Civil Society - World Superpower

The CIVICUS World Alliance for Citizen Participation held its 6th World Assembly last week in Glasgow, Scotland, with meeting documents published by Terraviva, an independent publication of the IPS-Inter Press Service news agency.

CIVICUS is an international alliance of around 1000 members across about 100 countries, advocating citizen action and civil society participation throughout the world. Emphasising participation and active citizenry as the foundation for development, CIVICUS aims to provide information and resources for civil society. Its global headquarters are in Johannesburg, South Africa, although CIVICUS was originally based in Washington DC.

The Assembly came at a time of increasing attention on civil society activity, not only in terms of international debate, but also in the form of growing economic influence, in the form of consumer boycotts, ethical consumerism, and so on.

Nevertheless, some remain less optimistic about the capacity of civil society in the context of international norm setting and public policy making. In an article in OneWorld South Asia, Tiberius Baraza, a researcher in the Governance and Development Department at the Institute of Policy Analysis, Nairobi, Kenya, describes civil society participation as "elementary." Similarly, Faith Kasiva, executive director of the Coalition on Violence Against Women, describes the "consultation" process as mere "rubberstamping."

Nevertheless, civil society is undoubtedly growing as a critical aspect of international policy and legal developments. Professor Graeme Dinwoodie, speaking at the Birkbeck AHRC Copyright Network Conference earlier this week, suggests that the nature of international legal development is much more complex than intergovernmental debates and agreements, noting a greater role for non-governmental organisations and civil society.

This capacity of civil society and its importance in development is emphasised in a recent article considering socio-economic and political circumstances in Morocco. An effective civil society is identified as critical to the facilitation of development. However, development planners have suggested that the lack of such organisation in Morocco has slowed efforts to improve citizens' circumstances. In particular, the 5 year National Initiative for Human Development (NIHD), launched by King Mohamed IV last year, has been somewhat weakened by the absence of a "robust" civil society. This has been the case despite the explicit identification of civil society's involvement as critical to the plan at the time of its launch.

Importantly, what is emerging is the significance of civil society in the economics of development. Professor Robert Innes recently published a paper in the Economic Journal of the Royal Economic Society, describing the increasing sophistication of civil society strategies and consumer boycotts, particularly in the context of ethical consumerism.

In collaborating internationally on the development dimension of intellectual property laws, diverse civil society organisations are working together to increase their policy influence and interact critically with political entities. This week, civil society and governments met in Geneva for the Second Session of the Provisional Committee on Proposals Related to a WIPO Development Agenda. However, as reported by IP-Watch, claims of a persistent bias in favour of countries against the development agenda suggest that the future of these discussions may be threatened.

Nevertheless, arguably the presence of a "robust" international civil society is somewhat of an assurance that the development agenda will continue to "irritate" those most against.

European Patent Office - Annual Report Now Available

The European Patent Office (EPO) today published its Annual Report for 2005.

In his Foreword to the Report, Professor Alain Pompidou, President of the EPO, emphasises the quality of patents as a critical issue: "Quality is a key to the future of the European patent system."

As well as the quality debate, Professor Pompidou highlights the political, cultural, and ethical context in which technologies are patented. In this area, the Scenarios project is an important initiative of the EPO. In this project, the EPO has undertaken extensive interviews internationally with users, experts, and critics. I was interviewed as part of this project earlier this year.

The material arising from these interviews will be compiled and published in 2007, as the basis for future policy development in Europe for 2020. As Pompidou states, "By systematically examining and analysing the material it has gathered, the Office hopes to establish meaningful scenarios for the future development of the patent system."

The Annual Report is available on the website as well as in hard copy by emailing infowien@epo.org.

GM Food in Europe and Beyond - Consumer Trends

In Brussels today, Friends of the Earth Europe (FoEEurope) urged EU Environment Ministers to introduce tougher safety rules on GM foods.

In today's press release, Adrian Bebb, GM Campaigner for FoEEurope, suggests that the European Food Safety Authority (EFSA) appears biased towards the biotech industry rather than the public, in defiance of public concerns about GM crops. The FoEEurope press release reports that the European Commission has also been critical of the EFSA. In April, the Commission criticised the EFSA, calling for greater transparency and scientific consistency on approvals on genetically modified organisms (GMO). Indeed, the Austrian Presidency suggested that the EFSA exercised GMO bias, approving GM products without proper research. The Austrian Presidency announced the re-opening of the debate over safety assessment in March this year. Austria remains one of the supporters of the de facto moratorium on GM crops in Europe. However, FoEEurope reports that the incoming Finnish Presidency has closed the doors of these discussions to environmental groups.

