A magazine ad for Boniva, fronted by actor Sally Field, generated the DDMAC (now the Office of Prescription Drug Promotion, or OPDP) Untitled Letter last year due to following phrase: “After one year on Boniva, 9 out of 10 women stopped and reversed their bone loss.” That didn’t jibe with the scientific data, DDMAC said in the letter, before requesting that all ads containing the phrase be removed from the campaign.

Genentech went a step further. In September of last year, the company began running corrective magazine ads addressing the overstated claim. The corrective ad states that the violative ad “may have given you the wrong impression.” It goes on to state that “Boniva has not been proven to stop and reverse bone loss in 9 out of 10 women and is not a cure for postmenopausal osteoporosis.” The corrective ads will run though April 2012.

Unlike their mild-mannered, Untitled Letter cousins, Warning Letters are considered more severe, and they typically mandate corrective ads to clear up any overstated claims or minimized risk information. Given that Genentech received the former communique and not the latter, it’s notable that the company chose to run corrective ads without a mandate.

After speaking with DDMAC about the Untitled Letter, Genentech worked with the agency to create and then “voluntarily” launch the corrective ads last September, according to Chris Vancheri, director, public affairs, at Genentech.

In a statement, Genentech said that in addition to the corrective advertisements – which are running in several women’s magazines, including Weight Watchers and this month’s WebMD the Magazine – “our clinical specialists have reached out to health care providers” to inform them about the corrective ads, which intend to “clarify the benefits and risks of Boniva in women suffering from post-menopausal osteoporosis.”

Sally Field was the face of Boniva beginning in 2006, but Vancheri says Field is “no longer engaged” on the campaign. GlaxoSmithKline signed a co-promotion deal with Roche on Boniva in 2001, but the companies broke the partnership in 2010.

In 2011, the patient’s clout as a stakeholder was firmly established, as reflected in several industry conferences. What’s next for the patient in 2012?

In 2011, many healthcare organizations came around to the idea that patients should be included in discussions that had customarily taken place about them, but without their direct participation. This shift was evident at several healthcare conferences last year, and bodes well for 2012 as a year when further overtures – and partnerships – will be formed with and between patients.

Health2.0

The Health2.0 conference in San Francisco brought a deluge of innovation and shiny, new healthcare applications. Data plus IT and innovation represent the future of healthcare, and individual patients are a critical component of this equation (not just their data). This was a key theme of the Health2.0 conference. “Patient stories” have often been highlighted at conferences, and used as bookends to infuse a dose of reality to educational sessions.  What impressed me about the Health2.0 conference was the inclusion of patients and caregivers in the conversations, allowing for bi-directional exchange. Patients2.0, an offshoot of Health2.0, is a movement that aims to revolutionize healthcare delivery around the patients. The goal is to leverage the Health2.0 phenomenon and develop a hub for patients to exchange experiences through peer-to-peer networks, to obtain information, and most importantly, to have a collective voice in healthcare decision-making. By sharing stories, co-creating health data, and aggregating issues across the healthcare spectrum, the voices of Patients2.0 are empowered to be part of the larger conversation, and to exert influence on the health system by shaping future policy. Patients are the new healthcare disruption that can help transform the landscape, and using forums such as Health2.0 to involve them every step of the way is truly ahead of the curve.

Epatient Connections

The key theme at the Epatient Connections, held in Philadelphia, was that “Healthcare is Social.” Physician, medical and patient communities are forming connections through various social media channels, but there are a still a few less progressive entities a step behind as they figure out how to navigate uncharted regulatory waters. As connections are made, patients are becoming further engaged in their care as they learn from what others are doing. The key is to take those connections one-step further and bridge the various pockets of connection. There needs to be further inter-connectivity between patient voices, scientific publications, medical results and records, and medical education geared towards healthcare professionals, and these need to set the stage for a longitudinal data set. Patient engagement tools that were showcased included everything from health management tools to game-ification that integrated feedback mechanisms and incentives to an Internet enabled robotic telepresence, allowing immobile patients to interact with their healthcare community.

