- Prof. Carlos Mara
Romeo-Casabona, LLD, MD
Director, Inter-University Chair
BBVA Foundation – Provincial Government of Biscay in Law and the Human
Genome, University of Deusto and University of The Basque Country, PO Box 1/E
48080 Bilbao,
Spain.
Email: cromeo@genomelaw.deusto.es
Eubios Journal of Asian and International Bioethics 14 (2004), 203-208.
1. The original
purpose of the European rules concerning biopatents was twofold: on one hand,
to harmonize the European legislation on biotechnological patents, and on the
other, to contribute to the development of biotechnological research in Europe
so that it is not relegated behind the North American and Japanese
biotechnological market, mainly (Lema 1999). But through the nineties Europe
was involved in a intensive debate, according to it patenting life should be in
compliance with recognized standard ethical principles.
The necessity for a Directive was urgent, because the
practice of biotechnological inventions had shown the
differences
between national laws regarding patents in the different member states.
Furthermore, this kind of difference could be increased not only by
administrative performances but also by juridical interpretations, what could
lead to hinder the operation of the inner market and even to go down the
industrial development of inventions in this field.
From the original text of the first Directive proposal on
legal protection of biotechnological inventions of 1988 until the text finally
approved in 1998 there have been several very important changes in it. The
first draft of 1988, had a total lack of ethical (Hermitte 1998)
considerations, it was mainly a Directive devoted to solve patentability
problems; in this sense it was considered that it was a juridical text with
purely technical character (Lobato 1998). However, the current Directive is
full of ethical considerations, in the sense that it acquires a position
devoted to solve the ethical questions related with the patentability of living
matter and of parts of human body, including in that human genes (Bergel 2000).
2. In the other side, the Governments of some countries of
Asia (India), Africa (South Africa) and Latin America (Brazil), among others,
were confronted with the problem of providing some of vital drugs (such as
medications against AIDS) for their respective populations. It was also both an
economic concern, as these countries are not complex drugs inventors, and an
ethical dilemma as those governments could not sit down with their arms crossed
and to accept the death of thousands of infected persons. There is also a great
perplexity considering that these countries provide human subjects for some
clinical trials (i. e., for AIDS drugs) funded by very important northern
companies, and there is a claim to ensure that these patients benefit from the
new drugs after the trial is accomplished (European Group 2003), in terms to
prevent to exploit the vulnerable (Nuffield Council 2002).
The important European Directive on the legal protection
of the biotechnological inventions
(Directive 98/44/EC of the European Parliament and of the Council of 6 July
1998 (OJ EC of 30 July 1998) will have to be considered by the Member States
bringing into force laws, regulations and administrative provisions necessary
to comply with this Directive, what has already happened in many States. On the
other hand, the European Convention on the Patent of 1973 has also been revised
in 1999 to adapt it to the new legal framework settled down by the Directive.
The new European regulation has given a general answer to
the numerous conjectures that this matter rises: that the biotechnologies will
be legally protected, in a main or exclusive way, through the patent. Any other
artificial solution different than the patent has been rejected, settling down
the relevant aspects that differentiate a discovery from an invention. As it
has been checked, this was one of the most controversial points on the
favourable or contrary arguments to the patent.
On the other hand, in the Preamble it is proclaimed that it
is not sought to substitute the existent national general framework on patents,
but rather "the rules of national patent law remain the essential basis for the
legal protection of biotechnological inventions". (Recital Nr 8). However,
there has been a lot of interest in emphasizing that it should be demonstrated
anytime that the presumed novelty or biotechnological innovation fulfils each
and every one of the traditional requirements of the patent. Concretely, the
Preamble and the articles of the Directive stress that the applicant must
demonstrate convincingly the industrial application of the biotechnological
product. That is to say, its utility should be fully defined and clearly
exposed as well, although it is certain that the Directive makes more flexible
the understanding of the other two requirements of the patent (to be new and
not obvious inventions) when it deals with Biotechnology.
Another concern of the authors of the Directive (the Parliament
and the Council) is to make as clear as possible what can be patentable or not
on biotechnological matter, mainly in connection with human biological elements
or when the human body is somehow involved, but also when animals or vegetables
are.
