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Media and Political Bulletin – 29 May 2020

Media and Political Bulletin

29 May 2020

Coronavirus (COVID-19): travellers exempt from UK border rules

UK Home Office, 22 May 2020

Last Friday Home Secretary Priti Patel announced new public health measures for all UK arrivals to guard against a second wave of coronavirus infections. Measures include 14 days’ self-isolation for anyone entering the UK, bar a short list of exemptions. Of particular importance to our sector, the below exemptions have been granted:

  • Qualified persons and responsible persons for human medicines, clinical trials and pharmacovigilance.
  • A worker with specialist technical skills, where those specialist technical skills are required for essential or emergency works or services (including commissioning, maintenance, and repairs and safety checks) to ensure the continued production, supply, movement, manufacture, storage or preservation of goods.

These arrangements are due to come into effect on 8 June, and measures will be subject to review every three weeks.

Media Summary

Community pharmacies to receive an additional £50m loan to mitigate COVID-19 pressures

The Pharmaceutical Journal, Julia Robinson, 28 May 2020

The Pharmaceutical Journal reports that community pharmacies will receive a further £50m of advance funding from the government to help with cash flow pressures during the COVID-19 pandemic, the Pharmaceutical Services Negotiating Committee (PSNC) has announced.

The payment follows the £300m in advance funding already paid to contractors this year in recognition of COVID-19 related cash flow challenges.

The NHS Business Services Authority (NHSBSA) clarified that, similar to the £300m uplift, the £50m was “not additional funding over and above what was agreed for 2020/2021 under the Community Pharmacy Contractual Framework five-year deal” and would be reconciled in 2020/2021.

It added that the mechanism and time period over which the reconciliation would take place had not yet been agreed by the PSNC.

This was also reported in Pharmacy Business, P3 Pharmacy and Chemist + Druggist.

EMA explains GMP and GDP flexibilities amid COVID-19

Regulatory Focus, Michael Mezher, 28 May 2020

Regulatory Focus reports that the European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).

The new flexibilities are meant “to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic and ensure availability of medicinal products to respond to increased demand,” the guidance states.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Community pharmacies to receive an additional £50m loan to mitigate COVID-19 pressures

The Pharmaceutical Journal, Julia Robinson, 28 May 2020

The Pharmaceutical Services Negotiating Committee has announced that community pharmacies will receive an additional £50m in funding on 1 June 2020, but the money will eventually have to be repaid.

Community pharmacies will receive a further £50m of advance funding from the government to help with cash flow pressures during the COVID-19 pandemic, the Pharmaceutical Services Negotiating Committee (PSNC) has announced.

In a statement published on 28 May 2020, the PSNC said that the NHS Business Services Authority (NHSBSA) was calculating payments with the intention of paying the £50m loan at the same time as the contractors’ payment on 1 June 2020.

The payment follows the £300m in advance funding already paid to contractors this year in recognition of COVID-19 related cash flow challenges.

The NHSBSA clarified that, similar to the £300m uplift, the £50m was “not additional funding over and above what was agreed for 2020/2021 under the Community Pharmacy Contractual Framework five-year deal” and would be reconciled in 2020/2021.

It added that the mechanism and time period over which the reconciliation would take place had not yet been agreed by the PSNC.

In its announcement, the PSNC said that it was “continuing to highlight to the NHS and HM Government the urgent need for extra funding for the sector”, which included seeking to prevent contractors having to repay any of the advance payments that they have so far received this year.

The PSNC reiterated that its bid for extra funding was “currently being considered by HM Treasury”.

Simon Dukes, chief executive of the PSNC, said the latest £50m advanced payment “should help to ease some of the immediate cash flow and procurement pressures on businesses”.

“We do not know how this pandemic will develop and the long-term effects it will have on pharmacy, but we will continue to gather evidence of contractors’ costs and other financial pressures and to press for margin adjustments and further financial assistance wherever we have a case to do so.”

Dukes previously warned on 16 March 2020 that pharmacies are on “the brink of collapse” owing to the financial strain of the COVID-19 pandemic, with pharmacy bodies calling for an extra £200m to stay afloat.

Mark Lyonette, chief executive of the National Pharmacy Association, said the additional advanced funding “makes talks on cost recovery even more urgent”.

