An initiative to develop consensus-based industry standards to identify and define green chemicals and process technologies is underway. The move is a helpful step toward more sustainable practices for the chemical and pharmaceutical industries, but it raises larger questions. Can the pharmaceutical industry be more proactive in becoming green? And can regulatory authorities do more to encourage process improvement for green pharmaceutical manufacturing?

Before considering these questions, first the news. Robert Peoples, director of the American Chemical Society’s (ACS) Green Chemistry Institute, provided an update on the initiative for green-chemistry standards Aug. 16 at the ACS National Meeting in Washington DC, according to a recent article by Chemical and Engineering News (C&EN), an ACS publication. C&EN reported that nearly 50 stakeholders are helping to establish the green standard, which is expected to be completed in draft form for public comment by the end of this year. The standard will set criteria for chemical producers and users to evaluate the environmental impact and sustainability attributes of chemicals and their derivatives, according to the article. The ACS, chemical and pharmaceutical companies, the American Chemistry Council (which is the US-based trade association representing chemical manufacturers), nonprofit environmental organizations, and academia are participating in the process to develop the standard. The aim is to have the standard certified by the American National Standards Institute (ANSI) in June 2010. ANSI is a nonprofit association that functions as an administrator and coordinator of the US private-sector voluntary standardization system.

Voluntary green standards are a good step and represent an approach taken by other industries. A prominent example is the Leadership in Energy and Environmental Design (LEED) certification and rating system for the construction and building industry. Developed by the US Green Building Council (USGBC), LEED provides building owners and operators a framework for identifying and implementing practical and measurable green building design, construction, operations, and maintenance solutions. USGBC consists of 20,000 member companies and organizations and 100,000 LEED-accredited professionals, according to USGB.

Efforts such as LEED and the proposal for green-chemistry standards are laudable and provide an important structure, but standards, alone, are an incomplete solution to encourage more sustainable practices. The fundamentals of green chemistry, as enumerated in the 12 Principles of Green Chemistry, such as atom efficiency, byproduct reduction or elimination, the use of renewable resources in raw materials, and other process efficiencies that can result in economic and environmental benefits, are well understood by process chemists. The challenge for the pharmaceutical industry is to create a continuing business case for green manufacturing.

Consider this. Generic drugs account for roughly 60% of the US prescription drug market, according to a recent analysis by IMS. The average number of new drugs approved in the US (as measured by the number of new molecular entities and new biologic license applications approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research) between 2005 and 2008 was 21. Even if every manufacturing process for every new drug were to be a green process, only a handful of drugs would be manufactured via sustainable practices. If we want to truly “green” the pharmaceutical industry, we have to consider how to realistically apply more sustainable approaches not only in the manufacturing processes of new products, but also for products throughout the life cycle.

So here is a solution. Why not provide innovator-drug companies additional year(s) of product exclusivity if the manufacturing process for a particular drug may be classified as green. This approach would provide incentives for green approaches not only in new drug development, but would also encourage continual process improvements throughout the life cycle of a drug product. The pharmaceutical industry now employs generic-drug defense strategies, whether it be reformulating for product-life extension, developing pediatric formulations for additional exclusivity, and designing intellectual property and patent estates. Why not use the the economic lure of additional market exclusivity to encourage green manufacturing and, in the process, truly cement a scientific culture for green manufacturing?

In turn, provide generic-drug companies exclusivity incentives for improving to green manufacturing. Currently, generic-drug companies with “first-to-file” status for an abbreviated new drug application are rewarded with a 180-day marketing exclusivity period. First-to-file status recognizes a generic company seeking to develop a generic drug for which there is no generic-drug competition as being the first to file for a Paragraph IV certification that challenges a particular patent for the drug. Such a system rewards adept legal strategies of individual companies and encourages resource allocation to support those strategies. Wouldn’t it be better to incentivize companies toward scientific progress, such as in green-manufacturing, rather than simply encouraging adroit legal maneuvering?

Concerns over costs and regulatory acceptance for changes to a manufacturing process now provide a disincentive for companies to modify manufacturing process. So regulatory authorities also need to play a role through the timely review of regulatory filings and by showing a receptivity toward such changes, a mindset that is consistent with the science-based approach in quality by design.

So voluntary green standards are a good first step, but let’s push the envelope further. There will always be technical challenges to overcome in green pharmaceutical manufacturing, given the complexity of the molecules used as active pharmaceutical ingredients in terms of the synthesis itself and related purification. But let’s support the scientific efforts to overcome those challenges by providing a meaningful economic and regulatory framework to do so.