Category Archives: Legal policy

Tell us what Brexit means, then IP laws can be reviewed

busesWhen Brexit happens, what will happen to existing UK IP laws? And what should the UK government’s proposals be in the field of IP law, in the forthcoming Brexit negotiations?

As with so many Brexit questions, the UK government needs to start deciding on its policy and strategy for Brexit, before the IP profession can sensibly suggest IP-specific proposals. One of these policy decisions is what is to happen to existing UK laws that are influenced by EU laws, immediately following the UK’s formal leaving of the EU. Many current IP laws in the UK consist of, or are affected by EU laws; very little is unique to the UK.

IP Draughts assumes that the UK government will have to pass UK legislation to take effect immediately following our formal leaving of the EU, and that there will be insufficient time before Brexit, to draw up individual measures covering every area that is currently influenced by EU laws. In other words there will need to be some kind of sweeping, interim master-law that defines the new legal regime, probably in combination with numerous exceptions and qualifications that are considered sufficiently urgent to be dealt with at the time of Brexit. Once this new legal regime in place, Parliament can take its time to develop new laws and revise existing laws across the policy areas that may be thought suitable for a distinctive UK approach.

If that is right, then it would be helpful to clarify how the new master-law will work. For instance (and some of the following questions overlap):

  • Should we assume that all existing, national UK laws that are derived from EU laws (e.g. are designed to implement an EU directive) will remain in place immediately following the UK’s formal withdrawal from the EU? For example, the Data Protection Act 1998 currently falls into this category, as it is a UK law that implements an EU directive. However, this may not be a good example, as the Act may be repealed and replaced before Brexit by the new General Data Protection Regulation (GDPR), which is due to come into effect automatically throughout the EU (ie without the need for national legislation) in 2018.
  • Should we assume that all EU laws that currently have direct effect in the UK will automatically cease to have effect on Brexit, or will the UK government introduce some kind of holding measure to continue them all in force as purely national UK laws, unless otherwise stated? If the GDPR is introduced before Brexit, it will fall into this category.
  • In the area of laws affecting international trade (a category that may be thought to include IP laws), should we assume that, as a default position, immediately following Brexit UK laws will be aligned as closely as possible with current EU laws, with individual exceptions where it is felt to be in UK interests to have them? Or will the opposite policy position be taken? Or will every law be looked at on a case-by-case basis before Brexit?
  • cjeuShould we assume that there will be a strong presumption against allowing any EU jurisdiction (eg by the CJEU) to continue in the UK in any field post-Brexit? Or will a more sophisticated and nuanced position be taken, eg distinguishing between EU controls over areas of major political interest, such as immigration, and areas of international trade that don’t affect core political concerns? This may seem like a theoretical question, but consider the case of UK participation in the Unified Patent Convention. If it is possible for the UK to participate post-Brexit, but it is a condition of continued UK participation that the CJEU has ultimate supervisory authority (as CJEU Opinion 1/09 suggests – see this recent opinion by Richard Gordon QC), will the UK government be unable to stomach this ‘loss of sovereignty’ or will it be treated like any other area where, in the interests of UK trade, the UK agrees to supranational authority over UK activities (as may be the case with certain international trade treaties that give authority to the World Trade Organisation). Will the UK government be brave enough to recognise the valuable benefits to the UK of this (minor) loss of sovereignty, even it risks giving the Daily Mail ammunition to write hostile articles? IP Draughts has considerable doubts on this issue, given the recent rhetoric of senior government ministers such as the Secretary of State for International Trade.

In IP Draughts’ view, it is in the UK’s interests for future UK IP laws, and other laws affecting high-tech business activities (eg the regulation of pharmaceuticals, data protection laws, recognition of judgments) to be aligned as closely as possible with those in the rest of the EU. Ideally, there should be ongoing, formal cooperation between the UK and the EU in these areas, so as to ensure such continuing alignment.

steerBut it has yet to be seen what the UK government’s approach to trade laws, including IP, will be following Brexit. A great deal of work is being done by IP practitioners, through various technical committees, to consider the detail of what should happen to IP laws. But until we get a steer from government on their overall approach, and how they plan to deal with IP and trade laws, it is difficult to devise a strategy for negotiating the best outcome with the various actors (including governments, as well as industry and IP professionals, across the EU). This is not purely a matter for governments to negotiate. IP professionals will want to discuss these matters with their opposite numbers in other EU countries. as well as representatives of industry, and hopefully get their support, and their advocacy to their national governments, on areas of common interest. In an area as technical as IP laws, IP Draughts hopes that UK and EU governments will seek advice from specialists in the field.