Previous posts, including the recent post on the Eurobarometer on biotechnology, have reported that European citizens remain concerned about the introduction of GM crops in Europe, despite an overall confidence in biotechnology as a whole. Tomorrow, in Luxembourg, environment ministers are to discuss new proposals to address the approval of GM products.

Co-existence of GM crops with traditional and organic systems of agriculture remains a critical issue in Europe, as reported here previously in Co-Existence and Co-existing: Disharmony? One of the important aspects of this debate in Europe is not only the cultural context for European agriculture, but also the commercial viability of organic markets.

However, increasingly, the commercial value of organic is being reported in other jurisdictions. US consumers are also becoming "greener," according to a report, by Brad Dorfman, from the Reuters Industry Summit in Consumer and Retail held last week. While GM continues to be associated with risks to the environment, such "greening" will arguably include similar choices with respect to GM food, as currently seen in Europe. Indeed, this comes at the same time as the recent decision in Santa Cruz County, California, to ban GM crops, as discussed in a previous post. It was suggested in a report in the San Francisco Chronicle online that the Santa Cruz County Supervisors were responding to Monsanto's purchase of Seminis, the world's largest vegetable and fruit seed company, prompting concern that the company would be extending GM technologies into crops traditionally grown in the Californian county.

And non-GM is said to be "booming" in the developing world as well, as reported by Reuters India. Indian soybean meal exports are expected to double, attributable to demand and competitive prices and because "Everywhere Indian meal was better accepted this year because it is non-genetically modified and of good quality," according to the Chairman of the Soybean Processor' Association of India (SOPA), Rajesh Agrawal.

In the United States again, the Foundation on Economic Trends (FOET), founded by economist, Jeremy Rifkin, released a white paper earlier this month, describing the "obsolescence" of GM and the growth of technologies compatible with agroecological approaches, blurring the common claims of "technophobe" levelled against those resisting GM crops. The white paper outlines the importance of marker-assisted selection (MAS) as the "new" agricultural technology, "within the context of a broader, more holistic, agroecological approach to farming."

This technology is being applied in research in Australia, in the case of wheat. In my homeland, research into non-GM wheat breeding technology is, according to an article by the Network of Concerned Farmers, leading the way. Research Director of the Cooperative Research Centre for Value Added Wheat, Dr Bill Rathmell, describes the importance of marker assisted selection in realising non-GM approaches to breeding technologies. The story also notes the "strong economic promise" of this research, as it was described in a recent study by the Australian Allen Consulting Group.

It seems that non-GM research is proving popular not only with consumers, but also with funders and research institutions, responding to what appear to be growing commercial advantages.

GRAIN Report: Sustainable Monoculture? No Thanks!

A new report from GRAIN criticises corporate initiatives to promote sustainable monocultures.

Sustainable Monoculture? No, thanks! is strongly critical of not only the transparency of such initiatives but also the scientific validity of such claims. As the accompanying press release states, "It is flawed to think that a monoculture of one crop can be sustainable."

GRAIN is an international non-governmental organisation (NGO), established 16 years ago during arguably the early period of increased awareness of the loss of biological diversity and threats to food security. GRAIN is committed to the promotion of the sustainable use and management of agricultural biodiversity. Building upon local and community control over genetic resources and local and traditional knowledge, GRAIN maintains that genetic resources represent not only genetic diversity but also options for development for many communities and regions.

Pre-emptive Strikes - States and Counties Battle over GM Regulation

In the United States, a recent factsheet suggests a rise in state bills supportive of agricultural biotechnology, to head off attempts by local and county authorities to regulate genetically modified (GM) crops.

The US-based Pew Initiative on Food and Biotechnology (Pew) was established in 2001. Its mission is "to be an independent and objective source of credible information on agricultural biotechnology for the public, media and policymakers." Importantly, the Initiative recognises the significance of consumer perspectives and attitudes not only to the technology, but also to the regulatory system itself. Indeed, as discussed here in a recent post on consumer attitudes to biotechnology in Europe, the latest Eurobarometer report suggests that resistance to GM food in Europe is not resistance to the technology as such, but rather, lack of confidence in the ability of regulatory mechanisms to mitigate perceived risks to the environment and to organic and traditional agricultural markets.

