European Regulation to enforce the Nagoya Protocol

European Regulation to enforce the Nagoya Protocol

On 17 April 2014, the following letter from Roger Burt (CIPA President) and consultation response was submitted by CIPA and sent to Richard Early at the Department of Food and Rural Affairs. Many thanks to Tim Roberts and the Life Sciences Committee. In response to the Consultation on the proposed Regulation to enforce the Nagoya Protocol, we enclose the Institute's comments [see below]. Recognising that the Regulation will shortly become part of EU Law, we have sought to be as constructive as possible. However, we fear that it will cause severe difficulties for both academic and industrial researchers. The Regulation (it seems to us) is based on three propositions:

  1. Research on all non-human genetic resources (GR) is, in principle, controlled by some country or other.
  2. It is usually quite simple to determine which country, and get the permission you need.
  3. All GR research is elective – if you cannot get the permission you need, and so can't do the research, this does not matter.

In our view, 1. is dubious, while 2. and 3. are simply false. The uncertainty about who controls any particular genetic resource will cause endless trouble. It may lead to a major outflow of important research, in particular to the USA. As the USA is not bound by Nagoya, it will be increasingly attractive to researchers seeking to avoid the problems the Regulation poses.

In fulfilling its obligations under EU law, the UK should make every effort to minimise the difficulties that will arise from these false assumptions.

 

CIPA submission to Nagoya Regulation Consultation

Summary

1. To ratify the Nagoya Protocol will be a major mistake. Two fundamental objectives of the CBD are to increase access to genetic resources and develop their uses. Nagoya will frustrate these, rather than promoting them.

2. Since the Regulation commits the EU to ratification, the task for the UK is to implement it in the least damaging way possible.

3. A profound danger of the Regulation is its lack of clarity. Fear of offending unintentionally will drive researchers to be over-cautious, and avoid valuable research. Research, and researchers, may be driven overseas – in particular, to the USA. In the USA, not bound by Nagoya, research will remain unaffected by the many uncertainties caused by the Regulation.

4. Accordingly, DEFRA should concentrate on educating the public on the requirements of the Regulation. Its many ambiguities should (if possible) be clarified. Criminal sanctions are inappropriate and must be avoided.

Answers to the specific questions posed in the Consultation are given below (para. 31).

Preliminary

1. This is filed in response to the consultation by DEFRA on the Nagoya Regulation, published 21 March 2014 and due for response by 21 April 2014.

2. The Chartered Institute of Patent Attorneys (CIPA) was founded in in 1882 and was incorporated in the UK by Royal Charter in 1891. It represents virtually all the 2000 or so registered patent attorneys in the UK, whether they practise in industry or in private practice. Total membership is over 3,200 and includes trainee patent attorneys and other professionals with an interest in intellectual property (patents, trade marks, designs and copyright). It became, by the Legal Services Act 2007, the official regulator of the patent attorney profession in UK, its regulatory functions being carried out independently of the membership. Members advise clients on a wide range of intellectual property matters and represent all types of enterprise both large and small before the European Patent Office and the UK Intellectual Property Office, in prosecution, in oppositions, and in other contentious proceedings.

3. Neither CIPA nor its members deal directly with genetic resources. However, our members have numerous clients who research with genetic resources and subsequently file patent applications on the results of such research, generally with a view to later commercialisation. They will require advice on what they may and may not do when the Regulation comes into force.

4. CIPA very much regrets that the European Union (EU) has decided to ratify the Nagoya Protocol. The Institute strongly believes that the Protocol is ill-judged. Its scope is uncertain. As a matter of principle, any restrictions on research are illiberal, and justified only in specific and exceptional circumstances. Here, the proposed restrictions cover a very wide field (all genetic resources except those from humans). They include, in circumstances that may easily arise, an absolute embargo on (potentially life-saving) research . The Protocol will not (in our view) advance the objectives of the Convention on Biological Diversity (CBD), that is to say, to conserve biological diversity, to promote its sustainable use and to share fairly the benefits of such use. On the contrary, by bureaucratic over-regulation and imposing vague and impractical conditions, it will discourage research on biodiversity, leading to fewer benefits to be shared. The fewer the benefits resulting, the weaker the motive to conserve. However, we recognise that the EU has decided to ratify the Protocol and that the form and content of the Regulation is settled. In these circumstances the Government's objective (we believe) must be to minimise the damage that will result. Despite our grave doubts about the Regulation, we will seek to comment as constructively as possible.