“We need assurances on the medium-term position, because this new advance effectively increases the level of pharmacies’ debt to government,” he said. “Many independent pharmacies will struggle to pay it back and should never be asked to do so.”

Claire Anderson, chair of the Royal Pharmaceutical Society English pharmacy board said that while the funding may help pharmacies to stay open it was “another stop-gap measure” and should be coming from new money, rather than an advance payment.

“The government should review this as part of a fair funding settlement for the longer-term,” she said.

“The ‘new normal’ for the NHS coping with COVID-19 will need a contract which makes the most of pharmacists’ clinical skills to support patients, improve medicines safety, and help people stay healthy and out of hospital.”

The NHSBSA said that pharmacy contractors should be aware that the uplift would not show on their schedule of payment, but that it would be sending a letter to each contractor outlining the additional payment.

This was also reported in Pharmacy Business, P3 Pharmacy and Chemist + Druggist.

EMA explains GMP and GDP flexibilities amid COVID-19

Regulatory Focus, Michael Mezher, 28 May 2020

The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).

Specifically, the guidance lays out four questions and answers pertaining to GMP flexibilities and three questions and answers on GDP flexibilities, as well as a new section on the suspension of on-site inspections of plasma collection centers.

The new flexibilities are meant “to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic and ensure availability of medicinal products to respond to increased demand,” the guidance states.

The guidance also encourages member states to implement the new provisions “in order to minimize the disruption of manufacturing and supply of crucial medicines in [the European Economic Area].”

GMP flexibilities

According to the guidance, it is possible for companies to rely on limited prospective qualification to introduce new premises and/or equipment to ensure the continuous availability of medicines needed to treat COVID-19.

To do so, the guidance says that companies must use quality risk management principles to “determine the required scope and extent of the limited prospective qualification” and that additional risk mitigation measures should be adopted. Any decisions should be documented within the pharmaceutical quality system (PQS) and be cleared by the authorized personnel. Regular qualification must be resumed “as soon as COVID-19 restrictions are lifted.”

The guidance also allows for concurrent validation of manufacturing processes. “For crucial medicines for treatment of COVID_19 patients and where delay in supply may affect those treatments, it is acceptable to conduct process validation concurrently rather than prospectively,” the guidance states.

“Where a concurrent process validation approach is employed, there should be sufficient data to support a conclusion that any given batch of product is uniform and meets the defined acceptance criteria,” the guidance states, noting that processes that assure sterility for sterile products must continue to be prospectively validated.

Companies are also permitted to make temporary changes to certain quality related tasks, “provided that the changes do not adversely impact quality, efficacy and safety of medicinal products manufactured [at] the site.”

This includes deferring certain routine tasks such as maintenance, requalification, revalidation, recalibration, periodic review of PQS documents, on-site re-audits of suppliers, periodic re-trainings and “deferral of stability testing, where justified, to focus resources on product release testing.”

The guidance also provides flexibilities to speed access to imported medicines used to treat patients with COVID-19 to address imminent shortages, including postponing or waiving testing in the third country and postponing certain testing in the EEA.

GDP flexibilities

The guidance also explains temporary flexibilities for GDP during the pandemic related to the duties of the responsible person (RP), the use of new equipment or newly authorized premises for storage and distribution and deviations from normal practice.

According to the guidance, RPs may work remotely during the pandemic only if the “regional or national government authority has implemented quarantine measures such as stay-at-home restrictions for entire regions or the whole country resulting in cancellation or prohibition of travelling.”

The guidance also allows for the potential for RP duties to be delegated under limited circumstances.

Additionally, the guidance explains that “new equipment or re-purposed equipment may be used with limited prospective qualification to allow it to be used as soon as possible” to distribute medicines.

“Where prospective validation has been limited for premises and equipment used for the storage and distribution of medicines then this should be compensated by employing sufficient ongoing monitoring such that there is evidence that medicines are stored and transported under the required conditions,” the guidance states.

Lastly, the guidance permits certain deviations from normal practice during the pandemic, including changes related to documentation, audits, non-conformity and corrective and preventative action (CAPA) management and training.

Media and Political Bulletin – 29 May 2020

From Factory to Pharmacy

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