Pew's recent factsheet (accompanied by a legislation tracker) concludes that state legislatures are acting to stifle local and county attempts to limit GM crops. In a press release, Michael Fernandez, executive director of Pew, describes states as having "little choice but to address new policy issues, even before they emerge at the federal level." However, it is arguable that this approach of a futures market in policy might suggest a worrying trend for consumers and other groups seeking greater information and transparency in the way in which GM agriculture is introduced - especially in Europe.

The announcement by Pew follows an interesting event in California, where Santa Cruz County supervisors have recently banned the cultivation of GM crops, approving a moratorium on GM crops within County lines last week. The ban was imposed after the findings of a 9 month study of the laws and risks. According to an article by Genevieve Bookwalker, published in the Santa Cruz Sentinel, there was no opposition to the ban by those in attendance at the meeting, and all written comments showed support for the measure.

Santa Cruz is currently "GM-free," with no GM crops grown within County lines. This is largely attributable to the nature of agriculture in Santa Cruz. The dominant GM crops in the US (and indeed elsewhere) include corn, cotton, and soybeans; whereas the dominant crops in Santa Cruz are berries and lettuce. The moratorium comes as companies have commenced research into crops such as flowers, strawberries, and applies, traditionally grown north of the Pajaro River.

Pew's factsheet highlights an obstacle expected to be faced by Santa Cruz County as well, with the moratorium under threat if a State Bill passes that will remove the authority of local jurisdictions to regulate GM crops. Senate Bill 1056 is sponsored by Monsanto and has been introduced by Senator Dean Florez. The Bill was last amended 19 June, and has a hearing date of 28 June. Patenting Lives will be following its progress.

UK Patent Office Publishes National IP Enforcement Report

The United Kingdom Patent Office has just released its National Intellectual Property (IP) Enforcement Report 2005.

The report is the second since Lord Sainsbury of Turville, Parliamentary Under Secretary of State for Science and Innovation, launched the National IP Crime Strategy (Strategy) in 2004 and plans for a National IP Crime Group (IPCG). The Strategy is described as bringing together industry, government, and enforcers, "widely seen as the way forward" and "already bearing fruit." Plans for further education of the general public is also advocated in the report, "to convince the public that counterfeiting and piracy is not a victimless crime."

The report includes an introduction to TellPatTM, the national IP crime intelligence database. Lord Sainsbury describes TellPatTM as "a crucial strand in our Strategy," with numerous entries concerning IP crime "and the criminals involved." The information, however, comes from not only enforcement agencies, but also industry. The press release accompanying the launch states that more than 500 000 intelligence reports have been received by the Patent Office in the last 9 months.

Members of the IPCG, trading standards officers, and police officers, will all undertake training in the database over the next 12 months as it is introduced into the UK.

Notably, the report continues to concentrate upon initiatives that are motivated by the relationship between industry, government, and enforcement agencies. In this way, such initiatives do not necessarily engage with the public other than through education in "IP crime." By continuing to concentrate on traditional models of property in IP, it might well be that the Strategy utilises a dynamic that threatens to continue the alienation of individual users from the "crime" arguments. On the other hand, genuine "industries" in counterfeiting probably won't attend the classes.

International Plant Genetic Resources Treaty - First Session

The First Session of the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) took place 12-16 June in Madrid. With attendance by representatives of parties to the Treaty, other governments, intergovernmental organisations, non-governmental or civil society organisations, and industry, the First Session was described by the Food and Agriculture Organization (FAO), as making "great progress." The Governing Body came to agreement on several issues before the international body before it, including the adoption of a standard Material Transfer Agreement (MTA), which sets out the conditions for access and benefit-sharing.

The ITPGR was adopted in November 2001, at the 31st Session of FAO Conference, after 7 years of negotiations. The Treaty then remained open for signature by all FAO members and any States that are not Member of the FAO, but are Members of the United Nations (UN) or any of its specialized agencies. There are 103 parties to the Treaty, which entered into force, 29 June 2004, 3 months after it reached the required number of instruments of ratification, acceptance, approval or accession, as per Article 28.

