Examination of Witnesses (Questions 860
- 879)
TUESDAY 22 APRIL 2008
Mr Philippe Petit and Mr Antony Taubman
Q860 Baroness Whitaker:
This is to protect the ownership of a certain plant growing in
an area that might be used for a medicinal purpose? Is it that
sort of thing?
Mr Taubman: That kind of thing. It is more the
knowledge about the distinctive medical uses of the plant than
just the plant itself.
Q861 Baroness Whitaker:
The process?
Mr Taubman: There are concerns that knowledge
may have been used inequitably and that there is insufficient
recognition of the community that has nurtured this knowledge
in the first place. That is the nature of the work. In terms of
the process it is entirely driven by that concern and perspective.
When you think of accreditation and active involvement, we have
indigenous communities from across the globe now taking part in
our work. One aspect is the formal process of accreditation, but
the other aspect is concern about effective participation. We
were told again and again that indigenous communities particularly
did not have the means, the resources, to come to a meeting in
Geneva. So a fund has been set up specifically to support their
participation here. I must say, that has really changed the flavour
of the work. Apart from the formal accreditation side, it is a
matter of their active participation as well.
Q862 Baroness Whitaker:
That is very helpful. Would you nevertheless say that the majority
of non-governmental organisations which are there at your meetings
still tend to be trade and industry? Or do you think it is evenly
balanced now? Most of these, from a very quick look, look to me
to be trade and industry.
Mr Petit: It is more a matter of impression.
I will give you my impression. In the debates, those who actively
take part are in favour of the defence of human rights, they are
active, they are militant, they defend the interests of developing
countries and humanitarian causes. Others are present, it is difficult
to say in which proportion, it is difficult to qualify them sometimes,
but they are not so active, not so vocal. I think they may have
other means of lobbying. They follow the debates but do not intervene
that much.
Q863 Baroness Whitaker:
There are two developments which also fit in with your organisational
role. I see that the new WIPO Committee on Development and Intellectual
Property, according to my briefing, had its first meeting on implementation
in March. I would like to know if that will usher in any changes
to your activity. I also understand that you are soon going to
have an election for a new Director-General. Do you anticipate
changes in regime? Are we going to hear some more good news now?
Mr Petit: In fact, there is a link between your
two questions because the organisation for a short period is in
a situation of transition between the former direction and the
new one. A new Director-General will be elected soon. This has
a consequence on the Development Agenda. The Development Agenda
was adopted unanimously by the General Assembly of the organisation
last September, but at the same time there was a crisis linked
with the leadership of the organisation. The Development Agenda
went somewhat unnoticed because everyone was concerned with the
crisis and not so much with the Development Agenda. I think one
of the first responsibilities of a new Director-General will be
to promote this Development Agenda, which has remained almost
unnoticed since last September, and then to implement it. The
essential idea of the Development Agenda is not only to approve
the 45 recommendations which were negotiated between the Member
States but to have a global approach to development in all the
activities of the organisation, a bit like the Doha Round has
been baptized the highest development round in WTO. It is a global
approach for us to put the accent on the fact that intellectual
property is not an end in itself. It's end is to promote innovation
and creation, which is as important for developing countries as
it is for industrialised countries and is a factor of growth and
development. This is the main idea of the Development Agenda,
that it should inspire all the activities of the organisation
and not only implement practically each one of the 45 recommendations.
Q864 Baroness Whitaker:
I understand, it will be a sort of mission statement. What might
be the practical outcome in the way you go about your business
or your priorities or activities?
Mr Taubman: I can give two very recent examples.
Two weeks ago I was in India, where the WTO was holding a regional
workshop on implementing TRIPS in the interests of developing
countries, so a strong focus of that was not the legalities in
isolation but the practicalities of giving effect to the flexibilities
that we covered earlier. Our role was to provide technical support,
advice, input on a range of issues from access to medicines through
to the recognition of indigenous knowledge, for example. That
is routine. It does not get reported because it is so much embedded
in what we do. As a second example, last week I was in South Africa
working with the Indigenous Knowledge Systems Policy Group, who
are looking at practical ways of building on the indigenous knowledge
of South African communities and building that into their research
and development systems in the pharmaceutical area. This program
combines the goal of greater recognition, in a legal sense, of
traditional knowledge with meeting the pressing health needs of
the community. Again, it was entirely practical in character but
was infused by the kind of policy settings espoused by the WIPO
Development Agenda, a focus on social and economic development
and a much more flexible look at what intellectual property is
and does and how to apply it to real needs of developing countries.