SXSH Unconference

The SXSH Unconference also took place in Philadelphia (Sharing, Exchanging, Social Health). Todd Park, CTO, US Department of Health & Human Services opened up the conference with an introduction to the Data Liberation initiative: New Incentives+ Information Liberation= Rocket Fuel for Innovation. Medicare, Medicaid, and the Veteran’s Administration represent the largest repository of public health data in the world. Patient data liquidity and information about the public health, stripped of personal identification, is being made available so that innovators can use it to create health-maximizing options.

2012

2011 was a year where a foundation for the “patient voice” was established as a critical component of the healthcare system. 2012 will be an even more important year, as healthcare organizations empower more patients by personalizing communications for individual patients. Patients are often overwhelmed with the amount of information they must retain to successfully manage their health. How will healthcare organizations come together to simplify navigation of the healthcare system? How will different healthcare systems, records and applications that serve different purposes connect with one another to prevent redundancy? How will patient stories be further synthesized and culminated into “patient issues” that a roundtable of healthcare sectors can further troubleshoot at future conferences? If 2011 was the year of dipping toes in the waters of “patient engagement” …2012 should be the year of swimming alongside others towards a unified goal—a year of patient engagement through an open network of inter-connectivity.

Sarah Krüg is CEO/executive director of CANCER101, a patient outreach and advocacy organization. She is also president-elect of The Society for Participatory Medicine.

This year’s list has attracted criticism for its inclusion of controversial characters such as Paul Ruddock — whose hedge fund management company Landsdowne Associates made £100 million ($156 million) betting on the collapse of Northern Rock — and Gerald Ronson, who was sent to jail for six months and fined £5 million in 1990 for his part in the Guinness share-trading scandal (but has since redeemed himself with much philanthropic fundraising). There was also a measure of hostile reaction to the knighting of Paul Bazalgette, a TV executive responsible for bringing the egregious Big Brother to British TV screens.

Still, none of this is bad for pharma’s reputation — in such company Witty really does seem something of the ‘knight in shining armour’, rewarded as he is for services to the economy rather than donating vast amounts to the Conservative Party (which some would suggest is the reason for Ruddock’s recognition). And Witty is not the only pharma industry representative to be honored. Richard Barker, former Director-General of the Association of the British Pharmaceutical Industry, was also handed an OBE (Order of the British Empire).

The decentralized approach to product commercialization, which puts global headquarters in the role of “coach for the affiliate,” represents a corporate rethinking, although the pendulum tends to swing from centralized to decentralized (and back) over time, said S. Michael Harrill, Lilly’s global brand director, neuroscience, during a presentation yesterday. “We’re now in decentralized mode, which is a big difference from five years ago,” said Harrill.

As such, global headquarters and affiliates do their own market research prior to launch; the former does not necessarily guide the latter. Prior to a global launch, companies are understandably “working with incomplete data,” although Harrill says Lilly is “investing heavily in market research, and will do even more” in the future. But it’s important for affiliates to conduct their own research, rather than cribbing exclusively from headquarters’ intel, “so it’s not supposition on top of supposition,” said Harrill. Allowing affiliates a degree of independence lets them adapt to the situation more quickly, he said.

In pre-launch, Harrill emphasized the importance of ‘PRA,’ or pricing, reimbursement and access issues, and anticipating payers’ needs. “Ten years ago, we were creating a pricing value and access notebook too late, around phase 3, but now that happens much earlier,” he said. Other pre-launch activities include an understanding of the patient journey – a “new moniker” at Lilly – as well as key player segmentation, competitive activities assessment, tracking and influencing environmental issues (SWOT analyses, for example), creation of HCP and patient education materials and brand certification training.

In the peri-launch phase, Harrill said key roles include tracking and influencing an affiliate’s operating expenses, coordinating global manufacturing supplies, insuring PR and patient advocacy plans are in place, conducting launch preparedness assessments, and updating the global brand strategy.