The Treaty's subject matter - plant genetic resources for food and agriculture - is defined in the Treaty as "any genetic material of plant origin of actual or potential value for food and agriculture" (Article 2). In harmony with the Convention on Biological Diversity (CBD), the Treaty is concerned with the conservation and sustainable use of such resources, and the fair and equitable sharing of benefits derived from their use (Art 3).

The First Session of the Governing Body agreed upon the text for a standard Material Transfer Agreement (MTA). The standard MTA has been in development since 2004. The MTA Expert Group met in October of that year to discuss various issues raised by the First Meeting of hte ITPGR Interim Committee (which met for the first time in 2002). At this time, the Expert Group recommended the establishment of an intersessional contact group to draft the standard MTA.

The first meeting of the MTA Contact Group took place in July 2005 and, at its second meeting in April this year, finalised the draft to be considered by the Governing Body at its First Session.

After extended debates at the First Session, the final MTA was adopted with amendments on Friday 16th. The most contentious issue was that of the rates and modalities of payment for benefit-sharing - this is the payment made by a recipient. A Friends of the Chair group was convened to finalise this issue, taking late into the Friday evening to reach agreement. The rate agreed was 1.1% of product sales for commercialisation where that product is not made available to others for further research and breeding. Where the product is sold with no restriction on further research and breeding, the discounted rate of 0.5% would apply.

A excellent summary of the First Session debates is provided by the Earth Negotiations Bulletin.

Seed Vault - Banking Crop Diversity

With advances in agriculture and farming technologies, the common subject matter of those advances is the seeds themselves. What is sometimes not discussed, however, is the way in which crop diversity is influenced not only by the technologies deployed, but also by environmental catastrophes, cultural influences, and political events.

A new seed bank project in Norway is concerned with preserving the genetic diversity in the world's seeds. The Svalbard International Seed Vault, to be managed by the Global Crop Diversity Trust, is to be housed in the permafrost and rock of the remote Svalbard peninsula, about 620 miles from the North Pole. The Trust and the Norwegian government have been working towards a global seed bank since 2004.

The bank will be contained in a reinforced concrete tunnel to be drilled into the rock of a mountain. The natural environment means that there is no need for reliance on artificial refrigeration systems (which can fail). And for even more protection, it is thought that Svalbard's polar bears will act as ready-made guards.

Speaking in a report by the Guardian Newspaper, London, Cary Fowler (Executive Secretary of the Trust) explained that wars in Iraq and Afghanistan, as well as the 1994 genocide in Rwanda, decimate unique crops resulting in the irreversible loss of that genetic diversity: "You can use the word extinction in this case."

It has been suggested in some reports that the facility will run as a kind of bank, in an effort to mitigate concerns regarding national sovereignty over seeds stored in the vault.

Announced earlier this year, the 30 million kroner project was launched this week by the prime ministers of Norway, Sweden, Denmark, Finland and Iceland, and will start accepting "deposits" in 2007.

The "Eurobarometer" on Biotech

European citizens have been characteristically reluctant about the entry of GM food into European agricultural markets. Previous posts have looked at efforts to achieve adequate co-existence regulations ahead of admitting GM food into Europe. However, many have continued to reject the possibility of genuine co-existence of organic, traditional, and GM agriculture in Europe, particularly given the very specific nature of European agricultural practices, where many farms are just a few hectares in size. Despite the efforts towards co-existence on the one hand, complaints of a de facto moratorium on approvals of biotech products in Europe have been brought to the World Trade Organization (WTO) by the United States, Canada and Argentina. The final report of the Dispute Settlement Panel is expected sometime in September this year.

However, this week, a report on the most recent "Eurobarometer" on public attitudes to biotechnology suggests a shift. Prepared for the European Commission's Research Directorate-General (DG Research), the report is based on a survey of 25 000 respondents, undertaken in 2005.

The report concludes that just over half of European citizens are optimistic about biotechnology. Nevertheless, the concerns about GM food remain, with most of those surveyed stating that GM food should not be encouraged. The summary of key findings notes that "resistance to GM food is the exception rather than the rule."

Notably, the increased optimism in biotechnology more widely is largely influenced by a growing confidence in the EU regulation of the technologies. However, the ongoing resistance to GM food suggests that this confidence in regulatory frameworks does not extend to confidence in this area: "The introduction of the new regulations on the commercialisation of GM crops and the labelling of GM food (2001/18/EC) appears to have done little to allay the European public's anxieties about agri-food biotechnology."

