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Corporate Europe Observer

Industry and the EU Life Patent Directive

Industrial lobby groups are working tirelessly in favour of the proposed EU "Directive on the Legal Protection of Biotechnological Inventions" -- which will extend current European patent law to permit the patenting and thus ownership of life itself. Industry has manipulated the concerns of interest groups formed by patients in order to disguise the fact that the pro-Directive lobby is effectively an industry campaign. The controversial legislation that the European biotech industry is pushing for will open-up life itself as an 'emerging market' to be exploited and commodified. 

"The European Directive that will make it possible genetically to manipulate living organisms will hand control over the genetic heritage of humans, animals and plants to the few industries rich enough to buy the patents, thereby effectively transforming life itself into a commodity to be altered on the whim of partisan commercial interests."
 - Dario Fo, Nobel Laureate

n July 1997, the European Parliament, bowing to two years of intensive industry lobby, adopted the draft "Directive on the Legal Protection of Biotechnological Inventions", despite widespread public opposition. Commonly referred to as the "Life Patent Directive," this controversial piece of legislation would allow for the patenting of genes, cells, plants, animals, human body parts and genetically modified or cloned human embryos. Why did the Parliament, the only directly elected governing body in the EU, not vote according to the wishes of the majority of Europeans who are sceptical or opposed to biotechnologies and ownership of life?[1] What brought about a change of direction by a Parliament that initially vetoed the proposed Directive in 1995? According to geneticist Ricarda Steinbrecher of the Women's Environmental Network, European parliamentarians, by approving legislation that declares that genes could be 'inventions', "sold out to the pharmaceutical and biotech industry."[2]

The Commission's Clean-Up Job

A month later, in August 1997, the EU Commission, the main advocate and architect of the Directive, released its position on the Parliament's draft, with some major changes to many of the 66 amendments. The Commission argues that the changes made were minor and that all of the Parliament's concerns are secured in the text. David Earnshaw of SmithKline Beecham, in defense of the Commission, argues that the changes made were just the "usual legal cleaning-up process."[3] Groups opposed to the Directive however contend that many of the Parliament's proposed 'safeguards' were drastically weakened, or removed entirely in the Commission proposal.
Patenting Life 

"Owning intellectual property over living things is not like owning individual cows or fruit trees, a vegetable garden, a rice harvest, or a fish pond. The distinction can be likened to the difference between owning a bucket (or lake) full of water, and owning the chemical formula for water. A patent holder for water's chemical formula would have the right not only to decide who could have access to a particular lake, but to any water anywhere, and to the use of the chemical formula for any purpose."[4] 

Patents were originally developed to reward the hard work and ingenuity of an inventor by allowing that person exclusive rights over the invention for a certain period of time (usually 20 years). Patents were thus developed as a way to protect the inventor from more powerful interests that could steal the invention and sell it for profit. However, what was an instrument to protect inventors, has increasingly been employed by TNCs to consolidate market control. The patentability of life has opened a whole new area of activity for TNCs, and a new market to establish control over. With standards for patenting already rather relaxed, TNCs are racing to patent genetic material, even if they don't have a clear application for it yet.[5] 

The proposed Directive will 'relax' some of the standards further, by equating 'discovery' with 'invention'. Many patenting regimes, such as that in the US, have already issued patents on life to TNCs despite the fact that there was no inventive step. 

Some 'broad patents' on life have also been awarded to TNCs. These are patents on a whole species, process, or product which grant TNCs control over whole species and technology at the expense of food and health security and biodiversity. For example, Monsanto, through its acquisition of the Agrecetus company, has exclusive rights on all genetically modified cotton and soya plants. "It's not whether or not drug companies need patents to create new drugs, but whether society can survive monopoly control over medical research."[6] 

Industry has long been promoting life patents as a means to protect their investments in research and development of new technologies and products. Pharmaceutical, chemical, and agribusiness companies have been the most aggressive in pushing for life patents, all the while claiming that patents "are a benefit to society."[7] Patents, they argue, encourage companies to invest in research and development of new medicines, pest and drought-resistant crops, and 'environmental products' (i.e. chemicals that can break down toxic wastes). 

