Can you save costs in a Regulatory Affairs Department?
Yes – it can be challenging to include Regulatory in company-wide cost saving goals since the majority of the work we do is unavoidable and essential to maintain the licence to sell medicines. However, there is a misconception that you can’t save costs since fees are non-negotiable or that there is risk of non-compliance.
Since us ‘regulatory folk’ tend to be more compliance focused than commercially driven, you may need to reset the mindset of the team first so that they understand its importance and start to look for ways to save costs – and time! Do this by setting them finance goals and empower them to get creative whilst ensuring any cost-saving activity is realistic to avoid those compliance risks.
I have laid out some potential quick wins below, as well as some longer-term goals. It is written with a UK slant but can easily be applied across the globe!
Start with planning
- Ok, this is not strictly speaking ‘cost-saving’, but it allows you to know your starting point.
- Put in place regular meetings with key contacts to gain an understanding of upcoming changes e.g. Global RA, labelling, CMC team, manufacturers, suppliers, commercial.
- Once you have this, predict the related fees (assume an increase each year), the MHRA fees calculator may be useful.
- From this point you can determine how much you need to save, the below points will hopefully offer some creative solutions…
Regulatory strategy
Your team should ensure that cost is always considered when planning a submission, even when it is essential. Depending on the type of submission there are different ways to reduce costs:
- For high-cost submissions such as MAAs and line extensions, it is paramount to review all the pros and cons of the chosen submission route – for both short and longer term cost implications.
- Compared to the national route, the International Recognition Procedure is cheaper and quicker.
- ‘Grouping’ – review the MHRA guidance on grouping to determine if your submissions are eligible, if so they will attract cheaper fees, take less time to manage internally and only have one implementation timeline (reducing impact to artwork and supply chain).
- ‘Bulking’ – where the MHRA criteria is met, the first application is charged at the full rate and all subsequent applications are charged at 50%.
- Some submissions are legally required (e.g. safety related changes) and must be prioritised, however there will be some submissions that may be possible to delay to a new financial year (if advantageous).
- If you are outsourcing eCTD publishing activities, are they offering a cost saving when a document is being used across multiple submissions?
- Batch Specific Variations (BSVs) can be very helpful when trying to avoid a write-off situation or a medicine shortage – engage with the authorities / DHSC early to determine if they would accept a BSV under your circumstances and expedite the review.
Quality of submissions
- The MHRA charge a 10% admin fee for all rejections – if you have a high number of rejections, review the reasons and avoid repeat mistakes.
- Technical reasons related to eCTD publishing can exist and result in validation queries, determine if your provider is costing you time.
- The MHRA have published checklists to work through to support your ‘right first time’ submission.
Processes, systems and access
If you work in ‘big-pharma’ you may have limited autonomy to update your processes and systems, but local practices should still be reviewed for opportunities.
- Are your processes and systems efficient? Or are you duplicating certain actions, filing documents in 3 different places, recording data in 4 different systems / spreadsheets?
- Are you 110% inspection ready when you could reduce that to 90% and do a little more work as and when you need to?
- Are you paying for fancy software that isn’t delivering on its promises?
- Can you consider cancelling unused or low value/high cost services such as RAMA XL? (sorry MHRA!)
- Does everyone in the team need TOPRA membership? (sorry TOPRA!)
Periodic licence fees
- Only maintain licences that you are likely to market (or have other advantages such as reference market)
- Obtain the latest information from the finance department, don’t reuse sales figures you could be overcharged.
- Sell/divest licences rather than cancel – Commercial, Legal and Finance Departments should review/lead this, but do ask if this was considered before going ahead and cancelling a licence.
SME
- Gaining SME status with MHRA and/or EMA can save you a lot of money as well as a whole suite of other benefits.
- SME status is open to pharmaceutical companies that have a turnover of ≤ €50m (in EU) and/or ≤ £36m (in UK).
- Use our eligibility tool to determine if you meet the criteria and what savings can be made.
- We offer this service for FREE!!!
Dare I say ‘de-branding’
The purpose of ‘de-branding’ is to remove your product from the VPAG scheme – potentially saving millions.
This is not strictly speaking a Regulatory driven project but the RA team will be able to review the products that could be de-branded and advise on submission timelines and next steps.
I will do a post on de-branding soon but for now let me just say, this is legal and other companies are doing it! Book a call with us if you want to discuss this further.
Headcount
Like with any department this should be reviewed regularly as well as when there is a decrease in the number of licences the team are responsible for. Here are some other considerations to make:
- Could you take on a graduate and train them – in my recent experience they are very high calibre and keen to make an impact.
- By reviewing/streamlining processes/products, could this reduce the headcount required?
- Are you utilising your contractors effectively – they are often the most experienced (and expensive) and should be capable of handling more work than more junior members.
- Do you have huge contractor fees? If so, take a look at this article which looks at the cost benefits of choosing a regulatory consultancy over a contractor.
Implications for other departments
- Marketing materials are costly to update – ensure Regulatory are liaising frequently with Marketing and understand when an update is required. Grouping variations or asking the authorities for a slight delay in implementation can avoid unnecessary writ-off costs.
- The frequency of packaging and PIL updates can again be reduced by grouping and/or strategically timing submissions, thereby reducing material write off costs
- Work closely with Supply Chain to ensure they understand the length of time they can sell ‘old’ product when a change has been introduced. There is also flexibility on this depending on the type of change i.e. safety Vs administrative.
Working with Fusion Pharma can actually save you money – ask us to do a review of your department to identify opportunities to save money, or engage with us instead of contractors and reap the other benefits too.
Contact us to discuss your department’s needs and how much you need to save!
