Pharmaceuticals

Introduction

The pharmaceutical industry is one of the most research-intensive industries in the world. With two-thirds of the world’s known diseases still lacking medication to treat them, the pressure to discover new and better drugs is mounting. Natural resources have historically played an important role in the fight against disease. Despite the emergence of alternative methods for developing and producing pharmaceuticals, it is unlikely that natural resources will become totally obsolete. Furthermore, the potential for new discoveries lies within the realm of biodiversity which to date remains undiscovered. For the pharmaceutical companies biodiversity provides opportunities which will help sustain the industry.

Understandably, pharmaceutical companies have come under increasing pressure from governments, NGOs, investors and other stakeholders to manage their environmental impacts addressing issues such as the effects of bio-prospecting on biodiversity. Because of the nature of the industry, where the source of discoveries is often in biodiversity rich areas which at the same time face the greatest development challenges, the Convention on Biological Diversity (CBD) applies to processes across the industry, from research and development through to marketing and distribution. It is therefore important that pharmaceutical companies identify ways to contribute positively to biodiversity.

Uses and Impacts on Biodiversity

The pharmaceuticals industry develops, manufactures and sells diagnostic substances and medicinal products in the form of tablets, capsules, ointments, solutions, suspensions and powders. Through its operations, the industry can impact in a range of ways which are summarised below.

Research and Development

Plants, fungi, marine organisms, insects and animal genetic resources are among the wealth of sources from which medicinal products have been discovered and developed. Yet it is estimated that less than 15% of higher plant species have been investigated for their potential medicinal use. Consequently, the opportunities for further research and discoveries from the diversity of species on earth are substantial.

While the drive to sample and discover new species, molecules and applications to medicine provides the industry with many opportunities, there are numerous risks associated with poorly managed processes.

One of the leading challenges for bio-prospecting, or the search for new products based on naturally occurring organisms, relates to fulfilling the objective of the CBD which stipulates that any benefits derived from biodiversity are shared equitably. Most responsible companies will comply with export licensing and royalty payment requirements for any species which they acquire or use in their research and development activities. However, there is a real danger that even the best intentions are not ultimately followed through in the originating country and that economic benefits do not reach the local communities where a discovery originates.

A further consideration relates to developing production methods which require sourcing inputs for medicines through cultivating or harvesting natural products. Over-harvesting not only damages local economies in the long term, but can cause irreversible ecological damage depriving other species from a resource which they depend on. Cultivation which transforms ecosystems, for instance through replacing forested areas with agricultural fields, will also have a detrimental effect on the biodiversity, particularly where monoculture replaces a rich selection of flora and fauna.

The issue of Genetically Modified Organisms is a hotly discussed topic which the Cartagena Protocol on Biosafety aims to address and ensure that adequate levels of protection are bestowed on the transfer and handling of living modified organisms (LMOs). Cultivating LMOs may induce genetic dilution into areas which are highly biologically diverse when genes from the LMOs mix with other crops. As the overall effects of the introduction of LMOs into an environment are as yet unknown, precautionary approaches are recommended to avoid accidental and potentially irreversible damage to the biodiversity of a region.

Supply Chain

Purchasing decisions will ultimately impact on biodiversity. Even though these effects may be indirect in terms of a company’s environmental impacts, they can be substantial. For the pharmaceuticals industry, these impacts can be classed under two broad categories:

Procurement: Natural resources provide raw materials for pharmaceutical products as well as their packaging. Additionally, companies will use a multitude of other products in order to conduct their business which effect biodiversity.

The use of plants or animals or their derivatives in medicines can place demands on particular species or entire ecosystems which will need careful management if their supply is to be sustained. For instance, developing schemes which encourage responsible, restricted harvesting or sustainable agricultural practices may help to secure future populations of a particular species and maintain healthy habitats. Further information about managing supply chain management can be found here.

Distribution and Transportation: Import of raw materials and export of pharmaceutical products is a global operation demanding long-distance transportation. The effects of transporting materials, removing waste and distributing pharmaceuticals can constitute serious environmental impacts. Burning fossil fuels is a known contributor to climate change where the impacts on biodiversity are only beginning to be understood.

Production processes

Through the manufacture of pharmaceuticals solid wastes, effluents and atmospheric emissions may be released, all of which can have serious detrimental effects on biodiversity. Click here for a table summarising common production processes, their environmental effects and the links to biodiversity. Managing these impacts not only constitutes a legal requirement, but can also reduce negative impacts on biodiversity.

Site Management

Pharmaceutical companies are likely to hold or manage a substantive amount of land which houses anything from offices and factories to laboratories. Poor management of land holdings without consideration for the surrounding environment not only leads to biodiversity loss as habitats are fragmented or lost, but can impede developing good community and government relations. More information on managing sites for biodiversity can be found here.

