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A B C D E F G H I J K L M N O P R S T V W Y

Pharmacy and the Law

A selection of articles for the pharmacy sector written by Richard Hough, a Partner and pharmacist in the commercial team, which are printed in pharmacy sector publications.

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Going against the grain

Wednesday 18th October 2017

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Richard Hough, Pharmacy Lawyer suggests that, counter-intuitively, the pharmacy cuts could actually lead to business expansion.

The negative impact on balance sheets nearly a year after the government imposed significant funding cuts on community pharmacy has seen a number of our clients approaching us with a view to exploring ways of mitigating the effect of the cuts. 

Of course, there are many reactive ways of mitigating the effect of reduced funding to maintain profitability, often negative in nature and which mainly involve either the most drastic option of deciding to cut their losses and sell up or the rather less drastic option of staying put and implementing cost-cutting measures. 

However, not all actions need to involve cutting overheads yet further. Perhaps counter-intuitively in response to the funding cuts, we continue to see a trend of smaller independent pharmacies approaching us with a view assisting them with their expansion plans. The three most common options explored are: 
• Formation of a corporate joint venture 
• Entering into a contractual joint venture 
• Mergers 

Corporate joint ventures 
The formation of a new corporate vehicle (most commonly, a limited company or a limited liability partnership) allows two or more existing pharmacies to work together and collaborate by sharing costs, resources and facilities. The corporate joint venture entity is often adopted in order to perform a particular function or undertake a project or for a limited length of time in order to ring fence liability accordingly. For instance, the formation of a new corporate vehicle could allow the new legal entity to bid for enhanced and locally commissioned service contracts while ensuring that the primary pharmacy operating businesses, which will be shareholders in the joint venture entity, remain largely protected. 

On a practical level, a new corporate vehicle poses considerable governance issues, which the parties must work through. Generally, each of the parties will have contributed assets to the corporate vehicle and in return will require due influence upon the ongoing management of the venture. This is not always easy. 

Contractual joint ventures 
This option does not require the creation of a new legal entity, as with the corporate joint venture. The parties remain independent pharmacy contractors, which have agreed to collaborate with each other by entering into a legally binding contract pursuant to which each entity is contractually obliged to perform certain services for one or more of the other parties. Such obligations may include sharing premises and staff, which allows the parties to streamline administrative functions such as payroll and back office support. The contract would include how financial liabilities would be shared and how decisions would be taken. Under such contractual joint venture arrangements, again it may be possible for one or more of the contracting pharmacies to bid, as lead entity, on behalf of the other parties for locally commissioned services. 

While a direct contractual arrangement avoids the parties having to negotiate the complex areas of governance necessary to successfully operate a corporate joint venture, it may in some cases prove to be a less secure arrangement between the parties. In particular, the primary pharmacy operating businesses are not ring fenced from liabilities incurred under the contract, which will be borne by the relevant primary business, in its capacity as one of the parties to the contract. 

From a commissioning perspective, both of the first two methods of collaboration allow those pharmacies involved to cover a wider geographical scope and potentially achieve economies of scale, which can be passed onto the commissioner. In a market where funds are limited and margins are tight, this is a very attractive proposition for commissioners. From an administrative perspective, each of the joint venture models allows commissioners to contract with one provider to cover a range of services. 

Mergers 
The final option is for one or more pharmacy businesses to merge with each other in order to create a larger organisation. New legislation came into effect in December 2016 that affords protection to two pharmacies that choose to consolidate into a single existing site where such consolidation does not create a gap in service provision. A merger involves all trading activities, assets, liabilities and capital of the two existing entities being held together with the merged entity serving the same joint customer base. 

The cost reductions involved in streamlining the business can make this an attractive option. The pharmacies will inevitably need less staff and, as such, be able to reduce their wage bills. In addition, there will be more scope to make operational and dispensary efficiencies through automation, streamlined supply chains and perhaps having access to huband- spoke dispensing. 

Despite the potential operational advantages, a merger involves sacrifice. Each party will almost certainly have less autonomy and be required to sacrifice its previous control and flexibility. Governance of the merged entity can prove more complex and sometimes contentious. 

We are certainly seeing a growing trend in pharmacies choosing to collaborate in one form or another. There are many pros and cons to be carefully considered when deciding which is the best option for each pharmacy. Circumstances will dictate which is the most appropriate. It is important to take advice from both solicitors and accountants and reach a decision that is bespoke to the pharmacy in question.

Richard Hough is partner, pharmacist, and head of healthcare at Brabners LLP. Contact him on 0151 600 3302, or at richard.hough@brabners.com.