Arguably, the very specific nature of agricultural practices, including the important diversity of European agricultural communities and the cultural importance of food, suggests that efforts at co-existence do not seem to be generating confidence in European consumers. Importantly, that lack of confidence is not a sense of alienation from the technology, nor can it be dismissed as merely resistance to the technology and science as such. Indeed, this is borne out by the survey's results in other areas, there being "no evidence that opposition to GM food is a manifestation of a wider disenchantment with science and technology in general."

Rather, public attitudes to GM food in Europe embody very particular issues and concerns specific to farming and food cultures in Europe.

Agbiotech - Does Research Reach Marginalized Farmers?

Research and development into agricultural biotechnology (agbiotech) is treated with both support - as an answer to poverty, economic growth, and food security - and suspicion - as a threat to organic and traditional agricultural practices, public health, and symptomatic of policies of denial of information (inadequate labelling, and so on).

However, what is important about a recent publication in AgBioForum, is the analysis of whether or not the technology and knowledge arising from that research and development is genuinely accessible by and deliverable to marginalised farmers and farmers in developing countries.

The authors are all based at the International Food Policy Research Institute (IFPRI), a research centre of the Consultative Group on International Agricultural Research (CGIAR) concerned in particular with research into food security and agricultural solutions to economic development. David J Spielman (Addis Ababa, Ethiopia) Joel I Cohen (Science, Technology and Education Associates, Potomac, MD) and Patricia Zambrano (Washington DC) argue that public-private research collaboration will be critical in the effort to ensure that agbiotech research benefits developing countries. Of significance is their analysis of the way in which public institutions are isolated in the particular policy and economic context in which this research takes place. Arguably, increased participation of public research in agbiotech would also enhance public capacity in that research.

The importance of public collaboration in research was also recognised by the Union Minister of State for Commerce in India, Jairam Ramesh, in the keynote address at "Agri-biotech Day," Bangalore BIO 2006, earlier this month. Appealing to the industry to "undertake research in the public spirit," Ramesh's comments are of special significance here, highlighting the way in which research cultures can and do benefit from public "investment" in that research - in particular, motivating public interest and a sense of participation.

EU Presidencies Biotechnology Roundtable

An EU Biotechnology Policy Roundtable was held in Helsinki today, ahead of the European mid-term review of the Biotech Strategy, expected later this year. Jointly organised by the 2006 EU Presidencies of Austria (outgoing, January-June 2006) and Finland (incoming, July-December 2006), the event follows a Competition Day (competition policy), organised yesterday in Vienna.

In a press release of the co-organisers of the Roundtable, biotechnology was described as a "core part" of the EU Lisbon strategy. Importantly, the Roundtable considered the need for improvements to the regulatory system for biotechnology, as a key factor for approximating predictability in what is a rapidly advancing and often "incomparable" technology and market. Similarly, greater translation of medical biotechnology developments into consumer benefits calls for "closer integration of user interests or the entire health care system into technology development," said Ms Paula Nybergh, Director General for Technology Policy of the Ministry of Trade and Industry in Finland.

Further information is available from:
Chief Counsellor Pekka Lindroos, Ministry of Trade and Industry, Finland, +358 1606 3597 or pekka.lindroos@ktm.fi

European Patent Troubles

European innovation has been described as "at risk" in a recent article by Chris Jones, if delays to the introduction of the Community Patent continue.

Measuring "innovation" through patent applications, Europe is filing far fewer applications than the rest of the world. Arguably relevant here, however, is the very nature of European innovation cultures, including the existence of very small enterprises (of just a few people), and the possible lack of access on the part of such small players to the rather expensive investment of patent protection. Therefore, underpinning European policy and legal developments is the cost of the system itself and the need to ensure the diversity of players taking advantage of the system. Indeed, Professor Alain Pompidou, the President of the European Patent Office (EPO), is quoted in the Jones as saying, "The systematic use of patents to protect technical innovations is important if the EU's Lisbon strategy is to be a success. One aim of an effective innovation policy should therefore be to develop patent use among European companies, especially small and medium-sized firms." And in an interview at the end of last year, Pompidou stressed the importance of the patent system in this context: "The EPO has a clear role to play in the innovation process in Europe. By securing the transition from invention to innovation and facilitating access to the market-place, the patent system constitutes the key mechanism for such a transformation process."