However, critics of the Directive, including scientists, farmers organizations, indigenous peoples' rights activists, environmental organizations, church groups, and many others argue that patenting of life only aids corporations to acquire monopoly control over life itself. They question whether it is right that corporations should own the "biological underpinnings of life."[8] They point to the activity of 'bio-prospectors'[9] who have been deceiving indigenous people and stealing their collective knowledge and patenting their medicinal plants, and even their own genetic materials (DNA).[10] 

Whispering Sweet Nothings

The European biotech industry, in its very aggressive lobbying on this issue, has been whispering some key words in the ears of decision-makers -- 'jobs', 'growth' and 'competitiveness'. Their arguments that life patents will help European TNCs to help Europe and Europeans has been largely effective in swaying the Parliament's vote in favour of the Directive.

EuropaBio for instance, the largest biotech industry association with members such as Smithkline Beecham, Novartis, Unilever and Monsanto Europe, has mainly focused on convincing decision-makers that government should support the European biotech industry to be more competitive in the global market, and by so doing, the formula goes, create more jobs.[11] In its 1997 report entitled "Benchmarking the Competitiveness of Biotechnology in Europe," EuropaBio suggests that "creation and preservation of up to three million jobs by 2005" can be achieved if there is a biotech- friendly regulatory environment in the EU. The report compares the patent regulations in the EU to those of the United States, highlighting the US's relaxed regulatory environment with respect to biotechnology as the key to promoting competitiveness of the European biotech industry.[12]

EuropaBio has recently joined a new lobby group set up specifically to push for the life patent directive, called the Forum for European Bioindustry Coordination (FEBC). The FEBC comprises an impressive collection of sector-specific industry groups such as AMEEP (food and feed enzymes), CEFIC (chemicals), CIAA (food), COMASSO (plant breeders), EDMA (diagnostic products), ECPA (plant protection products), EFPIA (pharmaceuticals), FAIP (farm animals), FEDESA (animal health products), FEFAC (compound feed), FEFANA (feedstuffs additives) and GIBIP (plants and seeds). EuropaBio hosts the FEBC Secretariat. The Forum has issued a flood of lobby papers, including briefing papers on specific scientific and legal principles raised in the Directive. Considering the complexity of the issues, and the limited information that MEPs have, such briefings can play a significant role in influencing decisions. Many of these papers offer interpretations of the text of the Directive, suggesting that all of the MEPs concerns are addressed properly in the Commission's draft. The Forum warns "that any weakening of the draft would put Europe at a further disadvantage and will shift the emphasis of research in biotechnology further towards the USA and Japan. It strongly believes that, without patents, there could be fewer or no new treatments, cures, food products, or environmental solutions generated in and adapted to Europe."[14]
Other major industry groupings pushing for the Life Patents Directive have been the International Chamber of Commerce (ICC) and the European chemical industry association CEFIC. The ICC, for instance, through its Commission on Intellectual and Industrial Property, issued a statement in October of 1997 when the Council of Ministers was preparing to take decisions on the Directive. The statement is unusual for the ICC in that it goes into great details concerning the Directive, commenting on specific articles and clauses, and even going so far as to suggest whole passages of text to be included. CEFIC (see also the article on CEFIC in this issue) has issued a number of position papers on the issue of patenting and the Directive, referring to the more simplified laws in the US as a strategic advantage for US corporate domination of the world market in chemicals. The paper suggests that if the European patenting system does not become more business-friendly, the European chemical industry would not be able to compete with the stronger US corporations.[16] It suggests that this would result in a dramatic loss of jobs in the chemicals sector which claims to employ 2 million Europeans.