Is there a doctor in the house?

Tuesday 17th October 2017

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Richard Hough, Pharmacy Lawyer examines the potential pitfalls of collaborative working practices

The General Pharmaceutical Council (GPhC) recently published a joint statement alongside eight other health and care professional regulators to give new guidance on “avoiding, declaring and managing conflicts of interest”. This statement comes at a prudent time, with NHS England stating in April last year that it would boost funding by £112m to facilitate collaborative working practices including the employment of a projected extra 1,500 pharmacists in GP practices by 2020. Indeed, the move to the adoption of more collaborative working between the healthcare professions has been welcomed by many, with benefits of increased efficiency and an easing of pressure on GPs. However, this “increasing move towards multi-disciplinary teams” is not without its pitfalls.

Joint ventures
Historically, pharmacies have operated independently from influence by GPs, with patients free to choose where their prescription is dispensed based on proximity and service. Recently, however, we have advised a number of pharmacists who have sought to protect (a defensive move) and/ or grow (an aggressive move) their business by forming joint venture-type arrangements with GP practices. Such arrangements can easily lead to conflicts of interest and unlawful behaviour.

For example, a GP may choose to recommend to a patient a pharmacy in which it has a financial interest, on the basis that the GP would directly benefit from the pharmacy’s increased business. The conflicts of interest can range from something as seemingly innocent as a misjudged suggestion from a GP’s receptionist, to the more serious matter of GPs lying to patients about their options. Both of these examples represent placing financial or personal gain above patient care – a clear conflict of interest for the doctor.

Previous guidance was limited to the General Medical Council’s advice on ‘financial and commercial arrangements and conflicts of interest’, which encouraged honesty and instructed doctors to tell patients about any financial or commercial interest they might have when referring a patient. This guidance does little to help pharmacists, particularly those working for doctors in a GP practice.

Clarifications
The recent GPhC’s joint statement attempts to gives clarification to pharmacists and other healthcare professionals on what does, or does not, constitute a conflict of interest and includes the following expectations:
• Put the interests of people in their care before their own interests, or those of any colleague, business, organisation, close family member or friend.
• Maintain appropriate personal and professional boundaries with the people they provide care to and with others.
• Consider carefully where conflicts of interest may arise – or be perceived to arise – and seek advice if they are unsure how to handle this.
• Be open about any conflict of interest they face, declaring it formally when appropriate and as early as possible, in line with the policies of their employer or the organisation contracting their services.
• Ensure their professional judgement is not compromised by personal, financial or commercial interests, incentives, targets or similar measures.
• Refuse all but the most trivial gifts, favours or hospitality if accepting them could be interpreted as an attempt to gain preferential treatment or would contravene your professional code of practice.
• Where appropriate, ensure that patients have access to visible and easy-to-understand information on any fees and charging policies for which you are responsible.

The joint statement also includes the following case study on prescription direction to accompany the guidance: Dr Williams is a GP in a private practice whose employer owns a local pharmacy. She has been instructed to encourage patients to take their prescriptions there as they will get “better service and faster processing times”. Dr Williams realises that she must always put the interests of her patients before her own or her employer’s interests, and that it would be inappropriate to make recommendations. She knows that directing prescriptions to her employer’s pharmacy would be likely to constitute a conflict of interest. The responsible course of action taken by Dr Williams is to make sure her patients know and understand that they can choose where to get their prescription. When advice is sought, she would continue to give a range of options and, if any patients asked her about that particular pharmacy, she would be open and honest about her employer’s interest in it.

Those pharmacy businesses which have GP involvement should ensure that staff are aware of and abide by such guidance on conflicts of interest, as competing businesses will be keen to ensure that professional standards and regulatory requirements are not breached. Gifts, for example, should not be offered to any staff within the GP practice, no matter how trivial. Personal boundaries between colleagues should be maintained and relationships should be professional at all times. It is important to remember that professional judgement may also be compromised by personal interest, in addition to financial or commercial.

The joint statement represents a shift in regulatory focus towards highlighting the potential dangers of adopting collaborative working practices and engaging joint ventures between pharmacies and GP practices. The GPhC’s statement makes it clear that in cases of conflict the best course of action is to be honest and when in doubt, we would always recommend seeking expert legal advice.

Richard Hough is partner, pharmacist, and head of healthcare at Brabners LLP. Contact him on 0151 600 3302 or email richard.hough@brabners.com


Are you malware aware?