5. In these comments, we do not deal with 'traditional knowledge'. This topic has its own problems. But traditional knowledge, however important to its possessors, is very much less important to the rest of the world. Genetic resources (hereafter 'GR') are essential to the life and health of everyone and are used in all spheres of life: traditional knowledge is orders of magnitude less significant. Leaving traditional knowledge out of consideration also makes it easier to construe the legislation (without, we believe, changing how it affects GR). Throughout, references to 'Articles' (unqualified) are to Articles of the Regulation. History and Purpose of the Regulation

6. The Nagoya Protocol builds on the Convention on Biological Diversity (CBD) signed December 1993. The objectives of the CBD are threefold: to conserve biological diversity; to increase its availability for sustainable uses; and to share the benefits of such availability fairly. In pursuit of the last objective, it is often claimed that the CBD conferred ownership of genetic resources on host nations. This is a mistake. What the CBD did was to apply the existing principle of sovereignty to genetic resources (GR). The principle of sovereignty recognises that – broadly – a nation has control over everything happening within its borders. The corollary is that this control does not extend outside its borders – there control passes to others, or ceases. What the CBD did was to apply the principle of sovereignty to access to GR. It provides (Article 15) that countries will provide access in their territories to GR in two specific cases: where the country in question is the 'country of origin' for that GR; where the GR has been received 'under this Convention'. In both cases, the access requires Prior Informed Consent (PIC) of the country giving access, and is to be the subject of Mutually Agreed Terms (MAT) between the provider country and the recipient. In the absence of the CBD, the host country would have no obligation to provide any access.

7. It is clear from the CBD that no new rights over GR are conferred. One Recital reads: “Reaffirming that States have sovereign rights over their own biological resources” . This does not suggest any change, radical or otherwise. Likewise, Article 4 states: “Subject to the rights of other States, and except as otherwise expressly provided in this Convention, the provisions of this Convention apply, in relation to each Contracting Party: (a) In the case of components of biological diversity, in areas within the limits of its national jurisdiction” (emphasis added). These national sovereign rights simply cannot apply to GR outside the national territory. Thus, the CBD regulates access, not ownership.

8. Once this is understood, several difficulties are avoided. It implies that we are concerned with specific physical samples of GR, not classes such as species or genera. In particular, if the CBD were thought to confer ownership of GR genera, species or varieties, what would be the position of different countries possessing the same (or very similar) GR? What would be the position of progeny of the GR (identical, slightly different or considerably different)? Again, what happens to the sample of GR after it leaves the territory is no longer of concern. The recipient who has been given access is bound by any mutually agreed terms – which may also govern how the recipient deals with progeny or modifications of the GR. But these are requirements imposed by contract, which do not affect third parties. Also, it greatly simplifies matters for would-be researchers. The crucial question for them becomes, Where did I access this sample of GR? This is a much easier question to answer than, Where did this GR originate?

9. The Regulation avoids falling into the 'ownership' error. Recital 6 says “The [CBD] Convention recognises that States have sovereign rights over natural resources found within their jurisdiction and the authority to determine access to their genetic resources.” (emphasis added). Some have interpreted 'found' to mean 'originally found', so that a GR that originates (is found for the first time) in a particular country ever afterwards is under the control of that country. The correct interpretation, as set out above, is that sovereign rights apply only to GR within the jurisdiction and enable the country to control access.

