Biotechnology – Six questions

_____________________________

Speech (10) on the Ninth Malaysia Plan
by Lim Kit Siang  
________________________________

(Parliament, Monday) :Let me refer to Chapter 6 of the 9MP on “Biotechnology for Wealth Creation”

Firstly, the Government has ambitions to use biotechnology to tap the country’s rich biodiversity found in our forests and farms. Biotechnology covers a range of techniques such as tissue culture, techniques to identify genes and genetic engineering. The National Biotechnology Policy that has been adopted is not clear as there are many statements that are more hype and full of high expectations rather than based on fact and knowledge. 

There are two key issues:

(a)  foreign investors are being wooed to develop the bioetchnology sector so how are we ensuring that we properly regulate access to our biological resources and traditional knowledge, and avoid “biopiracy”.  

(b)  Why is there very little mention and emphasis on biosafety and its importance, in the chapter on biotechnology? The concerns raised here are with regard to genetic engineering where genes are transferred between different species and genetically enginnereed seeds, plants, microorganisms and animals are produced.  Currently there is genetic engineering research being done on papaya (up to field trials), rubber, oil palm, rice.

All the efforts to promote biotechnology (with ambitions in genetic engineering and recently announced plans for nanotechnology) and the adoption of the National Biotechnology Policy are being done without a biosafety law in place, insufficient expertise to assess hazards and risks associated with the technology

While Malaysia is a Party to the Cartagena Protocol on Biosafety, Malaysia has yet to have a national Biosafety Act in place, which could help protect the country from the potential environmental and health risks of genetic engineering. There is a mention of such a law in Chapter 6.  Reality: The Biosafety Bill has been fought over among the various ministries for almost 7 years.  Where is that Bill now?

Meanwhile, the international community has recognized that there are potential risks to human health, the environment and socio-economic concerns, in relation to genetic engineering. It is thus crucial that biotechnology development must be balanced with appropriate biosafety measures.

This balance has already been recognized by the Prime Minister, who in his speech at the opening session of the International Conference on Biodiversity: Science and Governance, Paris, 24^th January 2005, “Biodiversity for the benefit of present and future generations”, clearly stated:

“Malaysia has identified biotechnology as an important source of growth, particularly given the existence of abundant biological resources in the country. Indeed, biotechnology is capable of creating new sources of wealth and additional income. We would welcome not only local but also foreign investment in this sector. However, while Malaysia is aware that biotechnology holds much promise, we are also concerned that biotechnological products should not pose any threat to the environment, or to human health and safety….”.

“The international community has recognized the potential hazards and risks of genetic engineering. The principle of precaution underpins the Cartagena Protocol on Biosafety as well as its parent convention, the C.B.D. [Convention on Biological Diversity]. The First Meeting of the Parties of the Cartagena Protocol was held in Kuala Lumpur last year [2004]. Malaysia is also the current president of the Seventh Conference of the Parties (C.O.P.) to the C.B.D.. We intend to use the remaining term of our presidency to focus on the question of effective implementation of both the C.B.D. and the Biosafety Protocol.”

But this is not reflected in the 9^th Malaysian Plan.

Secondly. It  is clear that the nation’s biodiversity is expected to play an important role in developing the biotechnology sector. The local knowledge in traditional/ complementary medicine is also mentioned as a focus to “develop leads for the pharmaceutical and nutraceutical industries”.

What safeguards are being put in place to ensure that our biodiversity and traditional knowledge are not stolen (a phenomenon known as ‘biopiracy’), and that benefits are equitably shared between foreign researchers/companies and Malaysia if commercialization occurs?

As the Prime Minister said in Paris, 2005, “As one of the “megadiverse” countries, Malaysia has a special interest in this issue (access and benefit-sharing) because any unregulated access to biological resources threatens biodiversity. It should be accepted as a matter of principle that commercial benefits should be fairly and equitably shared with the providers and users of the biological resources. Although fraught with difficulty, we must seek the right balance and correct formula to cater for national rights and international obligations in access and benefit-sharing”.

Work on an access and benefit sharing bill started 7 years ago at the same time as the Biosafety Bill.  What is the status?

Thirdly.  What are the measures being undertaken by the Malaysian Government to safeguard our biodiversity, and to protect our citizens and the environment from genetic engineering hazards, as there is clearly a lack of regulatory frameworks on these matters? Although mention is made in the 9^th Malaysia Plan that the government is in the process of formulating and enacting these laws, these have been more than 7 years in the making. Is the government expediting the process to ensure that the Biosafety Bill and the Access and Benefit Sharing Bill are enacted as soon as possible?

