Pharmaceutical

What type of pharmaceutical projects can qualify for R&D tax credits?

Although similar to other industries, the types of pharmaceutical activities considered R&D are different due to the nature of testing procedures required to meet regulatory requirements. The time taken from the earliest research stages on a particular drug to market is usually in the order of a decade. And only a small percentage of promising compounds identified in early research end up with regulatory approval.

What projects can be included in an R&D Tax Credit claim for the Pharmaceutical industry?

R&D in the pharmaceutical industry typically takes place in four stages:

• Drug discovery

This phase is concerned with the identification of promising new chemical entities.

• Pre-clinical trials

Pre-clinical trials are concerned with the non-human testing of compounds. Compounds that are identified as promising at the pre-clinical trial stage move into clinical trials.

• Clinical trials

Clinical trials go through three phases, they could generally be described as toxicity tests (phase 1), preliminary efficacy tests (phase 2) and comparative efficacy and tolerability tests (phase 3). Work in these first 3 stages will likely be considered R&D. This will likely include work on applying to and responding to the regulator, and work on doing further testing as requested by the regulator. Most of the work involved in making an application to the regulator would involve work that directly contributes to the resolution of technological uncertainty and would therefore qualify as R&D.

• Post-launch

The post-launch phase occurs when a product has been licensed. Thus this phase involves post-marketing confirmatory studies, special interest studies, longer-term efficacy, tolerability etc. Work in this phase would generally not be considered R&D unless the work involved a scientific or technologically advanced uncertainty.

How to decide what qualifies as R&D in the Pharmaceutical industry?

It seems to be the case that the research activities of discovery, pre-clinical development and Phase 1-3 trials will usually be concerned with the resolution of scientific and technological uncertainty, but that phase 4 (post-launch trials) will not. Our experience has shown that this is generally an appropriate starting point for examination of claims from pharmaceutical companies. If there are unusual circumstances meaning R&D is done in Phase 4 trials, or not done in some elements of phase 1-3 trials, then this can be examined further. What is important with every claim is that the company claiming can demonstrate by reference, what it has actually done and that the expenditure incurred is based on R&D.

Why choose Myriad Associates as your specialist R&D tax credits advisor?

By profiting from our specialist knowledge and experience, you can be sure of maximising your R&D tax relief claim. As a rule, Myriad Associates submit R&D tax relief claims that are up to three times higher than in-house prepared claims or those filed by generalist accountants.

• We handle your R&D claim from start to finish, taking up just two to three hours of your time.
• We can maximise your R&D claim because our expert consultants can identify your qualifying projects and all your eligible expenses.
• We write technical reports describing your projects to support your claims.
• We make sure Revenue handles your claim promptly, because of our right-first-time approach and because of our outstanding relationship with R&D tax inspectors.
• Our 5-Step Claim Process is simplicity in itself, so you always know where we are with your claim.

• 100% success. We have successfully claimed R&D tax relief for all our clients, for over ten years, and without exception.
• An unbeatable offer. Confident of delivering a winning service, we offer our services on a success-only basis.