If the UK F.S.A. Is to Truly Make the Most of International Relationships, It Needs to Be A Partner and Not A Parasite

GRAND PLANS AND PROPOSALS

In April of this year we published a Blog – UK FSA Seeks to Plough Its Own Furrow and Set Itself Apart from Its European Counterparts – identifying the FSA’s intentions and aims. Our take was that, while somewhat overdue, it was a positive move in the change of their direction of travel and a promising starting point. We expressed ourselves as follows:

ARE THESE CHANGES THE ANSWER TO ALL OF THE FSA FAULTS?

In reality the answer is “No”, but they are steps in the right direction and demonstrate a willingness on the part of the Agency to acknowledge its faults and failings and look for ways in which it can advance itself. Many of the criticisms aimed at the Agency can be directly attributed to the inheritance post Brexit.

When we left the European Union, we were told that it would allow speedier innovation and progress in the assessment of the safety of new foods. In reality it has not done so thus far, but we hope that these changes are the start of progress – they are not the beginning of the end, but they may just be the end of the beginning.

Since that time we have seen law firms who are trying to break into the Food and Life Sciences areas, together with “industry publications” which parrot and replicate observations without any real analysis of the credibility or cogency of the same, effectively describing the FSA’s proposals as if they were about to transform the entire landscape of food regulation in the UK – they are not and they were ever intended to.

In essence the FSA proposals, when implemented, would mean:

  • that products which are currently required to undergo a periodic formal renewal process in respect of their existing permissions would not be required to do so (noting that this structure relates to feed additives, food or feed containing, consisting of or produced from genetically modified organisms (GMOs) and smoke flavourings); and,
  • that the time delays between an FSA recommendation for Authorisation and actual Authorisation would be shortened because of changes in the administrative and legals mechanisms through which the Authorisation is implemented;

THE F.S.A. PRINCIPLES (FOR NOW)

Beyond these two points of overt proposed action there was nothing else concrete laid out by the FSA, instead there was a commitment to a set of five principles:

  1. The FSA and FSS will actively manage the regulated products caseload so that resources are focused on achieving the best outcomes in the interests of consumers. Active management means making active choices about where to put resources so that the performance of the service as a whole is improved;
  2. The FSA and FSS will review the approach to public consultation and engagement to ensure that it is proportionate and tailored to the needs of consumers and stakeholders;
  3. At all stages of the process, firm deadlines must be set and adhered to when seeking information and input from stakeholders and applicants. Periods of time allowed for further information to be provided must be as short as is reasonable to meet the requirements;
  4. Decisions at each stage of the process should be taken by a lead responsible official, limiting review and sign-off to the minimum required to meet quality standards and to achieve three – and four-country working; and,
  5. The FSA and FSS must continue to make a strong case to Ministers that, without adequate resources and/or further changes to the process, performance of the current service will fail to deliver timely outcomes for the benefit of consumers and food businesses.

Again, our take on this was a relatively positive one because we know from long experience of the regulatory black-holes into which Dossiers can fall when it suits the under-resourced and under-staffed regulator and the apparently obligatory timescales imposed upon them suddenly become aspirational.

Therefore, a public commitment to the principle of good timekeeping on their part was/is positive, however, the test will always be whether the FSA live by and stick to these stated principles (it’s too early to tell yet) and, as we have seen before, regulatory authorities are not beyond studying at the Graucho Marks school of ethics: “Those are [our] principles, and if [we] don’t like them… well, [we] have others.” In fairness they also need the resources provided to them by central government and not least to have a government in place (purdah now being an active factor).

THE LAUDING OF A NEW DAWN IN INTERNATIONAL REGULATORY CO-OPERATION

It now seems that any announcement or public comment by the FSA is seized upon by law firms and publications, who then appear to immediately place what we would describe as an overly-positive spin on the material – while no doubt imploring the next potential client (law firm) or advertiser (publication) to get in touch before the regulatory [gravy] train has left the Station.

At AFR we are not – and never have been – of a “Bah Humbug” or defeatist mentality, but what we are is realistic, open and honest with clients and (when we choose to publish our thoughts and analysis) the wider market who care to listen.