In the post-launch phase, the old rule of thumb – at eight months, it’s possible to get a pretty good idea of a product’s trajectory – isn’t appropriate anymore, said Harrill. “Delays in access, REMS, and other issues have lengthened the front end of uptake…there are often six or 12-month delays in access.” Building on that thought, Harrill said the sales rep to PRA personnel ratio is “out of balance.” He cited the fact that Lilly has only four PRA managers in Italy, in neuroscience. “When you think about the number of accounts in Italy, that’s mind-boggling,” said Harrill. In Italy, marketers could end up “sitting there twiddling their thumbs while four PRAs get access in the 12 provinces you’re counting on.” Harrill also acknowledged rising commercialization costs and shorter net exclusivity periods, and faster uptake of generic products upon expiry, to underscore the need for organizations to “look for what the payer wants, early.”

Harrill’s comments were delivered at CBI’s 2^nd Annual Commercialization and Market Access Congress, in Philadelphia, on December 6. CBI is a subsidiary of Advanstar, publisher of PharmExec.

Back in August, before there was any mainstream media coverage of the movement, Occupy Wall Street (OWS) cited Franklin Delano Roosevelt’s Economic Bill of Rights speech on one of its websites, which includes the “right to adequate medical care and the opportunity to achieve and enjoy good health.” To the pharmaceutical companies with headquarters in the tri-state area: why not send a few boxes of provisions to the demonstrators? Not prescription drugs, of course, but OTC products like Band-Aids, Neosporin and tampons (Johnson & Johnson), and Advil, Robitussin and ChapStick (Pfizer).

Pharmaceutical companies complain, rightly sometimes, that they aren’t duly recognized for the community service and philanthropic efforts they provide and support, outside of core business operations. Industry’s current reputation may be slightly “above Congress and tobacco,” as Pfizer CEO Ian Read recently put it, but that isn’t saying much. Pfizer headquarters is a subway ride away – without the need to change trains – from Zuccotti Park. Johnson & Johnson likes to talk about the clear social benefit its products have provided over the years, but here is a chance to bandage the cuts and scrapes of an active and visible community. It’s a PR play, but one that isn’t damaged by its transparency. Given J&J’s ongoing manufacturing difficulties, and Pfizer’s ongoing promotional missteps, both companies could use a reputational lift.

From an OWS perspective, companies like Pfizer and Johnson & Johnson represent a scientific vehicle fueled primarily by commercial interests, without seat belts or airbags; the humanistic objectives of most pharmaceutical scientists get left by the wayside. Executive compensation at top pharmas, in the context of plant closures in the U.S., is also a point of contention. Despite this perspective, a goodly portion of the demonstrators, not to mention their families and friends, have probably depended on medicines produced by one of these two companies, at one time or another. The question is, would OWS be willing to accept a gift of bandages, pain relievers, decongestants and other products from pharma, to aid in the struggle against the elements? My guess is that they would, and that they would be grateful. It wouldn’t hurt to ask. Perhaps the question can be put to the General Assembly, for a consensus vote.

Regardless of whether you believe access to adequate medical care is a right or a privilege, what would be lost by donating a few boxes of Dr. Scholl’s to OWS, Merck? The Congressional Budget Office’s October report on income growth (1979-2007) makes it more difficult for political pundits to continue saying they don’t understand what the OWS message is, or why these demonstrations are occurring (full CBO report here). Gifting medical supplies to protesters accomplishes PR goals, and it aids those demonstrators willing to stand and sleep outside for a cause they believe will help make America a stronger, more equitable place to live and work.

Pfizer, J&J, Merck and others, will you step up? Anyone own a subsidiary that makes hand warmers?

According to eligibility requirements on the CMMI website, the advisors program is seeking professionals employed by a “public health or healthcare facility, institution or department,” including, but not limited to, “physicians, nurses, allied health professionals, instructors and non-clinicians (i.e. health care executives, practice managers) with experience in the healthcare field.” Management experience is considered an asset, and the selection process will consider an individual’s “career achievements”; “pre-existing skill set (and it’s relevance to transforming the healthcare delivery system for Medicare, Medicaid, and CHIP beneficiaries)”; “quality of their proposed innovation project in their home organization or area;” and “their organization’s explicit commitment to their work.”

The key areas of focus for innovation advisors include healthcare economics and finance, population health, system analysis and operations research. As many as 200 individuals will be selected between now and 2012, with the first group of advisors beginning a “six-month intensive orientation and applied research period” beginning this December. CMMI notes that advisors will not become government employees, although an advisor’s home organization will receive a stipend. Advisors will be expected to commit up to 10 hours a week, which includes a mix of on-site, in-person meetings, as well as ongoing meetings conducted remotely.