10. To reiterate: Nagoya and the CBD do not give countries ownership rights over materials 'found' within their jurisdiction. What they have are rights to control access. The CBD, in Article 15, specifies only two classes of GR to which a country is to give access: a) GR for which that country is a 'country of origin'; b) GR which has been acquired by that country 'in accordance with this Convention'. A country may assert rights to control access to other GR within its borders under broader rules of sovereignty, but these do not derive from the CBD. It cannot be an objective of the Regulation to enforce such broader rights.

11. Now the EU has taken the view that breaches of CBD access laws are sufficiently serious that special measures are required to support them. Accordingly it has brought in the Regulation to support such laws. But in applying the Regulation it remains vital to remember that its objective is to support the CBD and Nagoya – and that these conventions regulate access and not ownership. The means adopted are to require researchers accessing GR in a member country of Nagoya to use 'due diligence' to ensure that the GR has not been accessed illegally. This is a requirement to prove (or at least make a reasonable case for) a negative. And the relevant facts (and even laws) will often be obscure. Showing 'due diligence' may be no light matter. There has been much noise about 'illegal access' – and the harm caused by this – but relatively few convincing instances have been documented. The likely benefit from the new rules seems completely disproportionate to the burden put on researchers. And some of the research that will be hindered (or prevented) will be urgent and critical. We therefore urge the Government to seek the greatest possible flexibility and lightness of touch in enforcing the Regulation. The Government should recognise that most researchers with GR are seeking solutions that will benefit society: obstacles to their research must be kept to the necessary minimum. General Comment

12. We are somewhat bemused by the approach of the Consultation. The idea that permission is required to do any 'research' on a biological material to which one has legal title is completely new to many people. It will take some getting used to. The Regulation imposes on Member States the duty to 'help stakeholders and interested parties to understand their obligations' (Article 13). This, in our view, should be the priority for the Government – rather than elaborate details about enforcement and penalties for breach, to which the Consultation devotes so much emphasis. 'Users' need much fuller explanation of how the Regulation is expected to work, and will expect detailed and authoritative briefing as to what they can and cannot do – as well as clarification (to the extent possible) of any uncertainties. Definitions

13. To begin with, explanation is required of several of the terms used in the Regulation – some are explicitly defined, others not. Thus, 'access' is defined as “...the acquisition of genetic resources ... in a Party to the Nagoya Protocol” (Regulation Article 3.3). We think it fairly clear that this can only mean physical acquisition – obtaining possession of material comprising genetic resources. Merely acquiring information about a GR is not 'access'. This point is important because concerns have been expressed that any use of published DNA sequence data from an organism (without receiving samples) might be considered 'access'. That would be quite unreasonable: and severely impede the work of molecular biologists. But it would be helpful to have this interpretation confirmed.

14. A further point is that the definition of 'access' is unqualified by intention. This gives clarity. 'Access' does not depend on determining the intention of the recipient at the time of access. This does not dispose of all difficulties. But those who receive GR are not subject to the Regulation if they do not propose to do research on it (see para 15 below). For example, the hypothetical supermarket 'Foodco' may import GR in the form of produce (fruit and vegetables) from South America and sell it for consumption without any obligation to seek prior permission or keep records under Article 4, or make declarations under Article 7. This access is legal, so presumably Foodco's customers' access – for any purpose - is also legal: but this needs to be clarified.

15. Other definitions worth commenting on include: 'user': defined as “a natural or legal person that utilises genetic resources...” (Art.3.4) This would be a fairly straightforward definition, where it not for the accompanying definition of 'utilisation of genetic resources' (which presumably also modifies the meaning of 'utilises'). “‘utilisation of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the [CBD] Convention”. Accordingly a 'user' means one who conducts R&D on GR – not one who only sells or consumes it (surprisingly, this special meaning of 'user' is nowhere explained in the Consultation, which may confuse or mislead some readers). ‘illegally accessed genetic resources’ are defined as “genetic resources ... which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent”. This is poor drafting, since if read literally it would suggest that all research on GR not so accessed was illegal – it must be understood as if 'were not accessed in accordance with' were replaced by 'were accessed in breach of''. However, the misleading wording is of little importance, because the Regulation does not use the defined phrase anywhere else.

