Environmental sustainability should be built into GMP; MPA

27-Jan-2010 - Last updated on 03-Feb-2010 at 13:18 GMT

Environmental certification of production facilities should be introduced to GMP legislation and sustainability risk assessments linked to marketing authorisations, according to a MPA report.

Swedish research indicated that emissions from the manufacture of drugs and active pharmaceutical ingredients (API) in India could seriously affect human and animal health.

This led to the Swedish government commissioning its Medical Products Agency (MPA) to investigate how to strengthen environmental requirements. The MPA has now published its findings in a report.

As a first priority the MPA proposes that good manufacturing practice (GMP) legislation is expanded to include a requirement for the environmental certification of drug and API production facilities.

Changes to national legislation would have limited impact, according to the MPA, and consequently the agency is pushing for a harmonised policy to cover the European Union (EU).

“The European Commission (EC) needs to set the agenda”, Charlotte Unger, scientific director, environment at MPA, told in-PharmaTechnologist. To drive this forward the MPA has been in discussions with the relevant people in the EU.

Enforcing the revised legislation would require resources but Unger believes the potential for long-term harm means “it will be more expensive to ignore” the issue. These costs could ultimately be felt by governments and pharma companies.

The MPA also proposes that an environmental risk assessment is included in the application for the marketing approval of a drug. This would give the EU the power to deny a marketing approval based on the risk of negative environmental effects.

Voluntary action

Production in India is a big concern for the MPA and a delegation is travelling to the country this weekend. Sweden and India have a bilateral agreement covering health which is being expanded to include pharmaceuticals. Environmental impact of drug manufacture is on the agenda.

Given the level of outsourcing to India, and other emerging markets, the environmental policy can also be influenced by Western companies. Consequently, the MPA views controlling emissions from subcontractors as the most significant voluntary action.

Unger acknowledged that this can be difficult, especially given the number of stakeholders involved, but believes that pharma companies could be doing more to limit their environmental impact.

Some pharma firms have made positive progress, according to Unger, but overall the industry lags behind other sectors. Unger cited IKEA and H&M as businesses which have been proactive and developed more advanced environmental policies than the pharma industry.

Pharma can learn from these companies and there is also the possibility of shared guidelines or legislation. Unger believes this is possible because many industries have the common problem of minimising the environmental impact of chemical waste.