Making Britain The "Fastest Place" For Pharma R&D Adoption

By Neal Learner, Contributing Editor

Competition in the pharmaceutical industry isn’t just about which manufacturer discovers the next blockbuster pill. National governments and entire geographical regions compete fiercely to attract pharma companies and the billions of dollars that come with their high-value investments. The United Kingdom is the latest country to try and step up its game.

The U.K. government in June unveiled details of its Accelerated Access Review (AAR) initiative, which aims to make the U.K. nothing less than, “the fastest place in the world for the design, development, and widespread adoption of medical innovations.” British manufacturers naturally welcome the effort, but contend the country has a ways to go in meeting its ambitious goals, especially in the adoption of new medicines.

“New medicines can play an important role in transforming patients’ health, but in the U.K., patients are not getting access to these medicines,” says Alison Clough, acting CEO at the Association of the British Pharmaceutical Industry. “We lag considerably behind comparable countries when it comes to patients benefitting from new medicines.”

Indeed, the uptake of innovative products launched between 2007 and 2012 was slower in Britain than in 16 other industrialized countries, according to the U.K. government’s report Life Science Competitiveness Indicators. The U.K.’s uptake is only 11 percent of the average of other developed countries after one year, less than a third of the average after two years, and still only half the average after four years, Clough said in a statement regarding the study.

“Not only is this a disadvantage for patients in the U.K. who are not able to access the newest, most innovative medicines when they need them, but we can now see that this is a disadvantage to the country as a whole impacting our global competitiveness,” she said.

The government’s competitiveness report bears this out. The total value of goods and services (i.e., gross value added) generated by the pharmaceutical industry declined from a high of nearly $24 billion in 2010 to roughly $20 billion by 2013, where it remains flat. Furthermore, government spending on R&D has declined in recent years, as has the share of U.K. patients recruited to global studies. On the bright side, the report found that the number of science graduates and employees in Britain’s pharmaceutical manufacturing industry is gradually rising.

AAR LAYS OUT KEY THEMES FOR REVIEW
To improve the overall picture, the AAR initiative will focus on several key themes for review. These include establishing the need, priorities, and principles for innovation; exploring new development pathways; aligning national funding models to drive innovation; and speeding up local adoption and diffusion of innovative products.

Leaders associated with the AAR say the goal is to better understand the needs and demand for innovation, which can then be translated into research followed by accelerated development of products. “We aim to translate the unique features of our science and healthcare system into meaningful benefits that will attract innovators to conduct their R&D in the U.K.,” Stuart Dollow, founder of Vermilion Life Sciences and a member of the AAR expert advisory group, said in a late June posting on the government’s website.

Dollow and others involved with the review aim to finish their initial work by the end of the summer and will look specifically at making reform recommendations in three areas:

• REGULATION – The goal will be to quickly assess safety and efficacy of innovative products by better exploiting the U.K.’s advantages as an integrated healthcare system with renowned research medicine ethics and infrastructure.
• REIMBURSEMENT – The AAR seeks to adapt systems of health economic assessment that reflect technological advances in genomics, precision medicine, and informatics; reduce time and risk from the traditional R&D model; and develop new models of reimbursement for innovative products (such as payment by results).
• UPTAKE – The plan is to ensure that the National Health Service (NHS) can better support and drive medical innovation.

Clough says the industry has urged the British government to take a comprehensive approach to drug discovery, development, regulation pricing, value assessment, and usage. This includes better aligning recommendations of coverage made by the National Institute for Health and Care Excellence (NICE) with the approvals granted by the NHS England. “A key change needs to be the formation of a holistic research and health system, which supports both the development of research in parallel with faster patient access to modern medicines,” says Clough.

LOOKING FOR EARLY APPROVALS
U.K. drug giant AstraZeneca (AZ) agrees the country could do more to speed up delivering products to British patients. An AZ spokesperson tells Life Science Leader that the manufacturer would like to see NICE’s value-assessment framework for new pharmaceuticals better aligned with the European regulator’s approach, which has sought to accelerate approvals for medicines in disease areas with limited treatment options. Unfortunately, today, the system consists of a disjointed patchwork of regulatory and value-assessment bodies, which ultimately delays access for patients.