It is difficult to report on that globally because it is so infused
in what we do. These two examples were literally in the last three
weeks.
Q865 Baroness Whitaker:
If I could ask one final question to try and clarify this. If
you have a local community, quite poor, which has some useful
plant medicine which they prepare and use, and a big company from
outside wants to come in and exploit this a little bit more commercially
and not deal in the local community with a fair deal, whose side
would you be on? Would you be assisting the local community to
protect its quasi-ownership, although it is not a very scientific
one? Or would you be protecting the sophisticated scientific exploiter
for the common good of this? How would you operate in that circumstance
if you were called in?
Mr Taubman: You can look at it on two levels.
The first is at the political level. Plainly, those who are in
need of support from a UN agency, those who are lacking in resources,
lacking in practical legal know-how, are the ones in need. The
important point is that we are directed by the Member State concerned,
we are not a free agent here. The Member State concerned would
be guiding us as to what their overall needs were.
Q866 Baroness Whitaker:
Which of these two alternatives do you prefer? The national government
might prefer the big company, they might get themselves a good
deal out of that.
Mr Taubman: At the practical level, it really
depends on what the needs are. At the legal policy level, I would
offer maybe a slightly casuistic response. I genuinely believe
it is a matter of developing beneficial partnerships, because
it has been shown not to work if there is a zero sum winner-takes-all
approach. The problem is that the needs, the cultures, the ways
of viewing the world, can be so disparate between potential partners.
One of the difficulties is to see these kinds of complex partnerships
squeezed into the question of what is a fair royalty rate. Indigenous
communities can resent that approach because it suggests they
are reducing what may be sacred traditional knowledge to a kind
of cash-crop. It is a matter of building a stronger partnership
which involves community capacity-building, bringing traditional
healers into the research and development community and letting
their interests and values infuse the whole process. It is not
such an arm's length arrangement.
Q867 Lord Avebury:
Can I just take up where you left off, Lady Whitaker. To me this
is a very fascinating question. If you try to enter into bargains
with indigenous people to say, "You let us have your knowledge
and we will assist in your development", that would interfere
with the transition of their product into a useful pharmaceutical,
because you would have all the lawyers coming down and arguing
about how to couch an agreement that would be fair to both sides.
As Lady Whitaker has indicated, that may be a very difficult process.
Whereas if you said, "Let us consider how to develop the
indigenous communities" and as a totally separate matter
how you turn the products into useful pharmaceuticals and you
do not try and enter into some equation between the two, you might
more rapidly develop products which they have obviously got in
very rudimentary form because they do not process them. Is not
the attempt to put these processes together a mechanism for causing
serious delay and injecting a lot of financial cost into the process?
Mr Taubman: I would respectfully suggest that
that is not the case for several reasons. Perhaps the most interesting
one is that we are not talking about traditional knowledge as
a litany of interesting facts, but rather as established bodies
of knowledge and innovation systems in themselves. A lot of what
is important knowledge about traditional medicine is not that
this or that herb is potentially useful for arthritis, but rather
that there are synergistic effects that a plant, when harvested
in such a way and combined with such other herbs, in the light
of these observed symptoms, has this effect. That means that to
get the full benefit from this knowledge you need to step inside
that knowledge system and work with it. There is no alternative
to bringing the community in as part of the overall arrangement.
A second reason is an argument from the point of view of overall
equity. That has been pushed very forcefully at the political
level by indigenous groups themselves, but also by developing
countries, who argue that it is simply inequitable to view traditional
knowledge as simply just out there for anyone to use.
Q868 Lord Avebury:
Public domain?
Mr Taubman: Public domain, and just a resource
for the nimble to help themselves to, because that tends to occlude
the genuine contribution made by indigenous communities. There
is a broader equitable argument. These two rationales converge
if you look at the practicalities of bringing a new pharmaceutical
through the whole R&D pipeline. Very few companies would be
willing to invest in that risk and that difficulty not only with
that technical uncertainty, but also with this extra political
layer. In short, it is not good business to be branded a bio-pirate
while you are already going through the risky R&D process.