Given that any changes to the Medicare and Medicaid systems would directly impact pharmaceutical companies, it may be wise for the C-suite to consider participating; the deadline for applications is November 15^th.

If there is one message that big pharma has applied consistently over the years, it is that drug development is very expensive. Big bucks and long-term investment in the institutional know-how and capacity built exclusively through private enterprise are what count in delivering new therapies to patients.  But like everything else in a dog-eared play book written in what might as well be the technological equivalent of the quill pen, that consensus is now being “goosed” — and from within the industry’s own ranks at that.

In a September 27 speech to the Indian pharma association that attracted little notice here in the US, GSK CEO Andrew Witty plucked some of the substance out of that linear defensive policy wall built by the industry over the past two decades, namely, that the high risk of compound failure leads inevitably to high costs and that this in turn justifies big margins on new launch therapies, across the board.  In his remarks, Witty literally turned the argument on its head, declaring that the industry-backed estimate of more than a billion dollars on average to bring a compound forward from discovery to market authorization was “unacceptable.”  The only “evidence”  it provides is for the perpetuation of a 25 year old model of commercialization, one that frames the debate around larger issues of pricing, IP  and access in a manner that serves the interest of neither the patient, society — or the industry.

What Witty was alluding too is the folly of a message that relates high costs and high prices to what is in essence the burden of low R&D productivity — and the honest way to call that is an “industry failure,”  which he did in his talk.  “We need to fail less, and deliver more,” he said, and directly linked success in restructuring the R&D enterprise to lower development costs in making the best new innovations more affordable, at all income levels, within and across markets.

As usual, Witty raises important and provocative issues that all stakeholders in health ought to take into account.  Just one that comes to mind:  If high prices that lower access are attributable to a flawed R&D development model, is there a readily applicable formula that industry can embrace in delivering better results at lower costs?

From an industry-wide perspective, Witty has accentuated the need for a consensus to promote those “lean management” business tools that can boost productivity and dramatically lower the cost of failure.  Yet to date almost all the evidence accumulated and backed by industry focuses on the inevitability of escalating commitments, whether it be the opportunity cost of sinking scarce funds into early discovery ventures, or the inability to predict with any certainty the response of payers to pricing post-launch.  Overall, the numbers paint a scenario of gloom:  a survey released by the consultant group KPMG last month finds that ROI from in-house investment in R&D among the 30 top drug makers is today half of what it was in 1990.

And while pressure for more affordable pricing is gaining momentum everywhere, due to a demographic and income transition in many emerging markets and the fiscal meltdown in mature countries, new costing commitments placed on the industry are rising too.  How many CEOs are really aware of the multi-million dollar price tag for post-marketing safety studies required by regulators over a time period that often extends beyond the life of the product’s patent?  Funding the demand for post marketing information about how well innovations work in practice is beginning to exceed what is spent to obtain a license to sell in the first place.   Or the endless, “write another check” implications of expanded access programs for yet to be approved drugs, where for ethical reasons there is no end point for giving drugs for free to patients with no other treatment options.

Hard data drives policy — it makes industry positioning credible.  Fresh arguments with verifiable metrics to show the industry actually has a strategy to make its own technology cheaper — and thus suitable for a global market of radically diverse price points — will be vital to the repositioning that Witty seeks.   In other words, the challenge is that while the problem is now defined by the industry itself as an industry responsibility, can industry deliver on the solution?