SmithKline Beecham: Manufacturing Consensus

"Genes are the currency of the future!" - George Poste, Research Director, Smithkline Beecham

 The pharmaceutical giant Smithkline Beecham (SB) has been one of the most aggressive campaigners for the Directive, launching its own lobby campaign even before EuropaBio existed. According to SB lobbyist Simon Gentry, the company allocated 30 million ECU from the start for a pro-Directive campaign.[17]

SB has also actively manipulated and instrumentalised patient interest groups, knowing very well that such groups would be very effective in influencing decision-makers where industry cannot. Its tactics included the direct support of patient charities and organizations (see below).

Having witnessed the efficacy of the environment lobby prior to the initial EP vote in 1995 which ruled against the proposed directive, SB hired the former assistant to the Chair of the EP's Environment Committee, David Earnshaw, as their Director for European Policy Affairs. This enabled SB to not only have better access to the European Parliament and MEPs, but also helped the company to understand the tactics and strategies of the environmental movement in the case of the Directive.

Patient Interest Groups

By far the most influential lobby groups active on the Directive have been the patient interest groups. Many MEPs voted in favour of the Directive under strong pressure from these interest groups in what was described as "the largest lobby campaign in the history of the EU." On the day of the July '97 vote, a number of people in wheelchairs from some patient interest groups demonstrated outside the main hall in Strasbourg, chanting the pharmaceutical industry's slogan, "No Patents, No Cure" in an emotional appeal to Parliamentarians to vote for the Directive.

Perceiving a strong and unified position in favour of gene-patenting from the patient interest groups, MEPs have voted accordingly. Further investigation, however, has revealed that in fact the views of the majority of patient interest groups were not expressed, and that those that were vocal were largely co-opted and bankrolled by big pharmaceutical companies such as Smithkline Beecham. Companies like SB have approached these groups and presented themselves as agents who care about their needs and are actively seeking cures for their maladies. They highlight the need for legislation such as the Directive in order to create a climate in which development of the much needed medicines can take place freely. Painting a picture in which patents on life correlates directly with cures for all known diseases, industry has sought to blackmail Parliament and these interest groups with the ultimatum "no patents, no cures." While most patient interest groups did not buy in to the corporate dream, some rather influential groups have been co-opted.


The Genetic Interest Group (GIG), a UK umbrella organization, and the European Alliance of Genetic Support Groups (EAGS), have both been very active in lobbying for the Directive. This, however, was not always the case. Up to 1995 vote where the European Parliament voted to reject the draft Directive, GIG and EAGS, through their main spokesperson Alastair Kent, were both against the patenting of genes. However, this changed when SmithKline Beecham began making donations to GIG. Alastair Kent was soon found lobbying aggressively for the Directive, still in the name of both organizations, with new and considerable financial resources to finance a strong lobby initiative.

GPC Market Access

SmithKline Beecham's support for Kent also included the hiring of professional consultancy GPC Market Access to help with the lobby campaign. It was during this time that the slogan, "Patents for Life" became the title for a series of lobby documents issued in the name of EAGS. With the assistance of GPC Market Access, a massive disinformation campaign was launched which tried to inflate the emotions of decision-makers by talking about saving lives, ending hunger and creating jobs.

Another consultancy group, Adamson Associates, was also recruited by the biotech industry to work on the Directive, and has been engaged in similar activities. Adamson also organized an information event on human gene-patenting in Strasbourg in January 1997, which was presented as an event of patient organisations.[18]

Patient Groups Clarify Their Positions

After the 1997 vote in which the efforts of Kent and his well-oiled lobbying machine helped to sway the decision, some patient interest groups became aware of the fact that his activities in the name of GIG and EAGS were in fact contrary to their own views on the Directive. After this information emerged, the Chair of GIG, Joanie Dimavicius, issued a letter restating the views of the group, which is clearly against gene-patenting.[19] Patients have now woken-up to the fact that they have been manipulated and abused by industry and industrial lobbyists, and have since restated their positions against the patenting of genes.
Food and Health Sectors 

As the world's food supply and health services are concentrated more and more into a corporate oligopoly in which a few TNCs make decisions about what crops to plant (i.e. bio-engineered instead of traditional varieties) what drugs to develop, what price to charge for them, etc., people are increasingly at the mercy of these TNCs for their basic survival needs. 