You do not need to buy yourself yet another area of uncertainty
and risk and political difficulty at that stage. I think it is
a much more sustainable, effective package to look at it holistically,
rather than to try to separate the knowledge providers and users,,
but obviously we are talking about very, very diverse scenarios.
As a broad proposition I would suggest it is a way that works
better. One final observation is that developing countries are
increasingly looking to indigenous medical knowledge to be integrated
with their health policy overall, as it is obviously more affordable,
more accessible than waiting for the next miracle drug to drop
off the pipeline from the developed world. There is a broader
social interest in bringing traditional medicine into the mainstream
because there are all sorts of regulatory issues and so on, but
as a discernible trend that is very clear for the most pragmatic
reasons and also for these broader questions of equity and cultural
recognition that lie behind this movement.
Q869 Lord Avebury:
It would be very interesting to me, I must say, to have an example
of where this process has led to a successful development. Although
one is aware of cases where people have capitalised on indigenous
knowledge and not given anything to the originators of it, I am
not informed of any process where there has been a reciprocal
benefit to the indigenous people. If we had a little note on that,
I think it would be very interesting. Can I ask you a second question
about what you said on genetic resources. I do worry that a lot
of genetic information, including genome sequencing, is being
taken out of the public domain and made the exclusive property
of big companies, which then take out patents and deny them for
the benefit of the wider community. Is that within your terms
of reference?
Mr Taubman: Yes, at two levels. I have brought
a draft we have been working on on the interplay between intellectual
property and bioethics. We work with an inter-agency group within
the UN on these issues. As you well know, this has been a persistent
concern: how to reconcile bioethics with intellectual property
law. We are working through it from a policy point of view, not
in terms of passing judgment to say, "You are right and you
are wrong", but rather to help frame the issues, to sift
them through. For instance, the observation has been made that
a certain proportion of the human genome has been patented and
is in private hands.
Q870 Lord Avebury:
Yes.
Mr Taubman: But what does that mean in practice?
There is a very big difference between using a shred of my DNA
to code for an artificial form of insulin, as against asserting
a claim against the DNA integral within my own cells. It gets
very technical very quickly, but I think it needs to be, just
to sort out these concerns. In this area, too, we are working
with our UN partners to sift through patent information, because
perhaps the biggest problem is making sense of mounds of patent
information, and distilling out useful observations for policymakers.
For example, we have commissioned an investigation, in the agricultural
field, of patenting on the rice genome. This helps to prepare
for more difficult work on the human genome. This research found
that around 74 per cent of the rice genome is covered by patent
applications but only 0.26 per cent is covered by granted patents.
There is a technical distinction, if you like, between what the
original applicant puts in as an ambit claim, as a broad claim,
and what is actually permitted by the Patent Office. We see this
dramatic narrowing. That might be seen as good news or bad news,
but it is certainly valuable information to get a grip on exactly
the concern about patenting the genome.
Q871 Lord Avebury:
Is it part of your remit to prevent the gradual narrowing of the
public domain through this process of people doing work on genetic
sequencing and then removing it by means of patent applications
or patent successes?
Mr Taubman: Yes, indeed. Not in terms of intervening—we
would not shoulder aside a British patent examiner and say, "You
have got it wrong here"—but by systemic improvements,
because it is simply a very demanding task to sift through this
data and make a genuine assessment of whether this claimed invention
is real contribution to human know-how; or whether they have made
an opportunistic claim after applying a very routine way to sequence
a gene. There are real systemic demands that come into play in
answering those questions. We have done work, particularly in
relation to genetic resources that are typically held by biodiverse
countries, to ensure that patent examiners are more able to assess,
if I am claiming this is a new way of creating a therapeutic protein,
that I have genuinely added something to what is already known
and what is already available in nature. To a large extent, it
is a matter of getting good useable information literally on the
screen of the patent examiner. Once again, it becomes very technical
very quickly. That is a large part of getting it right. Very few
people ultimately are quarrelling with the broad principles of
patenting, and we see convergence of understanding there, not
a formal convergence but a convergence in practice. But it is
a long step between the principle and the actual practice when
you are a patent examiner faced with a desk piled high with sequence
listings and making sense of them. It is at that systemic level
that we are trying to develop more effective mechanisms, not to
pre-empt or pre-judge what are sovereign findings of national
Patent Offices, but to build up the platform of support for their
decision making.
