Legislation to ensure sustainability of national medicines policies
Symposium 1
Convenor
Rapporteurs
Michele Forzley, USA
David Newby, Australia
Jane Robertson, Australia
Summary of key issues
Law is hierarchical. International law and national legislation are important, but administrative regulations, codes and standards are useful instruments to manage the pharmaceutical sector.
Wording of the law is important. There is a need to mandate what governments are obliged to do.
Political will is needed to enforce the rule of law.
High profile legal action can serve as an effective deterrent to infringements of medicine-related law.
There is a need to address the mismatch between breaches and penalties. Penalties are needed to deter others.
Drug regulatory authority inspectors need adequate powers as well as training and support to successfully implement laws and regulations related to medicines.
Key barriers
Lack of political will to maintain the expertise and adequate numbers of qualified staff.
Limited data on how laws are implemented, their effects and impact, and how the law is broken.
Corruption in some sectors has the potential to undermine regulatory and enforcement efforts.
Key enablers
Respect for the rule of law. A comprehensive body of law should support drug regulatory agency functions. There should be effective enforcement of laws and regulations.
Training and support for medicines inspectors to gather the evidence required to facilitate prosecution in the courts.
Steps to address barriers and enablers
Better dissemination and sharing of best practice regulations, codes and standards. This may be facilitated by sharing digitised versions of laws and regulations.
Greater collaboration between the legal and health sectors regarding medicines law.
Consider development of a regional taskforce to review national laws relating to access to medicines.
Provide a forum to learn about sanctions that have been successful in the pharmaceutical sector.
How to monitor progress in implementation
There should be routine monitoring and reporting on the staffing and functions of drug regulatory agencies, and the outcomes of regulatory activities including inspections.
Patients in pain require effective analgesia, however outcomes with opioid medicines depend on how they are used by consumers and health professionals within health systems.
There are cultural differences in attitudes to pain and its treatment.
Some countries have low, sometimes suboptimal, use of opioids, while others have very high use, especially in chronic non-cancer pain.
There is a lack of evidence for the effectiveness of opioids in some forms of chronic pain. Rising opioid use is associated with increased harm including death, but inadequate treatment of pain is also harmful.
Legal requirements for prescribing opioids vary widely between countries.
There is a lack of policy and guidelines on prescribing opioids in some countries, especially for chronic non-cancer pain.
Key barriers
Some health professionals are unduly fearful of prescribing opioids.
Lack of access to opioids or effective alternatives. This may be due to narcotic laws limiting availability. In other cases supply chain issues affect availability.
Key enablers
Development and dissemination of evidence-based treatment guidelines and education of health professionals regarding the rational and safe use of opioids.
Access to effective adjunctive or alternative treatments for pain, including non-pharmacological options.
Policies, standards and regulations to enable access, supply and appropriate use of opioids.
Steps to address barriers and enablers
Access to evidence-based treatment guidelines and health professional training in opioid use.
Further research to provide evidence to support the use of opioids for pain in different settings.
How to monitor progress in implementation
There should be regular monitoring and reporting of opioid procurement, access and use within country.
National initiatives involving opioids need to link with international surveillance activities carried out by the International Narcotics Control Board.
Medicines-related data are powerful and should be relevant to need. There should be local level ownership and understanding of data. Start with simple efficient systems and build on successes.
Collecting and managing data requires a skill base. There is a need for capacity building for data collection, analysis, interpretation and presentation of results in formats suitable for feedback to decision makers and other stakeholders.
Medicines monitoring can be used to improve drug selection and procurement, measure availability and affordability, and (with increasing sophistication of data sources and information technology) link to health outcomes of therapy.
Efficient and effective methods for monitoring are required with clear and concise formats, agreed frequency of reporting, timeliness for decision making, and feedback to stakeholders to facilitate the quality use of medicines.
Key barriers
Limited political and financial commitment to monitoring and a lack of awareness of its value. There are few incentives to collect medicines-related data.
Limited workforce to undertake monitoring, data analysis and interpretation, and limited budgets for training.
Validity, relevance and usefulness of the data – timeliness of data provision and analysis, lack of understanding of data limitations including the representativeness of reports.
Key enablers
Governments and other stakeholders need to ‘own’ the processes of medicines monitoring, with clearly defined roles, responsibilities and reporting cycles.
Improved data quality with validated indicators is needed to assess medicines affordability, availability and rational use. Reports and presentations of key messages should be in simple formats for dissemination to all stakeholders.
Steps to address barriers and enablers
Establish appropriate reporting cycles for health sectors based on available resources.
How to monitor progress in implementation
Regular, routine use of medicines monitoring data derived from standardised methods is needed to inform key stakeholders for clinical practice, research, and to drive policy change.
There needs to be regional sharing of medicines monitoring information based on minimum data sets.
Patients are dependent on others (family, community, professionals, media) for getting correct diagnosis and unbiased information.
Health care should empower consumers to become health literate and move beyond the paternalistic approach which has characterised consumer–health professional interactions in the past.
Self-help can work – consumers can learn to understand medicine labels and other basic concepts of over-the-counter medicines, in group sessions with responsible media or peer-educators.
The poor and older people are at special risk, but are more difficult to reach with interventions and programs to develop health literacy.
Social media and the internet are powerful channels of health and medicines information and are widely accessible. They can be helpful, but also risky because much of the information is not independently scrutinised for accuracy and relevance.
Key barriers
Abundance of biased health and medicines information and promotion, and relative lack of objective, understandable information on medicines and their appropriate use.
Vested interests and system inertia have limited progress to date.
Key enablers
Community-based organisations promoting appropriate use of medicines and empowered, health literate consumers asking ‘WHY?’, and actively seeking information on medicines.
Access to unbiased information on medicines and health. Understanding needs more than just good information – messages must be clear, simple, objective and motivate for appropriate action.
Steps to address barriers and enablers
Government valuing health literacy as a national priority that provides long-term health benefits for the nation.
Consumer education programs to improve health literacy – health education begins in schools.
Community organisations and peer networks can support appropriate use of medicines.
How to monitor progress in implementation
Develop and evaluate tools to measure steps towards health literacy.
Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. NPS MedicineWise disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. Read our full disclaimer. This website uses cookies. Read our privacy policy.