What You Can Do

While many approaches to positively contributing to biodiversity can be shared across industries, there are specific opportunities for the pharmaceutical industry to develop. Due to the range of direct and indirect impacts which pharmaceutical companies can have on the environment, an initial assessment of and commitment to eliminating negative impacts will provide a principal framework for addressing biodiversity impacts. Different approaches are needed to address historic versus present and future risks for a company, and this section outlines just some of the ways in which pharmaceutical companies can manage and make a positive contribution to biodiversity.

Research and Development

The Convention on International Trade of Endangered Species (CITES) and CBD have provided the frameworks for a number of guidelines to help companies in the acquisition and use of natural resources for the development of new pharmaceuticals. See for example, Bonn guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits, Addis Ababa Principles and Guidelines for the Sustainable Use of Biodiversity.

Ensuring Benefit Sharing

Over the past years progress has been made towards developing programmes which aim to ensure that the benefits of biodiversity discovery and use flow to the communities where these discoveries originate has been made. The Indigenous People’s Biodiversity Programme developed with support from the United Nations Development Programme (UNDP) has helped to build capacity of indigenous people to contribute towards research.

Programmes which help to raise awareness about the value of biodiversity and share knowledge on its sustainable use and management can help to conserve biodiversity as well as lead to new discoveries. Successful programmes involving local people in the search for new pharmaceuticals have also been shown to motivate communities to conserve habitats.

In addition to ensuring financial rewards are directly fed into the communities which pharmaceutical companies benefit from, successful programmes can help to develop sustainable livelihoods through some of the spin-off effects of conservation initiatives such as agriculture or tourism.

Supply Chain Management

Purchasing decisions in pharmaceutical companies are initiated through the research and development process where the source of materials is largely determined. Taking account of biodiversity impacts of raw materials at this stage will help to reduce long term reliance on unsustainable sources and negative impacts on biodiversity. Positive effects can be derived through engaging suppliers of all sorts of products in dialogue on biodiversity and developing collaborative efforts which address issues such as sustainable sourcing. More information about supply chain management can be found here.

Production Processes

In order to manage impacts from pollutants, chemicals emitted at each stage of the production process need to be dealt with appropriately. The management of waste is highly regulated, and pharmaceutical companies can employ a number of strategies for minimising emissions including:

• Material substitution
• Process modifications
• Good operational practices
• Recycling, recovering and reusing
• Pollution prevention research

These measures will have many benefits for the company and environment, with biodiversity gaining through the reduced risk of damage.

Site Management

Companies have the potential to positively impact the environment through good management practices of land-holdings. For further information on how to develop and implement Company Site Biodiversity Action Plans please click here.

Benefits

Within the Pharmaceuticals sector, a host of opportunities exist to help with the implementation of the CBD and contribute positively to biodiversity. As a constituent element of sustainable development, addressing biodiversity can lead to a host of other benefits such as economic and social development – potentially leading to a healthier society. This not only can help to secure market opportunities, but can have far-reaching reputational benefits. Mainstreaming biodiversity into operations can develop corporate capacity to manage risk. Pharmaceutical companies engaging with biodiversity can make a real contribution to the quality of life of society.

Resources

Publications
Kate, K.T. & Laird, S.A. (2000). Chapter 3: Natural Products and the Pharmaceutical Industry. In: The Commercial Use of Biodiversity – access to genetic resources and benefit sharing. Earthscan Publications Ltd, UK.
Cunningham, A. B. (1993). Ethics, Biodiversity and New Natural Products Development. Report published by the WWF.
EPA Office of Compliance Sector Notebook Project: Profile of the Pharmaceutical Manufacturing Industry, September 1997. EPA is the head environmental protection and regulatory body in the US.
Ecological Assessments and removal technologies for pharmaceuticals in the Environment, Rempharmawater, 2003.
Biodiversity: Its importance to Human Health, A project of the Centre for Health and The Global Environment, Harvard Medical School (2002).
The Environmental Agency’s position statement on pharmaceuticals can be found here.

Information

International Cooperative Biodiversity Group (ICBG) is a group devised to integrate pharmaceutical discovery with economic development and biodiversity conservation.

European Agency for the Evaluation of Medicinal Products is a co-ordinating European body providing information about and evaluation of medicinal products, research and development programmes throughout the EU to users and health professionals.

Conventions

CBD, Convention on Biological Diversity
The Cartagena Protocol on Biosafety has published the Cartagena Protocol on Biosafety for LMOs
CITES

CITES UK

Photocredit: Peter Wakely/ English Nature, Mark Mather/studing butterflies