This reiterated concern in the conceptual clarity explains
that, the Preamble has 56 Recitals, while the articles are only 18. That is to
say, it has worried more to clarify what it is sought to regulate and with what
sense than the regulation itself.
In summary, which is the new European normative framework
that the Directive on the protection of biotechnological inventions
establishes? Explicitly it appeals to the national law on patents,
notwithstanding the necessary adaptations to take account of the provisions of
this Directive (art. 1). Consequently, according to this prescription, the
adequate legal framework for the protection of the biotechnological inventions
is the law of patents.
The Directive states, as a general principle, that a
product consisting of or containing biological material is patentable. Also,
the process by means of which biological materials are produced, processed or
used; as long as they comply with the traditional requirements of the patent:
new inventions which involve an inventive step and which are susceptible of
industrial application. (article 3.1)
Consequently, biological material which is isolated from
its natural environment is patentable, or also if it is produced by means of a
technical procedure, even if it previously occurs in nature (art.3. 2).
The nuclear approach of this Directive, regarding the
patentability of human genes or parts of them, is based on this precept, just
mentioned; because such a possibility is admitted under the above- mentioned
conditions. This does not prevent the Directive from clarify it even more
specifically, as we will confirm below.
Regarding the human biological material, it points out
expressly that they will be able to be considered as a patentable invention:
"An element isolated from the human body or otherwise produced by means of a
technical process, including the sequence or partial sequence of a gene, may
constitute a patentable invention, even if the structure of that element is identical
to that of a natural element." (art. 5.2). In any case, it emphasizes that "the
industrial application of a sequence or a partial sequence of a gene must be
disclosed in the patent application."(art. 5.3).
On the contrary, "the human body, at its various stages of
formation and development, and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot constitute
patentable inventions"(art. 5.1).
As for the exposed patentability conditions, there is still
a debate on whether the sequence of a gene or part of it, isolated in a
laboratory or obtained by other technical process, really constitutes an
inventive activity. Indeed, it is pointed out that a gene or a functional
fraction of DNA can be identified with a chemical molecule. But an essential
difference remains: what really is relevant of that molecule is the genetic
information of which it is carrier, and not its basis itself. If the structure
of this information "is identical to the one of a natural element, we have a
discovery, not an invention" (Bergel 2000). Consequently, against the approach
of the Directive, according to the contrary opinion, the reproduction by means
of a technique procedure or the isolation of that information or knowledge would
not constitute an inventive activity, what is an essential requirement for
recognising the patent. This is so regardless that the technique procedure for
the reproduction or isolation of an element of the human body may constitute an
inventive step.
The object of the Directive is not limited to the
biological components of human origin. So, inventions concerning plants or
animals shall be patentable if the technical feasibility of the invention is
not confined to a particular plant or animal variety (article 4.2), according
to the juridical tradition in this matter.
In accordance with the Directive, microbiological or other
technical processes, or a product obtained by means of such a process, are also
patentable. (article 4.3) This rule is not a novelty either because it was
allowed before at the European Patent Convention. Nevertheless, this
recognition is just an exception to the exclusion of the patent of the
essentially biological procedures for obtaining plants or animals. (article
4.1b) The explanation of this normative lies in that, once the micro-organism
has been produced, it is able of natural, fast and abundant self-reproduction
or self-multiplication.
Another issue gave place to concern, in this case of the
breeders. It was the risk of becoming dependent of the big companies of seeds
and livestock improved by genetic procedures. So that, for each new sowing or
reproductive period they would have to acquire the corresponding products
onerously (e.g., seeds or breeding animals) or to pay a canon or any other kind
of payment to these companies, with the corresponding price increase of their
agricultural exploitations. This fear has been wanted to solve with the so-
called "breeder's privilege". According to this privilege, the farmer will be
able to use the product of his harvest for propagation or multiplication by him
or her on his or her own farm, and as well the use of the livestock or
reproductive material for the purposes of pursuing his or her agricultural
activity. (art. 11).
Regardless of the concurrence or not of the requirements of
the patent, the new system excludes the normative framework of the inventions
whose commercial exploitation is contrary to the public order or morality (the
"good customs") (art. 6.1). It is an excluding clause that already appeared in
the European Convention (the Convention of the European Patent of 1973).