Despite this support, the Community Patent has had quite a troubled history. Discussions have continued for other 30 years, and yet the Community Patent Convention (CPC) continues to stall. The most recent version, the Amended CPC (1989), is yet to come into force. On the other hand, the Community Trade Mark and Community Design have proceeded successfully.

In 2000 the European Commission revitalised discussion on the Community patent, on the basis that a European wide patent would be a tremendous advantage to European innovation, and published a proposal for a Council Regulation on the Community Patent. In 2003, the Common Political Approach was agreed, but to date this earlier enthusiasm has become somewhat distracted.

The European Patent Convention (EPC) sets out the legal framework for states to come to special agreements concerning translations, as well as the institution of a central court to enforce the Community patent.

In 2005, the EPO pushed the discussions in the direction of the implementation of the London Agreement, which would allow for EPO States to waive their right under Art 65 ("Translation of the Specification of the European Patent") of the EPC. Art 65 gives a State the right to require a full translation into one of that State's official languages. In other words, the patent must be filed in one of the EPO's official languages (French, English, or German). However, at present, the patent must also be translated into the official language of any State in which it is it be protected. Under the London Agreement, the patent would be protected without translation. Therefore, a patent could be filed in German, and nevertheless protected in France despite no French translation (although it may be that courts would require translation in proceedings).

The London Agreement was lauded as recently as yesterday, in a press release of the EPO, where its adoption was explicitly advocated towards saving European firms up to EUR 500 million each year. However, at this stage, the Agreement is yet to come into force. It will come into force only when 8 signatories - including France, UK, and Germany - have ratified the Agreement. Germany and the UK have ratified the Agreement (a consultation on the ratification process was undertaken by the UK Patent Office in 2004). But its progress is stalled until France does so - which by all accounts seems unlikely.

The European Patent Litigation Agreement (EPLA) is a similar exercise in efficiency, providing for the establishment of a European Patent Court and, thus, greater access to the enforcement process for small companies.

Earlier this year, the Commission launched a consultation on future patent policy in Europe, including the future of the Community Patent. Stakeholders and industry submitted their contributions in April and a public hearing is to be held 12 July 2006 when the results of the consultation will be considered.

Update on Monsanto-Mahyco in India

In earlier posts (see June archives, 7 June), the battle between Andhra Pradesh and Monsanto-Mahyco Biotech Ltd (MBBL), the Indian arm of Monsanto, was reported. To re-cap, the government of Andhra Pradesh sought an order from the Monopolies and Restrictive Trade Practices Commission (MRTPC) to lower Monsanto-Mahyco's prices on GM Bt cotton seeds. The MRTPC ordered Monsanto to charge no more than 750 rupees for 450g. Monsanto-Mahyco has appealed to the Supreme Court arguing that the fixing of prices is beyond the powers of the Andhra Pradesh government. However, in an interim order a few weeks ago, the Supreme Court refused to grant a stay of the MRTPC order. A full hearing is to take place 5 July, which will be followed in this discussion here.

Further to this battle, the Andhra Pradesh government hosted a meeting in Hyderabad earlier this month. In attendance were officials from Andhra Pradesh, Madhya Pradesh, Gujarat, Karnataka, Maharashtra, Tamil Nadu, and West Bengal. This meeting produced a common memorandum of understanding to join all states as a party before the MRTPC and Supreme Court of India. The governments of Punjab and Haryana sent letters in their absence, in order to demonstrate their support for the united effort.

An update of events has been published in the Weekly Highlights for India, published by the United States Department of Agriculture (USDA) in a Global Agriculture Information Network (GAIN) report. In that report, it was noted that the state governments have also appealed to the federal government to speak on their behalf before the Supreme Court.

Monsanto is quoted in that report as arguing that prices should be market-driven. This is in response to the questions of Mahyco-Monsanto regarding the marked differences in pricing between India and China, prices being much lower in China. Monsanto has argued that different agricultural practices in China (18 times more seed per acre is required) are also relevant to the market and thus the pricing. According to the GAIN report, "any state intervention would go against the intersts of farmers."

On the other hand, it might also be argued that this kind of intervention is critical to the market. Competition law must be concerned not only with the competition between players, but also with the benefit to consumers and thus to the market itself - one into which new players can enter.