The top 10: 

• agrochemical corporations accounted for 82% of global agrochemical sales in 1996. 

• seed corporations control approximately 40% of the global commercial seed market. 

• pharmaceutical companies control approximately 36% of the world market, and the top 20 control 57%. 

• the top 10 veterinary corporations control approximately 63% of the market.[20] 


"Advances in both medical knowledge and plant variety have not been driven by venture capitalists but by the pursuit of knowledge, the desire to heal, the need to feed and sustain."[21]

Just how successful this massive industry campaign has been will be revealed when the European Parliament votes on the Directive in May. The Directive, if passed, would give TNCs a broad license to loot and possess exclusive rights over the world's genetic material.

While intellectual property and life patent law is a relatively new legal frontier, industry is working hard to make sure that the legal and legislative frameworks developing on these issues are in the interests of business. Teamed with the European Commission in its effort to "nurture the European biotech industry,"[22] the above-mentioned groups have been able to strongly influence this process.

The European Commission and industry have been pushing the legislation forward rather quickly, arguing that the European biotech industry cannot afford to wait long to establish itself firmly as a contender in the world market. Responding to the lack of public acceptance of biotechnology in Europe, Dennis Purcell, Managing Director for Life Sciences for investment bankers Hambrecht and Quist, said he was not concerned about potential effects on biotech companies."I think the United States went through the same process ten years ago when there were a lot of questions in people's minds about what biotechnology was. Lobbying could help educate," he said.[23]

Industry has manipulated public opinion through forcing biotechnology products into 'unwilling' markets and through political channels. By strategically forcing biotechnological products into the world's food supply, companies such as Monsanto argue that biotechnology and patents on life are inevitable and resistance is futile. "Our genes are incorporated into approximately 19 million acres around the world -- covering an area larger than Switzerland and the Netherlands combined," says Tom McDermott, Monsanto's European head of public affairs. "Can Europe at this point really resist?"[24]

The Directive in Perspective 

1988 - The European Commission introduces the European Union Directive for the Legal Protection of Biotechnological Inventions to the European Parliament. 

1995 - On March 1st, the European Parliament rejects the draft Directive for the Legal Protection of Biotechnological Inventions against the will of the European Commission and the Council of Ministers -- the only time the Parliament, to date, has used its veto powers (a power given to it by the Maastricht Treaty) to reject a draft EU legislation. 

1996 - The European Commission reintroduces the proposed Directive, almost identical to the previous one, to the European Parliament. The Commission claims that in the new draft, the Parliament's concerns have been taken into account. 

1997 - On July 16th, the European Parliament adopted the draft Directive with 66 amendments. During the vote, the halls in Strasbourg were filled with corporate-sponsored patient interest groups, wearing T-shirts saying, "No Patents, No Cures" and "Patents for Life." 

1997 - In August the European Commission submits a new draft of the Directive claiming to have made only minor changes. In fact, the text departs considerably from many of the critical concerns and amendments raised by the European Parliament. In November the European Council concludes its negotiations regarding the Directive, and a majority vote for an amended text which promotes patents on life. 

1998 - In May of this year, the European Parliament will vote again on the Commission/Council proposal.

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1. International Research Associates conducted a poll for the European Commission in which 61 percent of those polled thought that biotechnology poses a risk and believed that it can result in dangerous new diseases. These fears were not necessarily based on ignorance about the issues say the surveyors: "It is rather the case that those who are the most ignorant on the subject tend to be less concerned. Being more informed does not necessarily mean being less worried." | Back to Text |

2. Sarno, Niccolo. Poll Finds Europeans Mistrust State And Science. IPS, Brussels, 6 October 1997. | Back to Text |

3. Coss, Simon. Campaigners seek MEPs' Support in Final Bid to Halt Genetic Patenting Law. European Voice, 9-15 April 1998. | Back to Text |