Although, in fact it has never been applied, neither by the Office of European
Patents or by any other national Court. Such an application lacks a response to
pragmatic reasons and is difficult to apply itself. On the one hand, there was
an evolution regarding a more flexible concession of the patents. On the other
hand, it is always difficult to apply indeterminate juridical concepts as
public order and morality are.
Anyway, as a projection or concretion of this general
clause of exclusion, the Directive rejects expressly, in connection with human
biological material, (i) processes for cloning human beings, (ii) processes of
modification of the germ line genetic identity of human beings, (iii) as well
as uses of human embryos for industrial or commercial purposes (art. 6.2).
As I have already pointed out on several occasions
(Romeo-Casabona 2002), the admission of the patent should not be mistaken for
its admission or prohibition in another sector of the normative system. That is
to say, appealing to an example, that the processes of cloning human beings is
not patentable, but there could be, however, a law that allowed it -or, on the
contrary that prohibited it-. So that one thing is to allow the activity as
such, and another very different thing is to recognise or not the patent of a
product or a process where the activity lies.
With regard to this, it should not be forgotten that the
concession of the patent brings out the ability to prevent a third party from
exploiting the invention with commercial purposes without the authorisation or
consent of the patent holder.
Probably in connection with these matters and with the
public order clause, the Directive contents a provision: "The Commission shall
send to the European Parliament and the Council every five years a report on
any problems encountered with regard to the relationship between this Directive
and international agreements on the protection of human rights to which the
Member States have acceded" (art. 16 a).
Lastly, and for the same public order reasons, the patent
will not be granted to processes for modifying the genetic identity of animals
which are likely to cause them suffering without any substantial medical
benefit to humans or animals and also animals resulting from such processes
(art. 6.2, d). This is an appropriate –but still not enough- way to
prevent transgenic animal researches that should have scientifically nonsense
but could cause them suffering.
Initially there was not a special diligence on the part of
the Member States of the EU to adapt the respective internal laws to the
Directive.
Nevertheless, it can be affirmed that nowadays the States
that have already adapted their systems to the Directive constitute a majority.
However it seems that there has not been unanimity among the Member States as
for their attitude in this respect. This attitude, we could classify in three
main positions.
1) The first of them would be integrated by the States that
have already begun or concluded the adaptation of internal laws process.
2) The second attitude would be represented by France,
whose National Consultative Committee of Ethics on Sciences of the Life and
Health has intervened on this matter. In its conclusion on this question the
Committee was openly contrary to the incorporation of the Directive to the
French legislation (Law of 29 July 1994), since at this moment it would be
ambiguous and it would not clarify the position of the investigators. The
Committee considers a debate necessary, before removing the principles that
inspire the French legislation: the knowledge of the sequence of a gene cannot
be assimilated in any case to an invented product, and therefore it is not
patentable. Its use, as of all knowledge, for the common good of the humanity,
cannot be limited by the existence of patents that would seek, on behalf of the
industrial right of industrial property, to protect the exclusivity of such
knowledge. That is to say, the French Committee proposes the free access to the
knowledge of the genes or parts of them. However, this ethical (properly
speaking: legal) solution would not be peaceful either, since some private
company of the consortium that made public the conclusion of the map of the
human genome, renounced the patent of the sequenced parts of the genetic map
obtained by it, but it didn't renounce to sell them as commercial information
to those who could get an economic benefit from the investigations that they
have carried out with them.
It is certain that the Opinions of the referred Committee
are not binding for French authorities, and that apparently the French
Government had already begun the adaptation process, but it is not less certain
than their Opinions reflect a very influential and in general very respected
criteria. In my view this Opinion should be very relevant for the debate previously
to the approval of the Directive, but in fact it came too late,
3) The following approach was a result of the appeal
presented by two Member States of the EU to the European Court. It was an
annulment appeal presented by the
Netherlands in 1988 against the Directive 44/98/EC. A little bit later, in
December 1998, the Italian government presented a similar annulment appeal. The
Norwegian Government also presented it, but it committed some procedural
mistakes. The line of argument is based on several aspects, but we could
highlight the argument that the Directive affects the fundamental rights, human
dignity, since it allows patents on human material. Moreover, it did not settle
down any provision with regard to the recipient of material biotechnologically
treated, what attempts against the principle of self determination of the
patients.
