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Beyond Borders: Global biotechnology report 2010

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partnering in the pre-competitive space,<br />

for instance, where it makes sense to pool<br />

resources and tackle early-stage scientific<br />

challenges. One prominent example, Enlight<br />

Biosciences, is discussed in some detail<br />

in last year’s <strong>Beyond</strong> borders. Eli Lilly has<br />

launched its PD 2 initiative to attract early<br />

intellectual property (IP) from academia. In<br />

2009, we also saw GlaxoSmithKline open<br />

much of its IP portfolio in neglected diseases<br />

and invite other companies to follow suit (as<br />

Alnylam did in July 2009). We don’t expect<br />

such open innovation approaches to account<br />

for the vast majority of biopharmaceutical<br />

R&D, but it will be an important presence<br />

in certain niche areas — primarily in early<br />

research and preclinical development.<br />

Payors and governments<br />

In recent years, biotech and pharma<br />

companies have faced growing pricing<br />

pressure from governments and<br />

private-sector payors. The drivers of<br />

this trend — rapidly growing health care<br />

costs, the desire to expand access to a<br />

greater percentage of the citizenry and<br />

aging populations — continue unabated,<br />

and as a result, pricing pressures are<br />

expected only to grow over time.<br />

The global recession has further increased<br />

the budgetary pressures on governments.<br />

Tax revenues have plummeted with the<br />

downturn in economic activity, while<br />

policy-makers have had to boost spending<br />

on stimulus packages and unemployment<br />

benefits. In the US market, where health<br />

insurance coverage is largely tied to<br />

employment status, widespread layoffs have<br />

dramatically increased the number of people<br />

at risk of losing access to health care.<br />

Meanwhile, the rules of the game are<br />

changing. Over the last year, significant<br />

health care reforms have been introduced<br />

in some key pharmaceutical markets, the<br />

most prominent among which are the US<br />

and China. These reform measures — which<br />

promise over time to redraw the competitive<br />

landscape, revise rules and regulations<br />

and reorder economic incentives — are<br />

largely attempts to find more sustainable<br />

ways of providing health care in response<br />

to the pressures mentioned above. Not<br />

surprisingly, similar measures are being<br />

considered or enacted across a number of<br />

other major developing markets as well,<br />

from Brazil to Russia to India.<br />

Sweeping changes to health care systems<br />

will, almost inevitably, create new<br />

opportunities and challenges for biotech<br />

and pharma companies. (See A closer<br />

look on the next page for more on the<br />

implications of the recently passed US<br />

legislation.) One of the biggest challenges<br />

may come from the increased adoption<br />

of comparative effectiveness measures.<br />

The fact that many health care reform<br />

efforts need to reconcile two somewhat<br />

contradictory goals — expanding<br />

access to health care while containing costs<br />

— will require increased efficiency across<br />

the health care ecosystem and<br />

will likely increase the adoption of<br />

comparative-effectiveness regimes.<br />

While they have become fairly<br />

commonplace in some European markets,<br />

comparative-effectiveness systems — in<br />

which reimbursement decisions are based<br />

not just on the efficacy of a particular<br />

treatment but on the incremental benefit<br />

it provides relative to cost — have been<br />

largely absent from the US health care<br />

system. That may not change dramatically<br />

in the immediate future; while the new US<br />

legislation provides funding for comparativeeffectiveness<br />

research, it also explicitly<br />

prohibits government payors from making<br />

coverage decisions based on the findings.<br />

Still, the provision is widely viewed as<br />

potentially setting the stage for wider use<br />

of comparative-effectiveness findings in<br />

the US market going forward. Meanwhile,<br />

the significant increase in coverage under<br />

the new law will only increase the need to<br />

control costs — making the future adoption<br />

of comparative-effectiveness considerations<br />

ever more likely. To some extent, the moveto<br />

comparative effectiveness is likely to proceed<br />

regardless of the actions of government<br />

payors. The increased use of health IT,<br />

for instance, will permit anyone with access<br />

to significant volumes of data — hospital<br />

systems, insurance companies and others —<br />

to use data mining to identify which patient<br />

populations a certain treatment is most<br />

effective on. (For examples of such initiatives,<br />

see the <strong>2010</strong> issue of Progressions.)<br />

continued on page 13<br />

“The fact that many health care reform<br />

efforts need to reconcile two somewhat<br />

contradictory goals — expanding access<br />

to health care while containing costs — will<br />

require increased efficiency across the<br />

health care ecosystem and will likely<br />

increasing the adoption of comparativeeffectiveness<br />

regimes.”<br />

11

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