16. Several important terms used in the Regulation are not explicitly defined (in the Regulation at least). These include “country of origin” and “provider country”. These are however defined in the CBD (Article 2), as follows: “'Country of origin of genetic resources' means the country which possesses those genetic resources in in-situ conditions.” “'Country providing genetic resources' means the country supplying genetic resources collected from in-situ sources, including populations of both wild and domesticated species, or taken from ex-situ sources, which may or may not have originated in that country.” From this definition we take it that the 'provider country' (which we assume to be synonymous with 'country providing genetic resources') is the country in which, or directly from which, the user receives GR. For GR collected from in situ sources, the 'provider country' is the 'country of origin' – otherwise determining the 'country of origin' is an exercise left to the 'user' – not necessarily an easy one. 'in situ' is also defined in the CBD, but not in such a way as to make it clear whether crops being cultivated in a country are to be considered as 'in situ'. This should be clarified – it will affect the status of many commercially important resources.

17. An important definition that is completely missing is that of 'research'. What kinds of research with or on GR is included? All kinds? Does it include research not related to the GR as a genetic resource? One examples of a severe potential difficulty will be given later. Obligations

18. With the aid of these definitions, we can now explore how the Regulation works. The first requirements of the Regulation are those imposed by Article 4. They are imposed only on 'users' (researchers). Article 4.1 provides: “Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements,...” (emphasis added). Firstly we suppose that the requirement is satisfied if there is no such applicable legislation or regulation – again, it would be clearer if the Article forbade access in breach of such requirements. Secondly we note the use of the passive voice: 'have been accessed'. It is not sufficient for the user to access the resources legally – he must do his best to ensure that nobody else has either. Presumably “nobody else” here would mean any predecessor in title to the GR (or to GR from which the accessed GR is descended?). If similar GR has been accessed illegally by an independent third party, this cannot be relevant (see para 8 above). But the main difficulty is what is to be understood by 'due diligence'. No attempt is made to define this (or even clarify it) in the Regulation. It seems that the Commission will consult and draw up codes of 'best practice' which may vary widely according to field of study or industry. No criteria are provided by which to judge whether 'diligence' is 'due'. Even 'best practice' is not necessarily enough. Article 8 visualises that following codes of 'best practice' may not always satisfy 'due diligence' and provides that in such cases the codes are to be changed. Without criteria, 'due diligence' requirements may appear quite arbitrary. It is in any event surprising that 'best practice' should be ranked inferior to 'due diligence'. Much more explanation is required about the degree of diligence necessary and how 'best practices' will be compiled.

19. While 'due diligence' broadly is not defined, various actions required as a necessary part of it are specified in Art. 4.3. Users must 'seek, keep and transfer to subsequent users' either 'the internationally-recognised certificate of compliance' (Art 4.3(a)) or (if that is not available) date and place of access of GR, a description of it, the direct source, subsequent users, and whether or not there are ABS commitments, with details if there are. 'Subsequent users' needs clarifying. We are unclear how identifying 'subsequent users' can form part of 'due diligence'. 'Due diligence' is to ensure GR 'has been accessed' legally – how can what has happened after access be relevant? Leaving that problem on one side, is it right to presume that the 'subsequent users' referred to are only those who have received the GR from the original 'user'? We suppose that no obligation to know about or report on independent users is imposed. Such users (whether connected or independent) have in any case the obligation to carry out their own 'due diligence'. One can also conceive circumstances in which a 'subsequent user' might receive GR from the original user indirectly. Suppose research on the GR results in a product incorporating it. This is sold on the open market, to a consumer (not a 'user'). A third party obtains it from the consumer, and begins research, becoming a 'user'. Such a 'user' may not become known to the original user, who will not then be able to report on him or to provide him with the required information. Essential Research