The European Court of Justice has answered this appeal,
having rejected it in each and every one of its terms (ruling of 9 October
2001). The most relevant arguments were the following ones: i) it is not a
matter of the creation of a new law, since it deals with national patents for
which the procedure and the national law are applicable. ii) The Directive was
the only way to guarantee the correct operation of the interior market, given
the legislative divergences of the Member States on this matter, therefore, the
subsidiarity principle is not harmed. iii) The Directive does not bring out a
violation of the human dignity, because it limits the patent in a sufficient
way so that the human body remains indeed not disposable and inalienable. For
example, when excluding the patent of the human body and its parts at the
various stages of its formation and development, and when considering some
procedures specifically contrary to the order public and morality, and for that
are not patentable.
6.
Some critics opposed to the Directive
Seemingly, the process of uniform regulation on the
protection of the biotechnological inventions in the Europe Union was already
closed since the Directive was approved by the corresponding Community bodies.
Nevertheless, as we have been able to check above, it is
not like this the situation, and some important critics to the normative of
patents that has been established, have raised. Here there are some of them:
1. We
have already seen before the form or content arguments presented against it,
the reticences that it still brings out in relevant advisory institutions.
2. It
has also been criticised that the Directive has excluded of its articulated
part the demand of the consent of the people from whom the biological samples
come when a patentable invention
has been obtained. Without wanting to judge whether it is or not an appropriate
requirement -although at least I want to point out that it is a question that
should be kept in mind-, the truth is that it does not seem a characteristic
matter of the patent and that, in consequence, it should be solved by the
industrial property law.
3. Let's
remind that it has been argued that the genes and their parts (the sequences of
DNA), even though having been isolated in the laboratory, they contain
information –they are knowledge-, and this is what really interests as an
object for a possible economic exploitation. This information already exists in
the nature, for what, from this point of view, it would be a discovery and not
an invention.
4. There
would not have been a sufficient reflection to order what can or cannot be
patentable.
5. Some
patented inventions regarding health are already a reflection of the access inequalities
to them, because they are giving place to exorbitant economic rights (e.g., the
case of the diagnostic products of predisposition to the breast cancer in the
United Kingdom).
Talking about patents, many things have radically changed
since the entry into force in 1995 of the Trade related intellectual property
subjects (TRIPS) in the World Trade Organisation. The WTO is the only worldwide
economic organization with an effective sanctioning capacity, through its
Conflict Solution Organ, to the countries for the unfulfillment of its rules.
It includes crossed reprisals: for example, a commercial sanction for violating
the TRIPS. This explains the strange and gnarly presence of the protection of
intellectual property in the WTO that reinforces and widens previous
agreements. Also it means the generalization from the system of patents to all
the technological fields and with a minimum duration of the monopoly of 20
years.
This benefits the big multinational companies of Northern
countries that own the property of the immense majority of the patents. In
fact, TRIPS was developed from the necessities of these companies. Indeed,
firstly a dozen of big American companies from different sectors, half of them
being pharmaceutical or biotechnological companies, constituted an Intellectual
Property Committee (IPC) with the explicit objective of including that issues
in the calendar of the GATT during the Uruguay Rounds (1986-1994). Soon, the
IPC got the support of the European employer's association UNICE and the
Japanese Keidanren to put the pressure on the governments. And in 1988 this
Triad coalition, without precedents, went to the GATT director and gave him the
draft of what, with the support of its governments, became the TRIPS.
For most of Southern countries, the TRIPS is a way for a
harmonization of their protective legislation of intellectual property,
reaching the level of the most advanced economies. They have a transitory
period that ends in the year 2000 or 2005, according to each case. For
pharmaceutical products the date for most of Southern countries is the second
one, except for those "less developed" (the Southern 49 most poor
countries) that initially had one more year and, after the IV Ministerial
Conference of the WTO, in Doha on November 2001, they have time until 2016 for
the full application of patents in the pharmaceutical sector.
It is all about facing interests. On one hand, Northern
pharmaceutical companies and on the other hand Southern governments that try to
generalize the existing treatments against AIDS. And in fact they have already
fought in several occasions, some of them are very well-known. The case of the
big pharmaceutical multinationals against the Government of South Africa
(presented in 1998 with the support of the US Government and retired in 2000,
and continued in the US courts until April of 2001) had a lot of echo in
Northern countries. Although less, the claim of United States in the OSD of the
WTO against the Brazilian program against AIDS, (presented in 2001 and retired
months later) is also known.
