May 17, 2020

3 Mining Companies Leading the Fight Against HIV/AIDS (and Other Diseases)

HIV
HIV
Admin
2 min
As well as having potentially devastating human and community costs, the cost of HIV/AIDS, tuberculosis and malaria can be significant for a mining and metals company.
There are 35 million people in the world currently living with HIV/AIDS, with the vast majority of said individuals living in low- and middle-income cou...

There are 35 million people in the world currently living with HIV/AIDS, with the vast majority of said individuals living in low- and middle-income countries, according to AIDS.gov.

While the mining industry doesn’t necessarily come to mind when thinking of HIV/AIDS awareness and prevention, many of the world’s largest mining companies are engaged in individual initiatives and partnerships designed to combat HIV/AIDS, from providing for employee testing to funding cutting-edge research.

The following three mining organizations are contributing to the fight against HIV/AIDS, as well as a slew of other diseases.

1. Anglo American – HIV/AIDS and TB

Committed to the safety and health of every employee, Anglo American is a global and diversified mining business that provides the raw materials essential for economic development and modern life.

[READ MORE] TOP 10: Research Companies on the Forefront of HIV/AIDS Eradication

Anglo American runs one of the largest corporate schemes for HIV/AIDS, which includes testing, treatment, education and counseling for employees.

In addition, the mining giant is also tackling tuberculosis (TB), which has become epidemic in South Africa. TB and HIV often go hand in hand, which is why Anglo American tries to test and treat for both diseases as early as possible.

In 2013, Anglo American tested and counseled approximately 93,000 employees and contractors in southern Africa.

2. International Council on Mining and Metals (ICMM) – HIV/AIDS, TB and Malaria

As a leader in the mining industry, ICMM is engaged in a variety of individual initiatives and partnerships designed to combat HIV/AIDS. The organization has set up free testing for employees, implemented community peer educator programs and provided workplace and family treatment plans to funding cutting-edge research for the disease.

In their published manual Good Practice Guidance on HIV/AIDS, TB and Malaria, they state, “A direct link exists between a mine’s employees/contractors and the outside community due to, for example, shared living arrangements, social intercourse and the movement of malaria mosquito vectors across boundaries. In order to effectively manage these diseases, a partnership with communities and other organizations with similar goals is necessary and will significantly increase the scale and impact of any management program.”

[READ MORE] 3 Ways to Accelerate Progress in the Fight Against HIV/AIDS

3. Barrick Gold – HIV/AIDS

Since 2008, Barrick Gold has organized and implemented a series of public awareness activities designed to de-stigmatize HIV/AIDS and promote voluntary testing in the countries they operate.

The company has mining operations and projects in a number of high risk countries, including Tanzania, Papua New Guinea and South Africa and is committed to minimizing the negative social, economic and human rights impacts of HIV/AIDS on its employees. 

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.

The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.

The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.

The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline. 

This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:

Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking. 

Rigorous Planning
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.

Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.

Authorised Representatives
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.

For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established. 

Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users. 

While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.

Clinical Investigations
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.

Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.

Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.

As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.

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