20. We revert to a difficulty caused by the definition of 'access' and the failure to define 'research'. As noted above, Foodco may import produce for consumption without Nagoya permissions. While there is no formal exclusion of commodities in Nagoya, it was always said in negotiations that the treaty was not intended to apply to commodities. However, suppose a health scare, on bacterial contamination or pesticide residues, for example. In such a situation, Foodco will wish (or may be required by public health authorities) to analyse the imported produce for health reasons. Must they await permission from 'countries of origin'? Or is research of this kind not covered by Nagoya? We hope it is the latter: but if so, guidance is urgently needed as to how to tell permitted research from Nagoya-controlled research. In the case of a bacterial infection of produce, would the consent of the country from which the produce was imported be required for research on the bacteria? Or could it properly be argued that the 'country of origin' of the bacteria was the UK (since the product is the 'natural habitat' of the bacteria, and accordingly the UK possesses the bacteria in 'in situ' conditions – see CBD Article 2, Definitions). More generally, a definition of 'research' is required, so that consumers know what tests (if any) they can do on 'commodities' or materials intended for consumption to satisfy themselves that the goods are fit for their intended purpose. These are important practical questions that need clear answers.

21. Situations more serious than Foodco's can easily arise. There is no general provision for any abrogation of the Regulation in case of necessity. This appears to have been deliberate. There is a specific exception in Article 4.8 for pathogens deemed likely to constitute a serious hazard to public health. But the exception is only to allow deferring of the procedures prescribed for a maximum of three months! If this date is missed, research must stop. This beggars belief. Suppose the ebola virus comes from Africa to Europe. Thousands are infected (with most distressing symptoms and a death rate of up to 90%). It is not clear which is the 'country of origin' (somewhere in Africa, but where?). Or the country claiming to be 'country of origin' is not immediately willing to agree terms. If this isn't sorted out in three months, research has to stop? Will it?

22. Foodco's situation is a specific case of a more general problem. What is the position of a person who 'accesses' a resource, without intending to do research on it, and subsequently changes his mind? 'Access' has already taken place. It is too late to obtain Prior Informed Consent to such access. Can Subsequent Informed Consent be sufficient under the Regulation? Or is it not needed? Enforcement

23. We now turn to this question, on which, as we say above, we feel the Consultation concentrates disproportionately. The first priority of the Government should be to educate users (and others) in what the Regulation requires them to do, and not do. Enforcement, though we understand it is an obligation, is a lower priority. That said, we applaud the broad approach of the Consultation, proposing a collaborative approach to enforcement and compliance. That must be right. We would however like to see this approach written into the legislation, so that it is not liable to change with changes in the political climate. The Regulation itself has largely succeeded on the premise (which we consider very dubious) that the Nagoya Protocol 'helps the environment' . A future administration might accordingly conclude that firmer enforcement would help the environment even more. We would like to guard against this possibility by making the approach explicit in the legislation.

24. We see no objection to making the NMO the body charged with enforcement of the Regulation. It helps that they have experience of administering 'best practice' schemes, as applied to timber sourcing. We hope they will be able to use this profitably in fitting such schemes to the much broader range of circumstances that will arise out of the Regulation.

25. Generally, we question the proposals for enforcement. Article 11 calls for penalties to be “effective, proportionate and dissuasive”. In our view, the proposals are not proportionate. Nagoya (we believe) is primarily concerned with remedying economic wrongs – failure to share benefits equitably. It does not give 'provider countries' anything corresponding to a 'moral right' in the resources they control. Research carried out in breach of the Protocol will generally lead to economic loss to the 'provider country' only if a product is commercialised as a result. Where no commercial product arises, sharing the results of research should be sufficient restitution. Any penalties should be small. If a commercial product results, a penalty may be bigger, and proportional to the volume of product sold. Future sales will depend on agreement with the 'provider country'.