William Looney, Editor-in-Chief

Amidst yellow sandstone arches and California Mission Revival architecture, The Medicine 2.0 +Stanford Summit (otherwise known as the Fourth World Congress on Social Media and Web 2.0 in Health Medicine) set out on a three day journey to challenge its diverse audience to break down silos and expand beyond traditional boundaries. From a focus on research findings and scientific data to dialogue around the future of science, medicine and emerging technology, innovators and thought leaders congregated from around the globe at the state-of the-art Stanford venue, Li Ka Shing Center for Learning & Knowledge. Through the congress, Stanford extended an invitation for open scientific inquiries into the pursuit of teaching, learning, and research, in alignment with its motto. ¹

The energy in the room was contagious starting with the unique conference badges that featured personal QR codes (eliminating the need for business cards), lively twitter feed and building of a #med2 community (over 5,000 tweets!), to the theatrical presentations that conveyed unconventional solutions to healthcare issues. From theory to practice–patients, healthcare professionals, academics and executives discussed and debated concepts such as participatory medicine, patient self management, behavioral change, decision making, the quantified self, communities of practice, social networking, gamification, personalized healthcare, and innovation in medical education. There were so many interesting points made at Med2.0, but I’ve captured a few highlights below:

Abraham Verghese, MD eloquently walked us through the bedside ritual of examining the patient as a critical but threatened skill that is the foundation to the patient-physician relationship. He explained the potential of displacing the patient during the digital age and reliance on technology during the clinical encounter —with more emphasis placed on patient data, rather than the person being treated.

Jennifer Aaker, PhD delivered a brilliant keynote that demonstrated the impact of social media saving lives through storytelling, collaboration, and enabling the wider community to quickly act. The story began with 2 Indian men with AML in search of bone marrow matches and ended with 20,000 South Asians registering as a result of a powerful awareness and social media campaign. Attendees had the opportunity to have their cheeks swabbed and sign up for the Be The Match Registry during the break in the corridors.

The eclectic BJ Fogg, PhD shared his behavior change model which shows that three elements must converge at the same moment for a behavior to occur: B = MAT (Behavior = Motivation x Ability x Trigger).

Susannah Fox gave the closing keynote on the impact of “peer to peer healthcare” where patients are seeking and sharing health advice online. Roadblocks included pockets of offline patients, patients not motivated to engage in their healthcare, silo tools/communities, and lack of awareness of resources. Opportunities included leveraging the power of online caregivers, engagement prompted by life changing diagnoses/events, rise of mobile adoption, and emerging focus of technology that bridges silos and allows data flow. The beacons of change in these efforts include patient, clinician, and technology leaders.

There was a major focus on patient self management platforms in chronic diseases, the Quantified Self and use of digital devices to collect real-time quantifiable patient data, decision support tools to make informed choices, and gaming to change behavior by rewarding patients for meeting health related goals. With all the data being collected, the question is how do you give back the data to patients, synthesize, and set context in a way they can understand?

The use of technology as a catalyst in healthcare improvement was prevalent.  From the use of social media and mobile health tools by physicians to communicate and improve clinical workflow to the use of virtual community platforms by patients to share experiences, understand options and obtain social support–It was clear that patients and healthcare professionals are embracing the impact of technology—although not necessarily at the same pace. Patient online usage to share and obtain healthcare information is on the rise; however a research abstract (764) demonstrating physician attitudes towards social media for their own professional education and knowledge sharing showed that usage and intent to use is fairly low. Plagued with social media privacy concerns and associated risks, traditional modes of learning, and lack of clear guidance and policies—physician usage is growing at a snail’s pace in comparison.

There was a spotlight on the e-patients, of which 23 received scholarships to attend the conference. Each had a compelling story to tell regarding their personal but at times unfavorable experiences with the healthcare system and how they made informed medical decisions by becoming more empowered and engaged in their healthcare. These real life interactions crystallized key themes conveyed throughout the conference.

Larry Chu, MD was the skilled conductor of this colorful performance, which set the bar high for future Med2.0 conferences. We were each given the opportunity to challenge both established and new orthodoxies in healthcare, infuse innovation and creativity into potential solutions, and explore collaborations among the diverse Med2.0 community to make things happen!

Planning for the 2012 Med2.0 Congress is underway to be held September 15-16^th at Harvard Medical School. Stanford will also debut MedicineX in 2012 focused on the intersection of emerging technology and the future of medicine.

¹ Die Luft der Freiheit Weht-unofficial Stanford Motto, Ulrich von hutten, 16^th century

Sarah Krüg is executive director at Cancer101, a patient organization. She was previously Global Education Director in the Medical Education Group at Pfizer

Asked whether DTC ads on television should be retired, Read answered unequivocally – “No” – and noted the difficulty of educating patients when “so many warnings are required that [a drug ad] scares more people than it helps.”