The 5 July hearing promises to be an important development in competition law in India.

BP Joins BIO

In a recent press release, the Biotechnology Industry Organization (BIO), announced the new membership of BP (British Petroleum), becoming the first fully integrated energy company to join BIO.




President of BIO, former Republican Pennsylvania Congressman, Jim Greenwood, stated: "BP joins a growing list of forward-looking companies in BIO's Industrial and Environmental Section, all of whom recognize the key role industrial biotechnology will play in transforming how we produce fuels and consumer products in teh 21st century."

BIO was founded in 1993 through the merger of two Washington-based biotechnology trade organizations - the Industrial Biotechnology Association (IBA), which represently mostly larger companies before Congress and federal regulatory agencies, and the Association of Biotechnology Companies (ABC), which represented emerging enterprises and academic institutions.

According to its mission statement, BIO aims to be "the champion of biotechnology and the advocate for its member organizations - both large and small." Representing over 1100 biotechnology companies, centres, and other organizations, BIO is a strong lobbying group. BIO advocates strong intellectual property rights and patent protection, and is an accredited observer of the World Intellectual Property Organization (WIPO) attending discussions on various issues, including meetings of the Intergovernmental Committee on Genetic Resources and Intellectual Property, Traditional Knowledge and Folklore (GRTKF).

A full list of BIO members is available from BIO's website.

Biotechnology CEO Awarded MBE

The Chief Executive of a biotechnology company specialising in anti-cancer drug development has been recognised in the Queen's Birthday Honours List. Glyn Edwards, Chief Executive of Antisoma, has been recognised as a Member of the Order of the British Empire (MBE), for services to the biotechnology industry.

While at the helm, Glyn Edwards has steered Antisoma through a partnering with Roche. On the potential to risk to biotech through partnering with pharma and the subsequent loss of control, Edwards has suggested that the risk to biotech is mitigated by the investment in longer-term product development: "We think by having this wider, deeper, longer-term relationship covering multiple products we stand more chance of at least one of these products getting to market and being a great success."


The full list of honours is available from the BBC.

US-Malaysia Trade Talks

Monday this week, Malaysia and the US began talks towards a new trade agreement, with hopes of concluding the agreement at the end of this year, before the expiration in mid-2007 of the Bush administration's fast-track authority for legislative approval of international deals. In particular, the US is calling for an effective response to intellectual property piracy in the region, particularly trade in unauthorised copies of DVDs and computer software.

In March, the Prime Minister of Malaysia, Abdullah Ahmad Badawi, launched his plans for Malaysia to become the first developed Muslim nation by 2020. However, according to a report in the Financial Times, the Prime Minister is already facing strong political criticism for his economic reforms, making the passage of the US trade talks somewhat resisted. Further, it has been suggested that a US-Malaysia trade agreement would compromise Bumiputra laws, part of Malaysia's policy of affirmative action for ethnic Malays (motivated in part by the 13 May 1969 Chinese-Malay race riots).

The Second Finance Minister, Nor Mohammed Yakcop, has stated that Malaysia will insist on an agreement beneficial to the country, and will not be pressured by the deadline of 2007: "The FTA is an instrument that if it's beneficial for Malaysia, the country would use it; but if it is no longer in its interest, then Malaysia would not agree."

Generic Omnitrope Approved

Earlier this month the US Food and Drug Administration (FDA) authorised the recombinant DNA human growth hormone, Omnitrope, a generic competitor for Pfizer's Genitropin. Omnitrope is manufactured by the generic arm of Switzerland's Novartis, Sandoz.

This follows an earlier deferral of a decision on the drug by the FDA in 2004, at which time uncertainty regarding scientific and legal issues was cited although no deficiencies in the application were identified. However, at this same time, the drug was approved by the Australian Therapeutic Goods Administration (TGA). European regulators approved the drug earlier this year, when the European Medicines Agency (EMEA) concluded that the drug exhibited comparable quality, safety, and efficacy to that of the Pfizer reference drug, Genotropin. Sandoz filed a lawsuit against the FDA in late 2005 seeking a ruling on the drug.