According to AZ, the formation of a system that lets patients access newly licensed medicines that have been approved on the basis of early trial data would be extremely welcome. “This would enable U.K. patients to gain early benefit from new specialized treatments, particularly where there is unmet medical need,” the spokesperson explains. “The advent of personalized healthcare and targeted treatments requires innovation in trial design and development pathways — regional regulators must be prepared for medicines of the future being developed now.”

Other national oversight bodies, including the FDA and the European Medicines Agency (EMA), already are piloting initiatives in which drugs may be approved on a graduated basis as more evidence is brought to light on the safety and efficacy of the products.

“The [AAR] review should be about improving access to the latest treatments with a view to improving long-term health outcomes,” AZ’s spokesperson says. “The U.K. has a poor record with regards to access as demonstrated by the government’s own life sciences competitiveness indicators.”

U.K.’S COMPETITIVE POSITION STILL STRONG
But not everyone sees the U.K. falling behind in the race to attract pharmaceutical activity. A June report commissioned by PhRMA finds the U.K. second only to the U.S. among 16 markets on overall attractiveness for biomedical investment. The U.S., U.K., Switzerland, and Ireland, respectively, have the highest overall scores, and their biomedical environments fall into the category of “strongly competitive” relative to the other sampled economies, says the report released in late June. “All four boast excellent and effective scientific research systems, regulatory frameworks that meet the highest international standards, pricing and reimbursement systems that provide comparatively better opportunities for market access, and generally positive market conditions,” it added.

PhRMA’s 2015 Biopharmaceutical Investment & Competitiveness (BIC) survey noted that while the U.S. and U.K. particularly excel in the quality, scope, and effectiveness of their scientific research systems as well as clinical research capabilities, Ireland and Switzerland lead the pack in manufacturing capacity. “The U.S. and Switzerland dominate the charts in terms of providing effective intellectual property protections,” the report notes. “It also is worth mentioning that, not surprisingly, these economies have reached these levels of success predominantly through the use of market-based pro-innovation policies and initiatives, including policies aimed at biomedical products.”

The BIC survey examines the overall ecosystem in which biomedical innovations take place by looking at several key areas: (1) ability to leverage scientific capabilities and infrastructure; (2) state of the clinical environment, from test tube to patient; (3) quality and efficiency of biomedical manufacturing and logistics operations; (4) soundness and effectiveness of the biomedical regulatory framework; (5) healthcare financing; and (6) overall market and business conditions.

The U.S.’s score on this BIC survey was 86.88, the U.K.’s was 82.60, Switzerland’s was 82.56 and Ireland’s was 82.17. By contrast, China had a score of 57.62 and Brazil had a score of 56.57. The top four performers all experience challenges in certain areas that do not permit their overall scores to rise above 90 percent of the total score possible, the report noted.

In the U.S., the hurdles include a public pricing and reimbursement system for Medicare and Medicaid that is fragmented and sometimes difficult to navigate effectively. In the three other top countries, pharma executives cited fairly stringent price controls on both public and private drugs among the challenges. Governments in these countries, at times, are missing the link between investment, research, and market access in a timely manner and at a fair price, according to the report. In addition, both the U.K. and Ireland experience gaps in how they translate and commercialize research into new products. Market access incentives also are undermined by heavy use of parallel importing of medicines.

Despite the challenges, local U.K. executives still view the U.K. as a top global destination for biomedical investment. Survey respondents point to a 2014 initiative that offers companies favorable taxes on income earned from intellectual property generated in the U.K. Since implementing the new tax incentive, the economy has reported a surge in biotech investment, the report said.

Leaders of the AAR also are taking an optimistic view that the U.K. can position itself to become even more welcoming for pharmaceutical investment. “With our strong science and national healthcare system, there is untapped potential for greater research involvement and global influence to be translated into improved health,” says Dollow.