What Is the Real Meaning of Pharma Innovation?

Britain’s NICE (National Institute for Health and Clinical Excellence) is charged with providing guidance on promoting good health among citizens of the U.K. Unfortunately, NICE has had a contentious relationship with the drug industry in general, and has often been viewed not as a promoter of public health but rather an impediment to innovation which might benefit the public. One way to put it: “Pharma sees NICE as a barrier to its ambitions to bring products to patients. NICE sees itself as the guardian of the public purse and of all patients.”

The above statement is from Sir Ian Kennedy, who was hired by NICE earlier this year to review the organization’s procedures and make recommendations for how it might turn things around—i.e., “make nice” with pharma while still protecting the public interest. Kennedy has issued his final report, "Appraising the Value of Innnovation and Other Benefits," with a laundry list of recommendations for NICE. But, for those of us outside the U.K., we might find most compelling Kennedy’s ruminations on the meaning of innovation within a pharma context. Here are some of those thoughts, from the report:

“ . . . It will come as no surprise that, while everyone was content to use the word [innovation], and everyone agreed that it was a good thing, it was not easy to identify what was being discussed. In fact, as is common in policy-making, the absence of any hard centre of meaning allows people from all quarters to appear to be in agreement, without the need to nail down what it is that they were agreed on.

4.8 There is no shortage of definitions of innovation. Their very number suggests an amorphous concept. It is clear to me that the notion of innovation has a range of connotations which are, to a degree, context-specific. And, the world of pharmaceutical products is one such context. As a first step, it may help to know what Sir David Cooksey had in mind when he called for this study. When I spoke to him he referred to innovation as connoting “different ways of doing things which bring improved outcomes”. This helps. There is the idea of difference, or newness, and the idea that it represents an improvement on what went before. . . . it should be clear that something more than newness (or difference) plus some degree of improvement in effectiveness may be necessary to qualify as innovation in this specific context. . . .

4.10 Where innovation becomes important, therefore, is when Pharma states that a product meets three initial criteria, in that the product: But, they will not warrant any special treatment. Only if they are priced in a way that meets NICE’s established approach, will they warrant approval. Such products may be described as innovative, but the claim alone will cut no ice, nor bring any special treatment.
• is new
• constitutes an improvement on existing products
• offers something more: a step-change in terms of outcomes for patients

Kennedy agrees that “step-change” is in itself amorphous as well, but this is what we should by striving for as an industry, and this is the concept around which NICE and pharmaceutical companies can coalesce to expedite products to market that are truly “innovative.”

--Paul Thomas