Robert Bazell, NBC’s chief science and health correspondent – and Read’s interlocutor during a lunch session at the Cleveland Clinic’s annual Medical Innovation Summit – picked up on Read’s comments about excessive warnings on televised drug ads, noting Pfizer’s 2007 Celebrex ad that lasted over two minutes, almost all of which was spent on the recitation of warnings (Celebrex, along with its fellow NSAIDs, picked up a black box warning in 2005).

Responding to the question of why Pfizer decided to go ahead with Celebrex DTC ads, post black box warning, Read said “the trials that gave rise to [black box] labeling in Celebrex, the data, if one patient had gone the other way, there would have been a different statistical result.”

Asked by Bazell about the issue of trust: “What is your perception of the public’s perception of Pfizer and the rest of the industry?” Read said Big Pharma’s reputation could use some improvement. “We’re above Congress and tobacco, and slightly below physicians and hospitals…there is blame on [industry’s] part for that.” Read said increasing transparency in clinical trials and other areas could ameliorate industry’s reputation. “We don’t sell a pill, we sell data. If you believe the data, there must be transparency,” he said.

Read emphasized the importance of incremental innovation to society, the need to protect industry’s intellectual property, and called for an explicit risk/benefit profile for drug development. He called the U.S. tax rate “uncompetitive,” citing tax rates in Europe “as low as 15%.” Industry “can’t work with one hand tied behind our back,” said Read. “Elites have lost faith in innovation as a social benefit…it’s a cost only conversation.”

Thirty years is a long time in any industry. The coalmining industry, the market for air travel, or telecommunications and computing technologies each offer compelling demonstrations of how much can change in such a short period. Few market leaders in those sectors have survived.

Against that background, the pharmaceutical industry has done pretty well over the last thirty years — and so have many of its players. Eli Lilly, Pfizer, Boehringer Ingelheim, Hoffman-La Roche, Merck Sharpe and Dohme — all were big beasts, and they still are. The industry was one of the darlings of the investment community back then, and still today it is seen as one of the safer counter-cyclical havens. And the industry’s enduring qualities as a powerhouse of scientific advance and a generator of high-quality jobs and exports continue to assure drug firms of sympathetic ears in many of the corridors of power.

Survival has, however, been very much the prize of the fittest. In a world grown harshly competitive, many firms have fallen by the wayside, been trampled underfoot, or have simply been lost without trace. Three decades of successive concentrations have thinned the ranks of the industry to a mere shadow of its former self. The roll-call of once-illustrious names has been abbreviated by bankruptcy, mergers and acquisitions. Who now recalls Richardson, which merged with Merrell before being taken over by Dow? There are many working in the industry today who are unaware that a proudly independent Beecham – with its breakthrough work on antibiotics – merged with SmithKline and French before its name was obliterated altogher from the marquee when Glaxo took over the entire operation. The French industry was dominated by Rhône Poulenc and Rousel Uclaf when Sanofi was still a struggling adolescent.

The relentless search for efficiencies, for leaner management, for shareholder value, and for  market share has hit the pharma sector hard. Gone are many of the notorious extravagances of the past. Product launches on the Orient Express or on yachts in the Mediterranean attracted hostility and accusations of a greater focus on marketing than on research. Armies of highly organised sales forces provoked questions among the sceptical about how much success had come to depend on science, and how much on subversion. The rise of a new and assertive form of consumer activism in the 1980s found ample fuel here, and prompted deeper soul-searching among the organisations that were paying for medicines — the consequences of which are still being played out today.

Major advances in diagnosis and treatment (AIDS was an ill-understood but fatal condition in the 1980s) tend to obscure the fact that it is some thirty years since the first blockbuster medicines emerged. Huge optimism was created by the revenues from innovations like cimetidine and ranitidine. But the resulting search for world-beating products not only led to some revolutionary earnings by revolutionary products. It also imposed new economic strains that took their toll of the sector. For many, the development costs and high risk were more than they could comfortably sustain.