26. In these circumstances, we applaud the proposals to rely as far as possible on civil sanctions. It is disappointing, therefore, that these are immediately followed by proposals to create four new criminal offences! We believe no new offence need be created. Reasonable sanctions, if ignored, could be enforced by Court order - in proceedings which would give the offender the opportunity of testing the legality and reasonableness of the sanction, and allow appropriate penalties on recalcitrant respondents. The appropriate Court would be the High Court (perhaps the Intellectual Property Enterprise Court, which is set up to deal with scientific disputes). We don't think administrative tribunals should be involved. STOP notices, which have the effect of injunctions, should only be issued by order of a Court, normally after a hearing, and be subject to the same equitable principles (including balance of convenience) as injunctions. A detail on Compliance Notices – care should be taken not to impose terms which are impossible to meet. Thus a researcher who has already started research is too late to acquire Prior Informed Consent – nor can he compel the 'provider country' to agree MAT.

27. The figure of £250,000 for maximum civil penalty seems to us far too high, at least for infringements which do not lead to a commercial product. A maximum figure sets the range of penalties, so that modest breaches will be penalised in proportion. We think the typical figure for a modest 'research breach' should be very much lower – say £2000 or so. The maximum might then be set at £10,000. For breaches in which the research has led to a commercial product, penalties could properly be more substantial. They should be linked to the success of the product – with (say) a maximum of 5% on past sales. Future sales (if any) would of course have to be negotiated between the 'provider country' and the user – on 'mutually agreed terms'.

28. This is a completely new area. Complaints of 'biopiracy' by British firms have been rarely heard. We are not aware and do not believe that there are current causes of significant complaint. This is supported by the investigations of Oldham et al carried out for DEFRA and the UK Intellectual Property Office, currently circulating in draft. Nor are these likely to increase before the Regulation comes into force. We think criminal sanctions are totally inappropriate. Penalties should be civil sanctions. These will be quite sufficiently effective and dissuasive. If (what seems to us unlikely) five years (say) of experience suggests the need, criminal sanctions could be introduced at that stage. We do not think NME officials should have access to inspect premises unannounced without a court order (as is the practice with Anton Piller orders). Normally and preferably compliance checks should be limited to an obligation to provide relevant information on written request from the NMO. Provision of significantly inaccurate information (deliberately or carelessly) could probably incur criminal sanctions under existing legislation. Were other criminal sanctions in question, the duty to co-operate with the authorities would need to be balanced against the right not to incriminate oneself. Against any sanctions, civil or criminal, there should be a defence of Necessity (see para 21 above).

29. We note that DEFRA has no current intention to issue Certificates of Origin for materials accessed in UK. We ask that this should be reconsidered. There is no obligation for the UK to assert its Nagoya rights over access to GR if it does not wish to. However, given the notion that poorer 'provider countries' are going to benefit substantially from their genetic resource rights (and if this is not correct, then the whole Nagoya concept is a major waste of effort) it seems at best cavalier (and at worst a breach of duty) for the UK to ignore the profits that it would be entitled to from exploitation of its own biodiversity. However that may be, the issue of UK Certificates would be a substantial convenience for 'users'. A UK Certificate for UK-accessed GR would save 'users' from burdensome record-keeping and provide reassurance against unjust accusations of Nagoya breaches. Further, such Certificates may increasingly be required by inventors filing patent applications abroad.

30. We re-iterate our concern about the difficulties imposed by the Regulation on researchers. Hitherto research on a genetic resource has been presumptively legal. The Regulation changes this: when it comes into force, such research will be presumptively illegal without permission from the 'provider country'. Which is the provider country and whether it has the right (or is prepared to) give permission for research, will often be unclear. Many potential researchers, faced with such uncertainties, will simply abandon their research plans. This will sadly inhibit UK research on genetic resources. One very probable result is that such research – and such researchers – will migrate to the USA. The USA is not a member of the CBD, has not signed Nagoya and has no plans to do so. This could be exceptionally damaging to the UK's research base.