Tuesday 17th October 2017

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Richard Hough, Pharmacy Solicitor advises on the best digital defence when it comes to patient data protection

The cyber attack on the NHS computer system earlier this year, in which hackers spread ransomware called WannaCry, created havoc for healthcare professionals and patients alike. Hospitals and GP surgeries were among numerous health service organisations hit by the ransomware attack. It also affected an estimated 200,000 computer systems of other organisations in 150 countries around the world.

Those hospitals and doctors’ surgeries whose computer systems were affected were forced to turn patients away, putting yet further strain on pharmacy resources. The ransomware, which scrambled data on computers and locked out users, demanded payments of between $300 to $600 in order to restore access. It was only due to the actions of Marcus Hutchins, a 22-yearold self-taught programmer from Devon, that the ransomware attack was prevented from creating further havoc by triggering a “kill switch”.

Gone phishing
So what is ransomware and what is its relevance to an increasingly digitally-reliant pharmacy profession? Ransomware is a type of computer virus (often called malware) that is frequently delivered via emails, which trick the recipient into opening attachments and releasing the malware onto their computer system in a technique known as phishing. Once the recipient’s computer has been infected, it locks up the files and encrypts them in a way that prevents access to them. It then demands payment in order to regain access. Because malware is spread by faceless criminals, there is no guarantee that, even after payment, access to your files will be restored.

So how did WannaCry wreak its havoc? It did so by exploiting a vulnerability in the operating system Microsoft Windows for which Microsoft released a patch to fix the vulnerability in March. However, not every computer user is diligent in installing regular updates and patches on their computers when prompted to do so, which means that the system can remain needlessly vulnerable to a potential malware attack. Such complacency plays right into the hands of hackers, allowing them access to the computer system to spread their chaos.

It is possible to remove malware from a computer with advanced anti-virus software or by putting the computer into safe mode and manually removing the infected files. However, as anyone who has previously suffered a catastrophic computer meltdown at the hands of a virus or other malware will testify, with computers, as in healthcare, prevention is often better than cure.

Cyber security measures
In light of this recent malware attack, it may be worth revisiting a report published earlier this year by the Information Commissioner’s Office (ICO), which among other things oversees the protection of personal data and the promotion of cyber security. This report related to its findings from its work relating to community pharmacies. It sought to promote good data protection practices and guidance for the community pharmacy sector.

The report noted encouragingly that, while there was a wide variation across individual pharmacy organisations, “generally staff and organisations have a good awareness of the requirement to keep personal data safe and confidential and are motivated to do so”.

The study sets out the areas where community pharmacies are doing well, as well as highlighting the common problems and areas for improvement, and includes further guidance and advice to help community pharmacies improve their information governance and data protection practices.

With the expansion of services being offered within community pharmacy, and the recognition that pharmacies and their staff process a “significant amount of highly sensitive personal data”, getting data protection practices right is of paramount importance. Failure to do so can lead to serious consequences, ranging from an ICO investigation and heavy fines to reputational damage and serious loss of business.

One of the main observations was that it was “rare for an organisation to be consistently successful” in all the areas of data processing. Ongoing training was identified as one of the hardest to achieve successfully in smaller businesses where resources may be more limited, but was highlighted as a key area of focus to ensure staff maintain good cyber security and data protection practice.

Be prepared
The report made a number of recommendations for improvement, which if implemented will ensure good data protection practice within pharmacy businesses and minimise the risk of them suffering a cyber attack: • Ensure that all computers that process sensitive personal data, and are connected to a network, are upgraded to a supported operating system.
• Ensure no networked computers are unprotected from cyber attacks or malware.
• Implement a mechanism for “safe haven” procedures to maximise the secure use of fax machines where there are no other alternatives and their use remains necessary.
• Rollout the use of individual user logons for all systems that contain patient identifiable data to enable a full audit trail of view and change events to a patient’s record.
• NHS Smart Cards should only be used by the registered holder.
• Policies and procedures need to be in place to:
o control the removal of personal data from the pharmacy
o monitor staff for compliance with standards
o identify which records are to be retained and destroyed securely o ensure compliance with marketing consent legislation and the relevant record keeping required.

Richard Hough is partner, pharmacist, and head of healthcare at Brabners LLP. Contact him on 0151 600 3302 or email richard.hough@brabners.com


Parallel worlds

Monday 22nd May 2017

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Independent Community Pharmacist magazine article - May 2017

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

The United Kingdom’s vote to leave the EU last June and Theresa May’s recent decision to trigger Article 50 will, to put it mildly, create one or two legal issues for the UK, or to put it more accurately, will create the mother of all legal messes.

