate technological and functional improvements with each new release-often from customer feedback, industry trends, and instructional advances. 	

Furthermore, it takes much more time to design and build custom learning systems than it takes to install and integrate COTS applications. FDA tightened requirements on all applications that are used as part of a company's quality system, and there's a considerable difference between understanding validation test scripts for unfamiliar functions and validating a system that has already been tested at other companies.	

Nevertheless, the "build versus buy" debate is not a black-and-white issue. There are many circumstances in which companies might choose to build their own LMS solution. Stringent security concerns, unique workflow issues, non-standard technology limits, and access to software engineers all drive companies to build in-house. The key is weighing the costs, both current and ongoing, against the compromises a company must make to develop the best tool for its needs. 	

As the popularity of online training grows, many pharma companies are likely to implement learning management systems (LMS) that can manage the reams of data generated by training divisions in a regulated environment.

The Virtues of Virtual Training

For the pharma industry, the year 2002 brought unprecedented competition, pricing pressures, public scrutiny, and ever-increasing regulation, all exacerbated by a weak economy. (See "Defining Events," pages 50-56.) Although a few companies forged new partnerships and produced life-saving treatments, many more struggled to meet the industry's challenges. And no road map exists to guide them through today's continuing market pressures or to help them anticipate tomorrow's challenges. 	

But a new Ernst and Young report, "Partners with Vision," called on some of the world's experts in the pharmaceutical, health, and related industries to explore how pharma might yet reach the golden age of medicine. This article summarizes the result of those discussions. Although their collective voices propose no single path, their leadership offers some guideposts to increased innovation, productivity, and accountability and may serve as a catalyst to foster better relationships both inside and outside the industry.	

In the next ten years, say the experts, success will come to those companies that build on past achievements and create a strong vision of the future healthcare marketplace, while dealing with two key dilemmas:				

 Pharma costs are increasing while stockholders' investments are decreasing. Industry analysts and investors meticulously monitor how companies respond to those conflicting forces. Pfizer CEO Henry McKinnell predicts that "unsuccessful companies will be absorbed by those that have mastered the 'productivity paradox' by yielding return on R&D investment." At least two companies have successfully managed that paradox:	

Novartis. To forge stronger relationships with top scientific and academic communities, the company moved its headquarters from Cambridge, England to Cambridge, Massachusetts. 

GlaxoSmithKline. To create a more entrepreneurial environment, GSK is breaking up its R&D units and creating six independent Centers of Excellence for Drug Discovery. That new R&D structure provides the flexibility needed to better coordinate research, allocate funding, and improve pre-clinical research and clinical development productivity. GSK also announced that it has doubled its new chemical entities (NCEs) in clinical trials.

The "Partners with Vision" report explains why those two leadership components are critical to the industry's survival and argues that pharma companies can take the industry to the next stage, if they address four key areas:	

global regulatory and legislative risk management

In the wake of recent court settlements stemming from drug promotion and selling misconduct and ImClone's FDA missteps, mitigating and managing legislative and regulatory risk have become a primary industry concern.	

To meet the demands of a global economy, pharma companies must comply with many countries' high regulatory standards. Global laws have become so cumbersome, however, that niche industries have emerged to support the many different national regulatory processes.	

Despite those hurdles, pharma companies have developed expertise in navigating complex regulatory environments to get their products to market. They can do so by aligning their vision with that of each government and the public it represents. 	

In response to the question, "What are the prospects for a full partnership between governments and the industry?," leaders in the following countries outlined how partnerships with government will lead to better knowledge of public health issues, streamlined drug approval processes, greater access to essential medicines, acceleration of R&D, and increased capital from joint funding for research. 	

United Kingdom. Alice Pomponio of the British Consulate points out that the UK's Pharmaceutical Industry Competitiveness Task Force has brought together the expertise and experience of industry leaders with policy makers to optimize and strengthen the competitiveness of the UK business environment for innovative pharma companies.  	

Canada. Health officials forged a deal with Bayer AG to produce Cipro (ciprofloxacin), preserving the manufacturer's patent rights while obtaining the medicines needed for stockpiling against the threat of bioterrorism.	

United States. Innovative private/public partnerships have emerged in response to tight state healthcare budgets. In exchange for guaranteed savings to state Medicaid programs, pharma companies are being given preferred status on state formularies. Despite those successful efforts, some industry advocates fear that such collaboration will shift power to regulators by virtue of government's purchasing power and inevitably to price controls, thereby reducing the capital needed for future R&D.	

For the pharma industry, the year 2002 brought unprecedented competition, pricing pressures, public scrutiny, and ever-increasing regulation, all exacerbated by a weak economy. (See "Defining Events," pages 50-56.) Although a few companies forged new partnerships and produced life-saving treatments, many more struggled to meet the industry's challenges. And no road map exists to guide them through today's continuing market pressures or to help them anticipate tomorrow's challenges.

Pharmaceutical Executive-03-01-2003

One World, Many Regulations

The Blank Page

Membership Has Its Privileges

The Right Staff

The Virtues of Virtual Training

Table of Contents

Executive Prophesies Vision for the Future