However, the Doha agreement did not clarify how Southern
countries could benefit of that declaration if they do not have a local
pharmaceutical industry able to produce medications under an obligatory
license, because its import could be in conflict with other TRIPS dispositions.
This explanation should have been done by the WTO before the end of 2002, but
there was no agreement. Indeed, despite the important (excessive) surrenders of
Southern countries, the stinginess of the United States, the European Union,
Japan and Switzerland that defended the interests of their pharmaceutical
industry, impeded a consensus solution. In those negotiations, the United
States had a particularly strict position. They tried to limit even more the
agreement, restricting it to fewer diseases, but it is to be underlined that
the Doha Declaration refers to the protection of the "public health"
in a general way. And what just before the beginning of the Fifth Minister Conference of the WTO in
Cancun in September 2003 appeared as an agreement to facilitate the implementation
of the Doha Declaration, it means a group of new obstacles that make it even
more difficult of applying, as we will see below.
Anyway, the hopeful forward step given in Doha would not
have been possible without the campaign of access to essential medications
promoted since 1999 by diverse NGOs. That campaign has had a remarkable
repercussion in Northern citizenship, and in some international organisms.
Among them, World Health Organisation (WHO), that includes in its priorities
the access to generic medications and TRIP's repercussions, even though there are
some people that consider that it is placed in favour of companies. It has also
given place to interesting resolutions such as number 2000/7 of the
Subcommittee of Human rights of United Nations which denounces the negative
implications of TRIPS on the rights to feeding and health, and affirms their
primacy over economic policies and intellectual property, sustaining that
patents on pharmaceutical products should serve of social welfare. Or
resolution 2001/21 of the Commission of United Nations on Human Rights that
recognizes that the access to medications is a fundamental element for the
progressive full realization of the right of everybody to enjoy the highest
reachable levels of physical and mental health and it requires the states to
assure that the application of international agreements is compatible with the
public health.
Because of this, and as the North concentrates the demand
of medications and originates most of the benefits of the pharmaceutical
industry, the companies retired the demand against South Africa, in order to
keep a good image. For that reason they also accepted the less harmful,
Declaration of Doha. Nevertheless, we should underline that it is a simple
interpretation of the Agreement, which has not been changed at all, exactly what
multinationals and Northern countries wanted. So as to keep Pandora's box
closed, due to the questions made on TRIPS from many Southern governments and
NGOs. Therefore, in the field of access to medications there is still a lot to
do. Even more when the incorporation of more restrictive versions of the
protection of intellectual property, often denominated TRIPSplus, is present in
the negotiations of regional integration agreements as the case of America's
Free Trade Area.
At the end of August 2003 the World Trade Organization
announced a new agreement with developing countries on pharmaceutical products
patents. This historical Agreement raised hopes among the numerous African
countries and doubts among the NGOs regarding its capacity to help the millions
of people with AIDS, malaria or other infectious disease because they
considered it too complicated and with a difficult application. Definitively,
through this agreement poor countries can import generic medications to fight
more than twenty diseases.
The text was blocked since December 2002 by some countries
–as the United States- because they were trying to protect their
pharmaceutical industry. After these eight months of blockage, the 146
countries of the WTO, allowed the poor countries to import generic medications
–which are the same components than patented medications but are much
cheaper- to help fighting serious problems of public health. The WTO solved in
this way, a controversial question, ten days before the Fifth Ministerial
Conference of the WTO that took place in Cancun (10-14 September).
Although the agreement received the praise of several
instances (WTO, the European commissary of trade, the international federation
of pharmaceutical companies and even the ambassador from Kenya), it received
the critics of several ONGs for its doubtful practical use due to its
complicated mechanism, and the fact that it is not very clear legally. Among the
adopted measures it is foreseen that Governments that want to import generic
medications should demonstrate that they really need the medications, that they
have a lack of money to buy patented medications and that they cannot produce
them at a local level. Several clauses have been established to avoid the
commercialisation of generic medications dedicated to poor countries in rich
countries, and to avoid the inclusion as generic medicines some of them which
are important sources of money for the pharmaceutical industry, such as the
products against obesity and impotence.