 

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Legal drafting issues in medical research

biobankIP Draughts has been reviewing a large number of publicly-accessible documents used in medical research, particularly in the context of what are variously known as tissue libraries or biobanks. In other words, collections of materials taken from patients and intended for use in research. The materials might include body tissue, cancerous cells, or blood. The research might lead to the development  of diagnostic products or therapies for human diseases and conditions.

The documents currently on IP Draughts’ desk include patient consent forms, information leaflets, material transfer agreements, and policy guidance notes. Reading these documents, it is striking how much variation there is in the language used to convey similar ideas, and how difficult it seems to be to communicate clearly and accurately.

IP Draughts doesn’t underestimate how complex the task is. The drafter needs (but often seems to lack) a wide range of skills, including:

  • Regulation. How to comply with and explain complex laws and regulations, such as the Human Tissue Act and Data Protection Act. Often there are several layers of regulation, each with their own vocabulary, including those applying to human tissue, associated data, data protection and medical ethics.
  • Contract drafting. How to draft documents in a legally accurate way. For example, in identifying the parties to an MTA. Organisations such as  “the Loamshire BioRepository” (to anonymise the name in an MTA in front of IP Draughts) doesn’t exist as a legal entity, and is simply a convenient name for a collaboration between Loamshire University and Loamshire Hospital NHS Trust. Referring to the Biorepository as the provider of the materials is unclear. At the end of the document, it is unclear whether the person asking for the materials is an individual researcher or an institution. Failing to identify the parties to a contract is a very basic mistake. In the same document, the drafter clearly doesn’t understand the conventions on using defined terms; he defines the “Material”, then uses the expression ‘Material’ with pointless and weird single inverted commas.
  • Science. How to communicate with researchers, whose focus is likely to be mainly on their scientific projects, and less on the details of compliance with legislation.
  • Donors. How to explain, at a level suitable for the general population, the nuances of the permissions being sought – eg the range of research in which the human materials will be used, the right of the person to withdraw consent, why individual-related information on the outcome of the research will not be provided (it should be done by the patient’s doctor, not by a research team; and anyway, if the research has been anonymised, the researchers won’t know the identity of the patient, etc)
  • Communicating at a time of grief. In the case of material to be taken from a corpse, how to communicate with grieving relatives who are being asked for permission to use the body of a recently-deceased person for medical research, or to confirm their consent to instructions given by the deceased before his or her death

bodyReading through a selection of documents, IP Draughts is left feeling that the drafting of documents within a complex regulatory regime should be a multi-disciplinary team effort, in which the best communicators among doctors, nurses, researchers, regulatory experts and lawyers should be engaged. Instead, the drafting seems often to be left to someone to ‘muddle through’ as best they can.

One of the areas where these issues come up is in relation to IP and property issues arising from the use of materials in research. These issues arise at several levels:

  1. As a matter of public policy and law, it may not be possible for there to be property in body parts, though there seem to be some exceptions to this principle. Similarly under the EU Biotechnology Directive, some aspects of the human body are not patentable. Therefore, referring to a biobank as owning materials, or owning the IP in materials, may or may not be legally meaningful.
  2. Linked to the above points is whether the patient can claim any financial or other interest in, or control over, the exploitation of products derived from research that made use of their materials. If consent forms mention this issue at all, they vary widely in how they cover it.
  3. Should the biobank, in its relationship with the researcher who takes material from the biobank, claim to own those materials? Some do and some don’t. A policy document issue by the UK National Cancer Intelligence Network in June 2009, quoting a recommendation of the Confederation of Cancer Biobanks, suggests that biobanks should waive their IP rights in the materials that they supply to researchers.

noIP is just one of dozens of legal, practical and policy issues that are typically addressed in the documents. It is difficult to know how best to deal with these issues as a researcher or the employer of a researcher. Should one take the terms on offer or try to negotiate them, if only to remove glaring inconsistencies and inappropriate terms? It seems that some biobanks refuse to negotiate the terms of their MTAs, no matter how badly drafted they may be.

Rather than spend a time and money negotiating terms in individual cases, shouldn’t the sector be developing some standard contracts, as has been done for university research contracts (the Lambert agreements) and for clinical trial agreements in NHS hospitals? Although neither of these examples of standard contracts is perfect, at least they provide a way of reducing negotiation time.

 

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Why professional values matter

poppyEvery few years, political pressure is applied to the professions, to make them more like ordinary people, or to provide services in a similar way to high-street retailers, or to accept external regulation and complaints-handling, or to admit non-graduates to their ranks, or to allow external ownership by people who are not part of the profession, or to remove any remaining monopoly rights they may have in favour of more competition from unlicensed competitors.

