3.3 Product Legislation
41
consulted, as well as health-care professionals and patients. Once the CHMP has
decided to either authorize or reject the drug, the application is forwarded to
the European Commission, where the final, legally binding decision is made and
published. After authorization, the EMA’s Pharmacovigilance Risk Assessment
Committee and EU member states continue to monitor the medicine in terms of
its effectiveness, side effects, and other risks that might arise. Should they detect an
issue, the committee has the option to restrict the use or suspend the medicine to
protect patients (EMA, 2019a).
3.3.5 Key Legislation in the United States and Canada
In North America, both the United States and Canada have set up their own
legislation pertaining to chemical products. In the United States, the Environmental
Protection Agency (EPA) is mandated to enforce many of the regulations related to
the production and use of industrial chemicals. Signed into law in 2016, the Frank
R. Lautenberg Chemical Safety for the 21st Century Act (US EPA, 2018b) amends
and updates a much earlier chemical legislation known as the Toxic Substances
Control Act (TSCA), which had been in force since 1976. The EPA compiles and
maintains a list (inventory) of each chemical substance manufactured or processed
in the United States, also including imported substances (US EPA, 2018c). Any new
substances require advanced submission of a pre-manufacture notice (PMN) that is
then reviewed by the EPA to determine if risk management action is needed.
Evaluation of existing substances within the inventory is an ongoing process,
and the EPA has been tasked with prioritizing existing substances for evaluation.
Substances identified as high priority are then evaluated by the EPA, including
hazard and exposure assessments, to determine if the substances present an unreasonable risk to human health or the environment. Notably, the EPA is not allowed to
consider non-risk factors (including costs) when making their assessment decision.
If a substance is found to pose an unreasonable risk, the EPA must propose a rule
that manages the risk. Between its inception in 1976 and the year 2019, however, the
EPA had only banned or restricted a handful of chemicals or groups of chemicals
through TSCA and the Lautenberg Act (US EPA, 2019).
The management of industrial chemicals under Canadian law is based largely
on the Canadian Environmental Protection Act (CEPA), first introduced in 1988
and updated in 1999 (Government of Canada, 2018). Under CEPA, the government
is responsible for preventing or reducing risks concerning toxic substances. The
definition of substance here includes not only individual industrial compounds
but also any mixtures or complex mixtures including those formed naturally and
including biotechnology products, effluents, emissions, and wastes. Substances can
undergo a risk assessment and then risk management for identified risks to be
controlled. An assessment carried out under CEPA aims to determine specifically
whether or not a substance is toxic, which is a term defined broadly within the
regulation.
41
consulted, as well as health-care professionals and patients. Once the CHMP has
decided to either authorize or reject the drug, the application is forwarded to
the European Commission, where the final, legally binding decision is made and
published. After authorization, the EMA’s Pharmacovigilance Risk Assessment
Committee and EU member states continue to monitor the medicine in terms of
its effectiveness, side effects, and other risks that might arise. Should they detect an
issue, the committee has the option to restrict the use or suspend the medicine to
protect patients (EMA, 2019a).
3.3.5 Key Legislation in the United States and Canada
In North America, both the United States and Canada have set up their own
legislation pertaining to chemical products. In the United States, the Environmental
Protection Agency (EPA) is mandated to enforce many of the regulations related to
the production and use of industrial chemicals. Signed into law in 2016, the Frank
R. Lautenberg Chemical Safety for the 21st Century Act (US EPA, 2018b) amends
and updates a much earlier chemical legislation known as the Toxic Substances
Control Act (TSCA), which had been in force since 1976. The EPA compiles and
maintains a list (inventory) of each chemical substance manufactured or processed
in the United States, also including imported substances (US EPA, 2018c). Any new
substances require advanced submission of a pre-manufacture notice (PMN) that is
then reviewed by the EPA to determine if risk management action is needed.
Evaluation of existing substances within the inventory is an ongoing process,
and the EPA has been tasked with prioritizing existing substances for evaluation.
Substances identified as high priority are then evaluated by the EPA, including
hazard and exposure assessments, to determine if the substances present an unreasonable risk to human health or the environment. Notably, the EPA is not allowed to
consider non-risk factors (including costs) when making their assessment decision.
If a substance is found to pose an unreasonable risk, the EPA must propose a rule
that manages the risk. Between its inception in 1976 and the year 2019, however, the
EPA had only banned or restricted a handful of chemicals or groups of chemicals
through TSCA and the Lautenberg Act (US EPA, 2019).
The management of industrial chemicals under Canadian law is based largely
on the Canadian Environmental Protection Act (CEPA), first introduced in 1988
and updated in 1999 (Government of Canada, 2018). Under CEPA, the government
is responsible for preventing or reducing risks concerning toxic substances. The
definition of substance here includes not only individual industrial compounds
but also any mixtures or complex mixtures including those formed naturally and
including biotechnology products, effluents, emissions, and wastes. Substances can
undergo a risk assessment and then risk management for identified risks to be
controlled. An assessment carried out under CEPA aims to determine specifically
whether or not a substance is toxic, which is a term defined broadly within the
regulation.