31. In response to the specific questions posed in the Consultation, we summarise as follows:

31.1. Do you think this is an effective way to meet the UK’s remaining obligations under the Nagoya Protocol? Do you have any alternative proposals? Broadly, as set out in more detail above, we think what is proposed could be considerably improved. In particular, we would like to see much more thought about and emphasis on educating 'users' in their responsibilities.

31.2. Are you content with the proposed due diligence process? Do you foresee any difficulties that you or other users may face in meeting their obligations? We are not content with the proposals. We are particularly concerned about 'due diligence', because no criteria are set which it will need to meet. This is far too vague. 'Best practices' are a good idea in principle, but are likely to vary widely between technical areas, and where research is undertaken in a new area, the absence of 'due diligence' criteria will be particularly inconvenient. And it is confusing that even following 'best practices' will not necessarily satisfy the obligation of 'due diligence'. As regards difficulties, we are daunted by the requirements that our clients may need to fulfil. Collecting GR in situ in countries which do not assert Nagoya rights will be relatively straightforward. Any other 'access' is going to be problematic. Determining whether 'users' need rights to access GR and, if so, who is empowered to give them seems to us likely to be so difficult as dangerously to inhibit useful research.

31.3. Are you content with the proposed set of limited powers to be given to the NMO? No. See our comments in paragraphs 23-28 above.

31.4. Do you think that the mix of criminal and civil penalties outlined here is a proportionate means for the UK to enforce the Nagoya Protocol? No. See our comments in paragraphs 26 and 28 above. We consider criminal sanctions totally unnecessary and undesirable.

31.5. Should there be a cap on Variable Monetary Penalties? If so, should the cap be set at £250,000? What other level would you consider appropriate? Not necessarily. Any arbitrary cap should be much lower. See our comments in paragraph 27 above.

31.6. Are you satisfied with the mix of civil sanctions set out above? If not, how could the enforcement mix be improved? See our comments in paragraphs 23-28 above.

31.7. Do you agree with the proposed procedures for issuing notices of intent, Compliance Notices, Stop Notices and VMPs? If not, what would you change? No. See generally paragraphs 23-28 above. In particular, we think Stop Notices should only be issued by the High Court.

31.8. Are you satisfied with the proposed procedures for appeals? If not, in what way could they be improved? No. See our proposals for enforcement via the High Court (para 26). Appeals from the High Court can then follow the ordinary course.

31.9. Are there specific elements of the EU Regulation or Protocol on which you or your sector would seek particular training or guidance? We - and our clients - need more training and guidance on very many aspects of the proposals. Much more emphasis should be given to this, if GR research is to continue at a reasonable level. One particular need is for a clear definition of 'research'. We understand that the Government cannot advise in detail on other countries' laws, but it must do as much as it can. As a minimum, it should keep an up-to-date list of countries who enforce Nagoya access rights.

31.10. What costs and/or benefits do you estimate you or your organisation will incur from the Regulation? Can you provide numerical figures? Some financial benefits will come to our members from work in advising clients of their obligations under the Regulation and how best to meet them. Some work may come from helping to negotiate MAT between 'users' and 'provider countries'. Losses are expected as a result of clients doing less research and in consequence filing fewer patent applications. We expect many lines of research leading to potential patentable inventions to be abandoned - because of unclarity about who controls rights to access the relevant GR. We currently expect financial losses by our members to outweigh gains.

We are much more concerned, however, about other losses – the opportunities that will be missed – and the damage to the UK as a whole - as a result of research being abandoned or curtailed. Sometimes this may be through lack of understanding or fears (justified or unjustified) of inordinate penalties. While large pharmaceutical companies may be able to do the necessary 'due diligence' and to negotiate PIC and MAT, or alternatively to move their research to a non-Nagoya country, we are fearful that smaller biotechnology companies – as well as academics - will find their research in jeopardy from the proposals. The CBD is supposed to encourage research on GR, not impede it. Benefits from GR research can vastly enrich the whole human race, not just providers and researchers.

Roger Burt, CIPA President, 17 April 2014.