Some of these pressures contradict one another. Increasing the burden of regulation on a profession, while at the same time allowing unregulated, non-professionals to provide the same services, is intellectually incoherent. We are pulled in one direction by a belief in open markets, and in another direction by a belief in consumer protection.

There is also a contradiction between professions. The English education minister has recently referred to the importance of teachers regulating themselves; at the same time, the government is proposing independent regulation for solicitors. The nursing profession is moving to an all-graduate entry; at the same time, pressure is being applied to solicitors to admit non-graduates.

Some of the pressures may be contradictory, but the overall theme is clear. Over time, professionals are losing control over many aspects of their professional life, including entry to the profession, training, qualification, rules of conduct, the structure of firms, the terms of their relationships with clients, complaints handling, and expulsion of defaulting members.

In the case of solicitors, the process of emasculation has been a gradual one. First, the profession delegates control over these matters to a ring-fenced subsidiary, with a minority of external lay Board members. The subsidiary employs professional regulators who look at the profession from the outside, and apply their own professional values to regulation, rather than those of the profession that they are regulating. Gradually, they change the rules governing the profession, to make them more like laws than statements of ethical principle.

let goA few years later, the number of lay Board members is increased so that they form a majority, and a lay Chair is appointed. The regulatory body becomes more remote from its parent. Some of the regulations for solicitors seem designed to reduce the SRA’s workload rather than being proper matters for regulation, eg requiring solicitors to run a viable business. Finally, the Chair leads a move to make the regulatory body completely independent from its former parent.

This is what is happening with the solicitors’ profession in England and Wales. In IP Draughts’ view it is the wrong direction for solicitors to take. If we are forced by the government to accept external regulation, so be it. But the model of external regulation should not be based on the self-regulatory model. Self-regulation covers many aspects, including the values that the profession seeks to embody.

familyWhen the Solicitors Regulation Authority was formed, all aspects of the solicitors’ profession, other than representation, were hived off into the SRA, including training, ethical conduct and insurance obligations. This made sense when the SRA was still part of the Law Society family, but in hindsight it was a dangerous route to take. If the SRA is to become completely independent, as the current Chair has recently suggested, then its role should be strictly limited to those aspects that need to be independent, eg misconduct and complaints handling.

This will allow a level, competitive playing field between solicitors and other legal service providers who are bound by the same regulations. At the same time, solicitor should be allowed to impose higher standards on their members, and to offer an upmarket service to clients based on those higher, common standards.

To take a few examples, solicitors have stricter rules than some other service providers in areas such as handling conflicts of interest, acting in the best interests of the client, compulsory insurance (and the terms of that insurance, which seem to annoy some underwriters), and so on.  These and other areas should be under the control of the profession, as part of its USP, rather than a matter for general regulation.

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Interested in influencing IP laws and policies?

law societyAre you interested in influencing the development of future IP legislation and policies in the UK, EU and internationally, as a member of a technical committee of lawyers in England and Wales?

The Law Society of England and Wales (LSEW) has announced that it has vacancies for membership of some of its committees, including its Intellectual Property Law Committee (IPLC). (Mark Anderson is the current chairman of the IPLC.)

The IPLC has an interesting and diverse workload. Recent projects of note include the Unitary Patent, the draft Bill to revise UK law on making threats of IP infringements, a consultation on the EU Enforcement Directive, and the European Commission’s digital rights agenda. As well as meeting 4 times per year, members of the IPLC volunteer to work on responses to consultations and proposals for draft legislation.

Members of the IPLC receive a small allowance and are entitled to claim certain travel costs.

The IPLC has four vacancies. Details of the vacancies (as well as the vacancies for the other committees), and how to apply, can be found here. We are looking for good people, irrespective of background. On this occasion, to balance the experience of IPLC members, we are particularly interested in candidates who are:

  • digital copyright specialists,
  • trade secret specialists,

Including candidates who are:

  • in-house lawyers,
  • City solicitors (and perhaps willing to act as a liaison with the City of London Law Society’s IP group), or
  • Regional solicitors

But even if you don’t fit into these categories, we have 4 vacancies so you shouldn’t be put off from applying if you have the technical knowledge and skills to contribute to the IPLC’s work.

If you are an IP solicitor in England and Wales and this type of work interests you, please consider making an application. The closing date for applications is 12.00 noon on 20 April 2016.  If you would like to discuss any aspect, please contact Mark at msa@andlaw.eu or on 01865 858 878.

 

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