In 2022 we were hosting a conference Q&A with (by then) the ex-CEO of a Consumer-Packaged Goods company who had been given $5bn (yes, Billion) of a majority investor’s money to grow the business. He duly spent it, every cent of it, through stupid and loss-making acquisitions, through absurdly mad science and flights of fancy. What was most shocking to us was that he was proud of it, he explained that he was “pushing the boundaries” and that he was “ahead of his time”. He concluded by telling us that, in any event it was OPM and he was fine. When we enquired as to what was meant by “OPM”, he told us – “Other Peoples’ Money”. Shocked was an understatement.

Our experience in Food and Life-Science regulation is based upon and borne out of a fundamental knowledge of the area and the methods and tactics to be deployed so as to ensure that clients’ aims can be achieved and that they are fully aware of the demands (whether that be in time, money, energy and/or exasperation) that engagement with regulatory authorities will place upon them.

It has been said to us many times that when we meet potential clients for an initial scoping exercise that we have “The worst pitch in history” because we provide a ‘warts and all’ description of the path that they are considering embarking on – it is our view that that is absolutely what they are entitled to and that it is our professional obligation to provide it to them. It may be their money, but we treat it like its ours and given that the two Founders of AFR are both Northern Council Estate kids, if a client’s money gets spent – it gets spent wisely.

And so, we come to the latest “New Dawn” being reported on by other firms and the industry press relating to observations made by a senior member of the UK FSA. We see the perfect trinity of an echo-chamber:

  • lawyers/consultants wanting to recruit new clients;
  • the press wanting to boost interest in a sector from which they derive publication revenue; and,
  • the regulator who needs/wants to be seen to be moving forwards – strident and progressive when now no-longer able to ween from its dominant “mother” (EFSA) and without the comfort blanket which she provided.

SO, WHAT IS THIS NEW DAWN?

Peter Quigley, Deputy Director of Regulatory Services at the FSA, was speaking recently at a forum in Westminster and indicated that proposals were being discussed which would allow for regulatory agreements between countries and for regulatory approvals to be written in to trade agreements with other countries around the world. He said the FSA was planning to use a “sliding scale of international engagement” and that “As the UK regulator, we’ve been in touch with colleagues in Singapore, colleagues in Australia, New Zealand, and all over the world”.

On the same topic, FSA Chair Professor Susan Jebb said: “One of the options we have asked officials to consider is the possibility of extending the way we work with regulators in other countries where we are aligned in the safety standards of foods. This could involve greater sharing of information or technical expertise as we assess the potential risks, whilst maintaining autonomy over decision-making.”

What we have read recently are observations from some within the echo-chamber suggesting that this will place the UK at the forefront of all new and innovative food products, such as alternative proteins, cell-cultured meats etc. but, as currently structured and funded, it will not do so.

What statements such as this are (other than platitudes for those within the industry who wish to place false hope on them), are self-aggrandising posturing of an entity which is seeking to project power, authority and credibility to similar entities around the world who are potentially willing to listen (and to “mother” who is not in the slightest bit interested in what the prodigal child says or does). Furthermore, what they are, are a manifestation of the consequence of the fifth Principle stated above: The FSA and FSS must continue to make a strong case to Ministers that, without adequate resources and/or further changes to the process, performance of the current service will fail to deliver timely outcomes for the benefit of consumers and food businesses.

They are really a funding call to Ministers that they need to be better resourced, utilising the “Carrot” (of “Carrot and Stick” fame). We understand that the internal funding pitch to Ministers/Treasury goes something like this:

“if the UK FSA is better resourced then we could form a collective with other international regulators through which we can share the regulatory cost burden of each of us assessing the very same products, resulting in a lesser overall spend by ourselves (i.e. by you) but with a proportionately greater output for that spend. So, a lower aggregate cost with a greater output means output/£ (i.e. efficiency) increases hugely, and so we all look good [and by the way there may some incidental benefits to UK businesses and the consumer, but you’re a Politician/Treasurer with only short-term views and so this isn’t the main pitch which is – in case you have forgotten – we all look good!]”

WHAT IS THE AFR VIEW?