In parallel, the operating context was changing rapidly. High-profile cases of big new products with big adverse effects led to some conspicuous withdrawals from the market — and to constantly-rising requirements from regulators who had burnt their fingers through injudicious authorisations. Extensive demands for greater preclinical and clinical testing tightened the screws still further on the industry’s business model, just as the opportunities opened up by biotechnology applications were also making research more expensive and unpredictable. And alongside the strains on innovation, challenges multiplied in the marketplace, from increasingly adventurous generic producers, and the still-sharper elbows of the burgeoning parallel trade sector.

The spectacular increase in international products and international marketing exposed as never before the fundamental weakness confronting the industry in Europe: the divergent national requirements, which split a potentially large market into a patchwork of distinct fragments and hindered the continent-wide launch of innovations. This was the background to the development, throughout the 1980s, of the first attempts at a pan-European system of obtaining marketing authorisations. It was, at times, a painful experience, handicapped (and occasionally even sabotaged) by resistance from national authorities to what they saw as an erosion of their prerogatives, and boycotted by some major firms fearful of concentration of power at European level.

The deficiencies of those initial procedures led to the construction of the more robust mechanisms of the European Medicines Agency. This has, over the fifteen or so years of its existence, brought a new degree of harmonization to product authorization — and extended its authority to a wide range of related issues that have arisen, from advanced therapies to the promotion of smaller biopharm companies.

Over the same period, the industry in Europe managed to persuade the European Union to take action to compensate firms for the growing delays in bringing new products through the ever-lengthening development periods. Patent term restoration legislation and subsequently data protection rules provided some relief for innovators against the depredations of generic competitors.

But if the industry had some success in winning arguments about the merits of innovation, it was conspicuously less successful in convincing national or European authorities to put their money where their mouth was. Attempts by brandname companies to contain the rampant growth in parallel trade  failed repeatedly — and on more than one occasion, spectacularly. European court rulings consistently upheld the EU doctrine of free movement of goods within the EU, and when one European Commissioner acceded to industry urgings to raise the question of overturning this sacrosanct principle, he was left high and dry because industry failed to deliver on its promise to provide him with the supporting evidence. It took years for the industry’s credibility to recover.

More significantly, European countries, even within the EU, retained absolute sovereignty in their decisions on pricing and reimbursement. So the best that the industry was able to obtain was an EU directive requiring national authorities to operate in a transparent fashion about their reasoning for decisions – but the decisions nonetheless remained entirely autonomous, and increasingly parsimonious, so industry gained little or nothing.

This divergence in economic decision-making continues to bedevil the operating climate for the industry — and all the more so as the winds of economic crisis whistle more threateningly. The assumptions that had prevailed for so long, that healthcare spending should continue to rise, are now subject to open challenge. The pressures on drug budgets — which have in any case been an easy target in healthcare financing over recent years — are inevitably increasing as a consequence.

The industry in Europe has been engaged for more than two decades in a protracted  lobster quadrille of round tables, forums and high-level groups with politicians, payers and patients, ostensibly to build a European policy for pharmaceuticals that can guarantee access to medicines while promoting research. But the overall effect has been to blunten rather than sharpen industry arguments for better treatment in terms of market access and adequate pricing and reimbursement.

The recent emphasis on ensuring the sustainability of healthcare systems — a constant theme now in European political debate — is not helpful to industry’s renewed bid for recognition of the importance of innovation.  There is plenty of talk on all sides about the need to promote innovation — in Europe this type of rhetoric has attained epidemic proportions — but the talk is yet to produce any real shift in attitude among healthcare payers. The debates are complicated by new uncertainties over the prospects and perils from advances in areas such as personalised medicine or e-health, or the challenges of providing care for increasing numbers of old people. But it will be unwise of Europe to spend another thirty years looking for solutions. The game has been changed out of all recognition, and the schedule dramatically abbreviated, by the rise of the new economies. No longer will the debate focus on the decline in Europe’s performance compared to the US and Japan. Now the industry lives under the shadow of China and India’s might — and they will not stand patiently aside while Europe reflects on how to maintain industrial competitiveness.

Reflector is Pharmaceutical Executive’s EU correspondent.