Q872 Lord Avebury:
And also to examine the consistency between the national Patents
Offices, is that part of your remit?
Mr Taubman: Certainly not any legal remit, that
would make us a court of appeal, if you like, against sovereign
national processes, and there is an understandable sensitivity
about that. Once again, it is more of supporting offices that
we are seeking to cooperate with and strengthen their own operations
rather than making a precise assessment on our part. I think there
would be a lot of sensitivity about that.
Q873 Lord Avebury:
If I may turn very briefly to another question. On the TRIPS Agreement
it has been suggested that the flexibilities which are built into
it are in danger of being eroded because of bilateral free trade
agreements. Have you any comment to make on that?
Mr Petit: I would say that this question might
be addressed to WTO in the first place. Bilateral free trade agreements
are in contradiction with the multilateral approach promoted by
WTO, which is their mission. To answer your question, in my own
view there is little doubt that bilateral or regional trade agreements
may be dangerous for the flexibilities and exceptions in the TRIPS
Agreement, since the strongest partner may impose its conditions
more easily than would be the case in a multilateral agreement
and in the framework of WTO. Bilateral trade agreements may contain
what is called TRIPS-plus clauses, with more stringent clauses
than the TRIPS Agreement itself. WTO is trying to say that there
should not be such bilateral or even regional trade agreements,
that the whole multilateral trade process should take place in
the framework of WTO. But, as long as the Doha Round does not
find an agreement, there is a development of these bilateral and
regional trade agreements.
Q874 Lord Avebury:
My second question concerns the technical assistance that you
provide to developing countries. I think you have already partially
responded to this in a previous question, where you said that
there had been a recent international meeting on the practicalities
of giving effect to the flexibility of TRIPS. The suggestion that
has been made by some of our witnesses is that more emphasis is
being placed on the obligations that States have under TRIPS and
less on the flexibility, and I would be grateful if you would
comment on that.
Mr Petit: Certainly. I have already mentioned
that there is a cooperation agreement between the two organisations,
WTO and WIPO, that was concluded in 1995. Article 4 stipulates
that the two organisations shall enhance cooperation in their
legal technical assistance and technical cooperation activities
relating to the TRIPS Agreement for developing countries so as
to maximise the usefulness of those activities and ensure they
are of a mutually supportive nature. In fact, WIPO gives legislative
advice to developing countries and the organisation has a duty
to inform them on the conformity of their draft legislation with
their TRIPS obligations. WIPO would say whether it is in line,
or open to interpretation, or not in line with their TRIPS obligations.
It means that we have to help them and advise them on the conformity
of their draft legislation with all the dispositions of TRIPS,
which are not only the regulations but also the flexibilities
and exceptions. We advise them on conformity with the TRIPS Agreement,
not with TRIPS-plus. Maybe more important, our organisation advises
the developing countries' governments and countries in transition
as well, on national intellectual property strategies so that
they define their own national strategies in the field of intellectual
property. We advise them to define strategies which are adapted
to the special conditions of each country, taking into account
its level of development, its own culture and national characteristics.
All of this is enhanced by the Development Agenda. We could summarise
this by saying it is not one-size-fits-all, which is the expression
that has been used in discussions on the Development Agenda. We
have to advise on all dispositions of the TRIPS, including flexibilities
and exceptions, but also we try to take into account the national
characteristics of each country. Maybe Tony would like to add
something.
Mr Taubman: Thank you, yes. Perhaps, again,
this is an area where there has been a historic shift. The TRIPS
Agreement came into effect for developing countries in 2000 for
the large part, and I can tell you that in other guises—unrelated
to my current position—I was personally involved in this
process from 1995-2000, when there was something of a scramble
in many developing countries as they took on a really formidable,
imposing legislative task. That was one reason why there was an
emphasis on implementation as such. As practical legislators yourselves,
you could imagine us advising a national Government having to
introduce eight parallel major intellectual property bills to
comply with TRIPS. That in itself is an enormous task. That legislative
effort was something of a concentration in that period from 1995-2000.