We are all for it – with a healthy dose of realism!

Let us assume that the Funding Pitch worked and the commitment to increase the FSA budget by the necessary amount was agreed at Ministerial and Treasury level today (the day that a General Election in the UK has been announced).

Let us further assume that the incoming Government (which according to the Polls is highly likely to be a new Party which has not been in power for 14 years), maintains the same commitment as agreed by the current government today. Therefore, the earliest by which the additional resources would be in place would be Autumn 2024.

Time would be needed to recruit the man/woman-power who will negotiate the terms of the international treaties and then staff the international-liaison department. Assuming that the people recruited are decently high-level in their current environments then they would not be in post for 3-6 months, assuming that they underwent all of their interviews and were offered their respective positions on the first day of recruitment. One would suggest that the department will not be staffed until Q2 of 2025 (which is a year from now).

Once in post the department will have to identify the most appropriate international regulators with whom it wishes to deal and then engage in negotiations with them. As we know, nothing in the regulatory world happens in a timescale that anyone in the real world would describe as quickly and so one could suggest that this might take a further 6 months (we’re now at the end of Q4 2025).

Negotiations would then need to begin and the safety parameters acceptable to the UK and the respective partner(s) would need to be agreed in order to ensure that both parties were happy with the principles. Thereafter, there would need to be further agreement as to the data requirements necessary in order to underpin those safety parameters. We would expect that the shortest timescale for such discussions would be 12-18 months – which would take us to either the start of (or the middle of) 2027.

The respective governments would not be able to sign the Treaties immediately because all other relevant departments who may be affected by the Treaty would be required to be consulted and, for them, it is not a priority and so one would need to allow a further 6 months (we’re now at Q3 2027 or Q1 2028).

The government would then need to finalise the Treaty following the end of the consultation period and so if we took a wholly unrealistic period to 3 months for them both to do so, we would find ourselves at Q4 2027 or Q2 2028).

Up to this point the two regulatory authorities have been in the honeymoon period with each other, but it is at this point at which the real inter-department political arm wrestling begins (akin to who has the most (or any) wardrobe space, who uses the toothpaste first, does the dishwasher have to be stacked in a certain way etc.).

How the respective authorities would divide up work would be unknown, especially where there is no duality of appetite for the innovative product in both jurisdictions. But most importantly, the question will arise as to who is going to have to do more of the grunt work and who will be able to coast along and seek to have the benefit of the work undertaken by the other and, in circumstances where there is a disparity in respect of work already undertaken, will the other party be given “free” access to that existing work or are they going to have to “pay” for it in terms of taking the greater burden of future work – and given that the relationship will have been costed on a pre-defined basis, will the “payer” have the budget to undertake a disproportionate share of the future work?

Hopefully the UK FSA would have been sensible enough to negotiate a position where they had to be given “free” access to existing work undertaken by the counterparty in return for a shared burden moving forwards. If so, this will provide a short-term boost after the point of commencement of the agreement in which the UK might gain access to data and be able to authorize products far quicker than it would have done in comparison to the state of its own progress on the assessment of those products, however, that will be short-lived and when it has “caught up” with the other jurisdiction, it will then fall back into its standard pace, but with the benefit of parallel work being undertaken elsewhere such that there could be a multiplier effect to authorisations.

And if you’d forgotten, by this time we’re already in 2029 or 2030 – by which time there would have been another General Election in the UK and one would have to hope that the funding commitment remained constant.

OUR CONCLUSIONS

At AFR we are a manifestation of international co-operation – we have staff based in 5 countries who all work collaboratively on projects – and so we encourage and support the proposals of the UK FSA to work in a similar vein with their international counterparts.

However, one must be realistic about the practicalities of doing so and honest about the timescale in which they will be able to do so.

Those within the industry who are currently dangling this “Carrot” as a game-changer in anything other than the (in the context of food evolution) long-term view are advancing false and unrealistic hope – the carrot will be dehydrated, it will be shriveled, mouldy and passed the point of being fit for human consumption many, many years before.

This is a positive proposition, but not in the context that some in and connected with the food industry are seeking to position it.

Remember what we always say: Be Careful Who You Listen To.