The recent approval has been described in the Financial Times as a move closer towards generic competition in biological medicines, although in a article in The Boston Globe is less optimistic, suggesting that the relatively simple case of Omnitrope does not make the process clearer for manufacturers of recent blockbuster biotechnology drugs. In that article, Ken Kaitin, director of the Tufts Centre for the Study of Drug Development, suggests growing pressure upon regulators not only from the companies involved, but also from third-party payers. At the same time, however, pharmaceutical and biotechnology lobbyists are resisting the preparation of guidelines arguing that the complexity of biological drugs makes the approval of generics too complicated. Strong lobbying pressure is coming from the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Industry Organization (BIO).

However, interviewed in that same article, Kathleen Jaeger, Chief Executive of the Generic Pharmaceutical Association (GPhA), regards the ruling as showing that the science supports the development of a clear approval process. To this end, legislative changes by Congress are desirable to accelerate the process. The GPhA is working with various policy makers, including Henry Waxman and Orrin Hatch of the Hatch-Waxman Act, to push for legislation to facilitate the entry of cheaper generic drugs into the market.

Consumer Action Against Biotech Foods

The US non-profit and public interest environmental advocacy organisation, the Center for Food Safety (CFS), filed a lawsuit in the US District Court for the District of Columbia this week to compel the US government to impose mandatory labelling and safety reviews of GM foods.

The CFS has been campaigning for testing and labelling requirements for some time. This action follows a history of campaigning on GM foods, including the filing of a legal petition with the Food and Drug Administration (FDA), together with more than 50 consumer and environmental groups, back in 2000. However, the CFS reported that this petition was ignored, as it stepped up its campaign this week. Maintaining that the government should take responsibility for safety tests on GM food, the CFS argues that the FDA should not rely "the very companies that have a financial interest in bringing these biotech crops to market" for an objective and reliable report on the safety of those crops. At present the US does not require independent testing or labelling of GM crops. However, CFS Legal Director, Joseph Mendelson, stated in a Reuters report that this much change: "We think the FDA should be the gatekeeper." He continued that what should be required is "a mandatory process that has rigorous science behind it and public involvement and an actual approval process."

With offices in Washington DC and San Francisco, California, the CFS was established in 1997 by the International Center for Technology Assessment (CTA), to concentrate on campaigns in food production technologies and sustainable alternatives.

The Competition for Science - Private Versus Public?

An interesting exchange took place this week in The Times newspaper, in London. Terence Kealey, Vice-Chancellor of Buckingham University, (the only private university in the United Kingdom) argued that private enterprise is not just contributing to scientific innovation, it is essential for it. Referring to 1940 US government spending, he describes little investment in applied science and pure science, with the lion's share going on defence and agriculture. On the other hand, Kealey presents the private sector (and private money) as the only real means by which research and development in pure science was being undertaken.

However, what Kealey doesn't really consider is the innovation within funding and research cultures themselves. While drawing obvious parallels between wartime spending in the 1940s, and US spending priorities today, Kealey criticises the National Science Foundation model, developed by engineer, Vannevar Bush (who also developed the concept of memex, sometimes considered a predecessor of the World Wide Web), where federal funding is distributed to university scientists through competition for grants. In doing so, he refers to Vannevar Bush's warning "that federal money might not just supplement the private money but might, instead, 'drive it out' and end up reducing the total spent on research." To support this statement today, Kealey notes the 2003 Organisation for Economic Co-Operation and Development (OECD) survey to argue that "only private research powers economic growth." That report suggests that public funding of R&D "crowds out resources that could be alternatively used by the private sector, including private R&D."

This seems to be an extraordinary interpretation, suggesting that public funding is somehow rivalrous with the ventures of private interests in a race for "profitable" results. Using the Human Genome Project as his prime example, Kealey argues that this illustrates the point "that science is not the public good of Bush's book. Science is not a field of endeavour on which taxpayers' money need be spent."

In a letter to the newspaper, Dr AR Williamson identifies quite different issues. Indeed, he suggests that scientific research driven purely by private (and thus commercial) concerns might compromise the breadth of that research and the clarity with which it is communicated and disseminated. Also drawing upon the Human Genome Project, Dr Williamson rightly notes it was not merely a question of profitability that motivated greater public investment in the project, in the light of Celera's interests, but the fear that Celera would obtain patents without producing a complete reference sequence.

In other words, Celera would research to the limit of profitability. Public funding, on the other hand, will investigate to the limits of knowledge.