Fourthly.  On page 161, under the section on ‘Private Sector Participation’, it is stated that during the 8^th Malaysia plan period, “measures were taken to foster closer international collaboration in the field of biotechnology. A number of initiatives contributed towards developing domestic capability in key platform technologies to produce high value added products and generate intellectual property (IP)”. What sort of intellectual property was generated and over what?  Who owns those IP – domestic or foreign entities?  Are there adequate safeguards in place to ensure that our Patents Act, which does not allow the patenting of animals and plant varieties is not contravened?

As mentioned by the Prime Minister in Paris, 2005, “Another related issue concerns the increasing scope of patents and other IP claims over biological resources as well as their parts and genetic make-up. There are many unresolved dimensions in this area, with serious socio-economic and ethical implications. These issues need to be examined and carefully considered by both scientists and policy makers, with a view to providing clear and fair rules and guidelines.”

Fifthly.  The 9^th Malaysia Plan states, “Biotechnology projects are confronted with issues such as high risk, substantial upfront investment and stringent regulatory compliance”. A 2002 study of 51 biotech centers in the U.S. by the Brookings Institution revealed that it often takes a decade or more to develop biotechnology-based products and perhaps only one in 1,000 patented biotech innovations produces a successful commercial product.

According to an Ernst & Young report (May 2004), publicly traded biotechnology companies in the US have been estimated to have suffered cumulative losses of over USD 40 billion from 1990 to 2003. Fourteen years ago, net losses at the 194 US biotechnology companies then listed publicly amounted to USD 900 million. In 2003, 314 public companies posted total losses of USD 3.2 billion, which was better than the USD 9.4 billion total loss in 2002 when Ernst &Young says merger- and restructuring-related accounting charges made losses unusually large.

As biotechnology is clearly a risky venture, and is highly capital-intensive, is Malaysia really ready for this? Public funds will be spent, and much is at stake – will these be better used in other less risky ventures?

Sixthly.  Page 163 of the chapter states: “Other agro-biotechnology activities that will be promoted include biopharming, the use of transgenic plants or livestock to produce high-value proteins”. Is the government aware that such applications are extremely controversial and that there is huge concern about the safety aspects? Two US National Academy of Sciences’ committees have already criticized the use of food crops for pharmaceutical production due to concerns that pharmaceutical contamination of foods could pose health risks.

Will food crops be used and will these be planted in the open? If transgenic food crop plants producing proteins such as pharmaceuticals, vaccines or industrial chemicals are planted in the open, the likelihood of contamination is very great, which could mean that our food supply could be threatened.

Such an incident already happened in the US, in 2002, where 500,000 bushels of soya had to be destroyed, because a transgenic maize plant producing an unapproved pig vaccine had contaminated the soya harvest. The company involved, ProdiGene, was fined USD 250,000 by the authorities. ProdiGene also agreed to post a USD 1 million bond and reimburse the US Department of Agriculture for the costs, which could be several million dollars, involved in disposing of the contaminated crops. Is our regulatory system ready to deal with any accidents such as this?

Furthermore, a recent report (Plant Made Pharmaceuticals – Financial Risk Profile, 2006 by Friends of the Earth and US Public Interest Research Group) indicates that attempts to employ transgenic plants as a production platform for such “plant-made pharmaceuticals” (PMP) have foundered despite 15 years’ of field trials and huge infusions of capital.

Companies have failed to bring even one PMP through the FDA’s drug approval process due to technical difficulties unique to the plant-based system – immunological issues, problematic extraction of the drug from plant tissue, and inconsistency in drug quality and yield in differing environments.

Four biotech companies are leery of PMPs - industry leader Monsanto closed its PMP subsidiary Integrated Protein Technologies in October 2003. Novartis Pharma, a major biopharmaceutical producer, is skeptical of the transgenic plant platform and recently committed USD 6 billion to further development of traditional fermentation systems. Smaller players that concentrate on PMP production have gone bankrupt (CropTech & Large Scale Biology, tobacco). Epicyte Pharmaceutical, once a leader in pharma corn development, also went bankrupt and was taken over by Biolex in April 2004; Biolex utilizes the aquatic plant duckweed to make experimental biopharmaceuticals in contained and controlled bioprocessing facilities.

(03/04/2006)