If your company is in the pharmaceutical industry and you've recently introduced a new drug or developed a new piece of technology then there is a strong chance that you could benefit from an R&D Tax Credit claim.
Below we've created 5 simple sections to help you understand how R&D tax credits work in Pharmaceutical and whether your business could make a claim.
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.
R&D in the pharmaceutical industry typically takes place in four stages:
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.
"It was good to work with a team who are dedicated to their field and know the law, the claims process, the pitfalls and who knows how to draft the technical reports at speed. I can't really complain about how the R&D claim was done. We were very, very happy"
Conor Quaine
Head of Finance, CitySwift Ltd
If your company is taking a risk by innovating, improving, or developing a process, product, or service, then it will likely qualify for R&D tax credits.
A good test to determine if the work undertaken qualifies as R&D, is whether your project team faced uncertain outcomes at the start of the project.
That means that your team did not know from the outset whether a particular outcome was achievable.
If you can show that your project goes beyond simply applying existing technologies, then you may be eligible to make a claim.
Speak to our specialist team today and we can help you to decide whether your business meets the relevant criteria and whether any credits can be applied for the R&D projects you’ve undertaken.
Find out if you’re eligibleCompanies can often under-claim for their R&D work or even disregard it as they believe they won’t qualify for R&D tax relief. That’s when you need an R&D tax credit specialist like Myriad Associates. Having spent over a decade filing R&D claims and with a 100% success record, Myriad Associates will identify all your qualifying projects, all your eligible expenses and get you the maximum amount of R&D tax relief possible. Plus, thanks to our right-first time approach, we have a strong relationship with the Revenue which means your claim will also be handled quickly. All we need it just two to three hours of your time and you can leave the rest to us.
About Myriad AssociatesThe types of pharmaceutical activities considered to be R&D are different to other industries because the testing procedures that need to be followed to meet regulatory requirements are long, thorough and strict.
The time it takes from the earliest research stages on a particular drug to get it to out to market is usually about a decade. And only a small percentage of promising compounds identified in early research end up with regulatory approval.
R&D in the pharmaceutical industry typically takes place in four stages:
This phase is concerned with the identification of promising new chemical entities.
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 go through three phases, 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 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.
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.
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.
If your company is taking a risk by innovating, improving, or developing a process, product, or service, then it will likely qualify for R&D tax credits.
A good test to determine if the work undertaken qualifies as R&D, is whether your project team faced uncertain outcomes at the start of the project.
That means that your team did not know from the outset whether a particular outcome was achievable.
If you can show that your project goes beyond simply applying existing technologies, then you may be eligible to make a claim.
A business must submit its R&D tax credits claim within 12 months of the end of the accounting period during which the R&D activities took place. To make a claim, the business will need to complete the CT1 form through the Revenue Online System. More details can be found in our blog: How Far Back Can I Claim R&D Tax Credits In Ireland?
Step 1 of #
Thanks for that!
We would like to help you decide whether your business meets the relevant criteria and whether any credits can be applied for the R&D projects you’ve undertaken. Please click on the button below to speak with an expert.
Thanks for that!
We would like to help answer any questions you have regarding the R&D tax credits scheme. Please click on the button below to speak with an expert and one of our specialist team will get in touch.
Thanks for that!
We would like to help answer any questions you have. Please click on the button below to speak with an expert and one of our specialist team will get in touch.
Speak to an expert Back