Change is ever-present, whether one is studying natural systems, social norms, or business practices. Change is not self-propagating or self-motivated but originates and moves in one direction or another due to pressures (internal and external) often referred to as drivers. For the purposes of this discussion, identified drivers are put into two categories: drivers to safer alternatives and business drivers. This post will delve into drivers to safer alternatives; business drivers will be discussed in a following post.
Drivers to Safer Alternatives
Factors behind the movement towards sustainability in general – and green chemistry in particular – can be divided into the following primary groups: regulatory agencies, members of a supply chain (both upstream and down), knowledgeable and connected consumers, influential non-governmental organizations (NGOs), and investors.
Regulations and Regulators
The regulatory landscape is a complicated one, where federal, state, local, and international systems abound. The first challenge is knowing pertinent regulations exist and how they are applied within a particular industry. Once identified, they require thoughtful interpretation to find ways that they may be applicable to a product or process, even when exceptions and exemptions are specifically called out. For example, the European Union’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) legislation appears to not impact pharmaceuticals since substances used in medicinal products following regulation (EC) No 726/2004 [Lit 26], Directive 2001/82/EC [Lit 27] and Directive 2001/83/EC [Lit 28] as amended are exempted (Article 2 paragraph 5 of Regulation (EC) No 1907/2006). However, chemicals used in the manufacture of, but not contained within, the finished product may be subject to the regulation.
The U.S. EPA lists areas of environmental regulation that impact the pharmaceutical and medicine manufacturing sector (NAICS 3254). These include greenhouse gas reporting, national emission standards for hazardous air pollutants (NESHAP), waste, and water regulations, among others.
Although the tendency is to focus on regulatory requirements, a more productive strategy includes awareness of agency activities such as public policy discussions, rule development and interpretation, and enforcement. Since regulations are usually reactionary, they are often indicators of issues most important to stakeholders or are responses to real-life incidents that resulted in cause for public concern. Even if a proposed regulatory regime does not come to fruition, it can be beneficial for a company to identify the genesis of the proposal and determine if mitigation of the underlying cause should be considered. This puts the company in a good position to address issues on its own terms and be able to successfully meet challenges whether they are generated by regulations or other factors.
The Supply Chain
The supply chain is an essential component of successful integration of green chemistry into pharmaceutical processes and products. Active pharmaceutical ingredient (API) manufacturers can be an integral part of the pharmaceutical supply chain and need to be part of any green chemistry program or ISO 14001:2015 certification.
Environmental requirements driven upstream into the supply chain are not uncommon. Contracting companies have many tools to engage its supply chain and move their suppliers towards sustainability such as implementation of sustainability programs, development of sustainability indices, environmental management and compliance audits, and environmental performance expectations in contract language.
It is also possible that pharmaceutical companies may find suppliers adopting their own green chemistry programs and sustainability metrics. Contracting companies may support their suppliers’ efforts and work within their supply chain to maximize resources and cooperation to everyone’s advantage. This process may benefit from outside facilitation and good practice sharing to help participants focus on broader objectives supported by more tailored processes and procedures within.
A connected world means informed consumers. The advent of smartphones, tablets, and apps has made information mobile and more attainable. Knowledge of chemicals and their impacts on human health and the environment has become more extensive and accessible, widening the focus of concerned consumers from the product itself to how it is manufactured and where its ingredients are sourced.
Pharmaceutical companies should be prepared to respond to consumer inquiries about the supply chain of their products as they pertain to energy and climate, material efficiency, natural resources, and people and communities. This requires a full accounting of chemical ingredients and the impacts of the entire product manufacturing process on natural and human communities.
Activist investors are becoming more prevalent and influential. These investors are not averse to promoting agendas that drive sustainability, green chemistry, and transparency; nor to the publicity that such campaigns can engender.
According to the website GreenBiz, “Investors care about the chemical footprint of corporations.”[i] The reasons, as noted in the GreenBiz post, are straightforward: “Toxic chemicals in products and supply chains are hidden liabilities, posing potentially significant regulatory and reputational risks to brands. Investors increasingly have little patience for companies that ignore the science, policy and consumer concerns with hazardous chemicals.”[ii]
Even non-toxic and non-hazardous constituents can be problematic if their origins cause damage to ecosystems or vulnerable human populations. Ingredients and processes need a thorough lifecycle analysis to identify adverse impacts and ensure that mitigation does not merely shift an undesirable effect from one environment to another. Examples of this are palm oil, the widespread use of which resulted in deforestation and water pollution, and carnauba wax which has a complicated path to true sustainability – a path often not followed. Related concepts include avoiding “Regrettable Substitutions” and implementation of the “Precautionary Principle,” discussions of which are saved for another day.
Of the five golden rules outlined by GreenBiz, #3 Reduce your chemical footprint by substituting chemicals of high concern with safer alternatives, clearly is connected to green chemistry.
Non-Governmental Organizations (NGOs)
Non-governmental organizations (NGOs) have played a major role in advancing the need for sustainable development and green chemistry at the national and international levels. Campaigning groups have been key drivers of inter-governmental negotiations spanning a wide range of sustainability issues.[iii] They have done so as partners, influencers, and watch dogs. These organizations include environmental groups; consumer, women’s, and health groups; trade unions; and animal welfare and animal rights groups. Although the priorities of these organizations may differ, safer alternatives to the use of hazardous chemicals and toxic materials are the common theme.
As these groups consider chemical aspects and impacts of pharmaceuticals production, the industry should review and consider their own green chemistry and sustainability goals as they work to address the concerns of NGOs and their membership. Company programs should be based on the materiality to the company while acknowledging the concerns of outside stakeholders. At the same time, the pharmaceutical industry needs to acknowledge the value and necessity of NGO independence, even as they work together on policy development and initiatives. The overarching goal may be the same, but the path and milestones to get there can differ.
[i] GreenBiz, The Right Chemistry: 5 Golden Rules for Investors on Good Governance and Safer Chemicals, Lauren Compere, April 30, 2018
[iii] The Rise and Role of NGOs in Sustainable Development, International Institute for Sustainable Development (iisd) website