4. Rural Advancement Foundation International. "Enclosures of the Mind: Intellectual Monopolies". Page 7. | Back to Text |

5. "They (the genome companies) systematically patent everything which could be of any value at all. If this is not possible they withhold large quantities of genetic information which could be of public value, until such times as better conditions for its use appear." Le Monde Diplomatique, March 1997, pp. 12-13. | Back to Text |

6. Rural Advancement Foundation International. "No Cure for Patents: Biotech Patents Distort and Discourage Innovation and Increase Costs for Dubious Drugs." News Release -- European Biotech Patent Directive, RAFI, 2 July 1997. | Back to Text |

7. EuropaBio, "The Importance of the European Biosciences Industry." <http://www.europa-bio.be/publications/patent03.htm> | Back to Text |

8. Genetic Resources Action International. "Patenting, Piracy and Perverted Promises. Patenting life: the assault on the commons." GRAIN, Page 2. | Back to Text |

9. Bioprospectors -- "Companies and individuals who explore, extract and screen genetic diversity and indigenous peoples' knowledge for commercially-viable genetic resources." From "Enclosures of the Mind: Intellectual Monopolies. A Resource Kit on Community Knowledge, Biodiversity and Intellectual Property." Published by the Rural Advancement Foundation International, page 8. | Back to Text |

10. Currently, some cell lines of indigenous people have been patented by TNCs. In most cases, the people were not told that they were granting the ownership of their cell lines to corporations. | Back to Text |

11. EuropaBio is a result of the merger of the Senior Advisory Group on Biotechnology (SAGB) and the European Secretariat for National Biotechnology Associations (ESNBA) in 1996. SAGB was one of the chief architects of the Directive. For more on the SAGB and on Europa Bio, consult "Europe Inc.: Dangerous Liaisons Between EU Institutions and Industry", pages 35-37, as well as the Corporate Europe Observer, October 1997, p. 6. | Back to Text |

12. FEBC, FEBC's Views on the "Directive on the Legal Protection of Biotechnological Inventions", page 3. | Back to Text |

13. Ibid, page 4. | Back to Text |

14. Ibid, page 3. | Back to Text |

15. "The ICC works closely with intergovernmental and non-governmental organizations involved in intellectual property policy, such as the World Intellectual Property Organization (WIPO), the World Trade Organization (WTO), the World Customs Organization, the European Commission, the International Association for the Protection of Industrial Property (AIPPI), the Licensing Executive Society (LES),and the Association Europeenne des Industries de Marques (AIM)." ICC Commission on Intellectual and Industrial Property, <http://www.iccwbo.org/Comm/html/property.html> | Back to Text |

16. "Western Europe is the world's largest market for chemicals. The European chemical industry should, therefore, operate with an advantage over other regions whose home markets are not as significant. However, the difficulties in securing effective patent protection in the region mean that this market is not as easily exploitable by high technology business as it should be, putting European-based chemical companies at a disadvantage to their American counterparts, for example." Page 3. | Back to Text |

17. ECOBP,"The Big Mirage: The Misuse of the Patient with Hereditary Diseases Before the EP's Vote in 1997," an ECOBP Background Paper, March 1998, page 4. | Back to Text |

18. Ibid, page 7. | Back to Text |

19. GIG, Position on the European Biotechnology Directive, 19 November 1997. | Back to Text |

20. Rural Advancement Foundation International (RAFI) Communique, "The Life Industry 1997". Nov/Dec 1997, page 1. | Back to Text |

21. Simpson, Alan. "The Theft of Our Souls". The Guardian, 11/7/97. | Back to Text |

22. Ernst & Young. "European Biotech '97: A New Economy." Ernst & Young International. April 1997. Page 67. | Back to Text |

23. Reuters. "Europeans Don't Trust Biotechnology, Study Finds." Reuters [WS] via Individual Inc. London, June 25. | Back to Text |

24. BusinessWeek. "Seeds of Discontent: The Pros And Cons Of Gene-Spliced Food." 2 February 1998, p.62-63.| Back to Text |

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