However, since that time, and noticeably with the Doha Declaration
of 2001, we have seen a major shift in emphasis. It is not my
area in WIPO, but I know the people working in that area are increasingly
being asked by Member States, (and it is exclusively demand-driven)
to advise on areas of flexibility. In the area of medicines this
includes strategies for parallel importation, alternatives for
protection of clinical trial data, implementation of the compulsory
licensing mechanism established following Doha, and so on. It
is a matter of putting before the Member States, "This is
your range of options, these are your flexibilities" and
ultimately the question is how do you want to flex them. That
is a matter of national sovereignty—"Here is your space
to work in". We help to identify and define the options.
Then it is a matter for national policymakers to go through the
sovereign legislative process—"This is the formula
we have worked out, this is applicable to us". It is not
our role to second-guess the national process but to lay out the
range of options. I think my colleagues would say with confidence
and pride that they do indeed lay out the full range of options
right up to the very edges of that flexibility.
Lord Avebury: Can you get as far
as laying out the range of options in a series of models without
contradicting the one-size-does-not-fit-all? Is it possible to
think in terms of the preliminaries to legislation, such as the
instructions to counsel on what we would call a preliminary document
that goes to the lawyers who draft the legislation in terms of
the series of options that you mentioned? Similarly, in the national
strategies on IP, can you lay out the series of options in a standard
document which, while offering choices to sovereign states, allows
them to pick from a menu, as it were?
Q875 Chairman:
If you could answer that fairly briefly, it is a complex and important
question but we are getting quite tight on time. I do not know
if you can give a brief answer, or maybe write in if you cannot.
Mr Taubman: I can give a very precise example
in the area of parallel importation, for example. There is a range
of options from strict national exhaustion, as it is called, to
entirely open international exhaustion, and the options set out
are a spectrum between those. That is what would be given to reflect
upon.
Q876 Lord Desai:
A brief question about this episode in 2005 when there was this
flu pandemic and at the time it was critical. Did you have any
power to compel the pharmaceutical company to allow more production?
Or, in general, do you think there are problems of IP preventing
this sort of generic development?
Mr Taubman: Once again, we do not have express
power to do that, it would be a matter of intruding in domestic
processes, because the patents concerned are held within national
legal systems. However, it is an area where information has been
desperately needed. I was in one country that year where there
was a huge debate about this question. The question arose whether
it would be appropriate to issue a compulsory licence for a flu
drug but it turned out there was no patent on the drug in that
country. We are talking therefore about a fundamental need for
factual information which perhaps we take for granted in the developed
world but is desperately needed elsewhere. Such information has
important practical implications. For example, in this case the
pharmaceutical firm Roche was not the patent holder (though it
was often assumed to be), but rather was the licensee. The patent
was held by a firm called Gilead, which was in the middle of re-negotiating
its licence with Roche. This changed the whole complexion of how
you practically deal with this situation. Once again, we would
seek to provide information about what your options are, but to
intrude in a domestic policy-making process or a choice over what—
Q877 Lord Desai:
Is that sort of knowledge not in the public domain? You cannot
just go to WIPO and find out?
Mr Taubman: In principle, it is in the public
domain; in practice, in many countries it is very difficult to
obtain. Once again, it is part of the background support we are
doing, going from country-to-country and bringing this material
into accessible digital form.
Q878 Chairman:
Is it difficult to get in the public domain because it is not
in one place? Or because you would need a legal interpretation?
Or what?
Mr Taubman: There are two aspects. There is
actual access to the patent document concerned, and in countries
with limited resources and overworked bureaucracies the files
are not in very good shape. It resembles my office, to some extent,
with random piles of paper. It is difficult to get the information
in a systematic way.
Q879 Lord Avebury:
You could put it on the web?
Mr Taubman: To turn that pile of paper into
something you can access, that is the very objective and we have
a programme of progressively doing that right now. In time the
problem will be solved. It is not a matter of unwillingness, it
is quite a technical task to go back 20 years and digitise these
paper files. The second aspect is the legal question, interpreting
this patent under national law, and that is difficult. In the
UK there are hundreds of years of patent law, there is some predictability
about what is the exact scope of the exclusive right; but for
a country that has recently introduced patent law there is no
background of jurisprudence, so, unfortunately, it is inherently
uncertain and that is something that will have to work its way
through the system over time. It is difficult to assess in the
short term.
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