The Life Science Industry Sector and the Challenge of Upstream

Engagement.

Joyce Tait

The role of regulation in driving innovation

• Three product hurdles – safety, quality and efficacy

• Long product lead times – 15-20 years

• Major attrition of products in the pipeline

• Need for ‘block-buster’ level profits

• Barrier to entry for SMEs

• Dominance of multinational strategies in the development of ‘breakthrough’ technology

GMO- seeds- (foods)- (feeds)

GM & GM-derived foods

GM & GM-derived feeds

GM Food& Feed Regulation

Authoris-ation

Traceability LabellingAdventitiouspresenceexemptions

Liability

Existing liabilitylaws

plus

Environment Liability Law (new)

EU Regulatory System for GM Crops

2001/18

Traceabilityregulation

Traceabilityregulation

GM Food& Feed Regulation

GM Food& Feed Regulation

GM Food& Feed Regulation

Amended2001/18

AmendedSeed regs.

GM Food& Feed Regulation

GM Food& Feed Regulation

Traceabilityregulation

Traceabilityregulation

2001/182001/18

External influences and internal stresses

Products sold to public or private institutional markets (health services, farmers, food industries) rather than direct to consumers – industry managers not used to dealing with ‘the public’

Internal stresses due to maturity of the industry Product pool ‘fished out’ Easy markets satisfied by off-patent products Harder to find competitive new products capable of

attracting blockbuster profits Need for a new innovation trajectory – life sciences as

the saviour of the chemicals-based MNCs But difficult for MNCs to cope with radical change

Quote from Monsanto CEO

“We are overdue for another big splash of revolutionary change… Our creativity needs new outlets… Biotechnology will drive us into the next golden era… in the middle of the 1990s”

L. Fernandez, 1985, Chemistry and Industry, 23, 787-9

Impact of MNC dominance on innovation trajectories

• Types of product– First generation: herbicide, insect and disease

resistant GM crops– Second generation GM crops: nutraceuticals and

functional foods– Problems making money out of seeds– Problems making money out of ‘biological’ drugs– Problems making money out of stem cells

• Societal implications and societal responses

Interpretations of the GM crop debacle in Europe

• The products only benefited industry and farmers - no public benefit

• The public were not consulted about the new technology

• Consumers were not given the option to refuse to purchase GM products

• The regulatory system was inadequate and companies were concealing evidence of harmful effects

Outcomes of the GM crop debacle in Europe

• Research and development on GM crops for European markets is being curtailed

• MNCs are moving their headquarters and research facilities to the USA and newly emerging economies

• European farmers will be disadvantaged in the long run, particularly in a global free market

The lessons being learned in UK

• Members of the public were not consulted early enough about the development of GM crops and when consulted they were not listened to

• For human embryonic stem cell development we have had early and effective public engagement and so far no major opposition

• Therefore we need to move public engagement upstream

The defects and realities of upstream engagement -1

• Ignores the outputs of generations of socio-economic research– Assumes a linear model of innovation– Assumes perfect foresight – Assumes we do not yet know enough about

“the assumptions, values and visions that drive science”

• Assumes that those who wish to engage in the process will be impartial and unbiased

• Assumes a broad public consensus on desired outputs from life science innovation

The defects and realities of upstream engagement -2

• Will block the development of some potentially valuable products

• Will not prevent the development of products that are unacceptable to the public or that harm health or the environment

• Will prevent us from learning from experience

It is fairly clear what we should NOT do.

However, we need more constructive and imaginative engagement from a broader range of social scientists on

what we SHOULD do about public acceptance of radical, breakthrough

innovations.