The decision will allow countries like India, Brazil and
Sputh Africa, which have the needed infrastructure for production, to elaborate
patented medications by pharmaceutical companies from all over the world if
they only dedicate them to export to needy nations.
One of the biggest disagreements was referred to the
diseases that should be included in the agreement's list that allows the
treatment with generic medications. While the USA defended that this
possibility would be limited to the treatment of AIDS, malaria and
tuberculosis, other parts such as the European Commission, thought that the WHO
should decide, if there were any doubts, about the diseases covered by this
multilateral mechanism with the possibility of incorporating any disease in the
case of a sanitary emergency defined by the affected country.
Big pharmaceutical companies had argued that such an
agreement could relax the normative on the protection of medication's patents
in whose development they had invested billions of dollars. They feared that
low cost producers like India could find a pace to introduce their products in
the markets of developed countries and use their technologies to impel their
own benefits instead of making it with humanitarian goals. Answering this
situation, the WTO has included a declaration in the agreement where it says
that the countries will only be able to overcome the patents "with good
faith and to protect public health... and not as an instrument to achieve
industrial or commercial objectives".
This Agreement includes certain conditions to guarantee
that its final goals are fulfilled. To begin, medications manufactured as
generic and destined to fight epidemics in developing countries, will have a
different package and pills colour to those used in other countries to avoid
their importing to developed countries. The system includes about 20 diseases,
but it has an annual revision to adapt it to specific necessities.
It seems that demanding the patents in courts when they
limit the access to medications is getting usual, as it recently happened
(February 2004) in Thailand, where a court decided to agree with two
HIV-infected patients that had denounced the Bristol-Myers Squibb laboratory
for blocking their treatment due to the rights of industrial property of one of
their antiretroviral, opening in this way the road to the production of the
generic medications. The court judged that patents damage the patients whose health
and life depends on if they can or cannot pay the price of the medications
needed to stop the advance of HIV in their body.
Currently, the Thai Government produces a series of
generics that are 25 times cheaper than the original versions. The treatment
against AIDS is different, since these medications are still protected by
patents and are too expensive.
It seems that the performances of the NGOs will follow the
pace of demands, because recently (at the beginning of March 2004) Mdecins
Sans Frontires (MSF) has accused the pharmaceutical company Merck of breaking
the promise made 16 months ago of reducing, in poor countries, to less than a
dollar the prices of antiviral efiravez (EFV) against AIDS. According to MSF,
Merck accepted that discount in a key medication for the combined therapy,
mainly for patients with HIV and tuberculosis. However, until now Merck has not
registered it in countries like South Africa, Malawi and Nigeria. The failure
of Merck means that patients of poor countries have to continue taking three
pills to a price 44% higher than the promised one.
It is a common statement that we are at the globalisation
era. Whatever it could mean I think that globalisation should not – or
not only- be a way to open the markets for producers around the world; and not
only to promote partially some ethical views, regardless they could contain
universal values.
Globalisation should be rather a way to improve
responsibility, solidarity, tolerance and understanding among the nations and
the people. Today's problem posed by the access to basic and/or vital drugs at
developing countries needs:
i)
For equity at benefits by producers, taking into account that
intellectual property rights (patents) can still deserve an useful way for
protection of inventions, but at the same time preventing that they could
perpetuate poverty of developing countries.
ii)
it is not contradictory to this to explore some flexible ways of
different nature and intensivity to extend ethical concerns when collective
dimensions are involved, as could be voluntary licences, anyway preventing
their misuse, or giving medicines free or at reasonable prices for developing
countries when vital o endemic diseases are involved.
iii)
Notwithstanding, taking durable measures is the most desirable way to
shorten distances among North and South. To implement North-South interactions
those measures could consist of promoting joint venture projects, improving and
funding some local industries according to the potentiality of the conmcerned
country (startup), and transferring technology as well as establishing cooperative research programms.
iv)
Responsibility for a good management of resources by authorities of
developing countries, even when these are scarce.
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The author wants to stress warmly his thanks to Dr. Amelia Martin-Uranga for her helpful collaboration to prepare this contribution.