Good news, at least, for the lawyers, you might say. However, one such legal issue, which pharmacy proprietors might need to consider, is the potential impact that Brexit will have on the parallel import of pharmaceutical products.

The dispensary shelves of community pharmacies up and down the country contain numerous parallel import products. The business of buying and selling parallel imports, insofar as it relates to community pharmacy, encompasses the trading of genuine pharmaceutical products at the different prices that can be obtained in the different Member States of the EU.

A manufacturer of a particular pharmaceutical product will be prepared, for economic, commercial, business or other considerations, to put its product on the market of one Member State at a materially lower price than it is prepared to do so in another. The price differential, together with the fundamental principle of free movement of goods within EU Member States, creates a demand from purchasers within territories where the prices are set high, which can be met by sellers located in territories where prices are set low.

Trade mark law

European trade mark law is central to the business of parallel imports. Parallel imported products of the type that are commonly found in community pharmacy dispensaries are all protected in some way or another by trade mark rights.

Trade mark rights are territorial in nature, affording the trade mark owner the exclusive right to commercially exploit its products under that brand within a particular territory. So, if another trader attempts to commercially exploit a trade mark owner’s product (using it in the course of business) by trading it under the owner’s brand, it would, but for the doctrine of “exhaustion”, as provided for in Article 13.1 of the European Trademark Regulation, be in breach of the trade mark owner’s rights. Article 13.1 states: “A Community trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent.”

Therefore, once a product labelled with a trade mark has been sold by the trade mark owner or with its consent, the trade mark right is said to be “exhausted” and can no longer be enforced by the owner.

However, the effect of exhaustion of trade mark rights is limited to such goods that were first distributed to the market within the EU and also Iceland, Liechtenstein and Norway, together the EEA. Therefore, any imported pharmaceutical product from outside the EEA, which is put on the market within the EEA without the consent of the trade mark owning pharmaceutical company immediately constitutes trade mark infringement.

So, the future availability of parallel imports of pharmaceutical products will depend on the post-Brexit trade model with the EU adopted by the UK, the three main contenders being:

  • “Norwegian model”. Norway has full access to the European Single Market. In return, it is obliged to make a financial contribution and accept a whole range of EU regulations. If the UK adopts a similar model, it will stay closely connected to the EU with the advantage of full accessibility to the European Single Market. Choosing the “Norwegian model” would imply that the doctrine of exhaustion would continue to apply to the distribution of parallel imports in the UK.
     
  • “Swiss model”. Switzerland’s relationship with the EU is governed by numerous bilateral treaties, under which Switzerland has achieved broad access to the European Single Market and is able to trade in most goods. In the event that the UK re-joins the European Free Trade Association (EFTA), it would still have partial access to some elements of the Single Market but also have the freedom to independently reposition its own free trade policy to focus on non-EU countries. Therefore, in order to allow parallel imports from the UK, it would also have to negotiate separate bilateral agreements with the EU on the treatment of trade mark rights, including the scope of the exhaustion of such rights for cross-border trades.
     
  • “Hard Brexit”. The current Tory government favours a “hard” Brexit – leaving the Single Market and trading with the EU as if the UK were any other non-EU country. If the UK leaves the EU without joining (or re-joining) associations such as EFTA, the doctrine of exhaustion will cease to apply, as would therefore the legal basis for both parallel imports into and out of the UK. Brexit negotiations will no doubt begin in earnest after the outcome of next month’s general election, pursuant to which, depending on which model we end up adopting, legal parallel imports may no longer be found on UK pharmacies’ dispensary shelves and further impacting contractors’ profit margins.

For more information please contact: 



Richard Hough
Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com

 


Bullying in the workplace

Tuesday 31st January 2017

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Independent Community Pharmacist magazine article - January 2017

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

According to a 2015 report by the Advisory, Conciliation and Arbitration Service (ACAS), workplace bullying is on the rise, with about 20,000 calls relating to bullying being made each year to ACAS alone. Regrettably, bullying of staff members by pharmacy owners, managers, supervisors and work colleagues also occurs in community pharmacies.

Pharmacy owners should not underestimate the impact that workplace bullying can have on their businesses. Bullying and harassment can, if left unchecked or badly handled, create serious problems for the pharmacy, including poor morale and poor employee relations, loss of respect for managers and supervisors, poor performance, absence, and damage to the business’s reputation.

In addition, pharmacy owners should be aware that workplace bullying can result in an employment tribunal claim or court cases, and payment of unlimited compensation to victims. It is therefore in your interests to promote a safe, healthy and fair environment in which your staff can work.

Bullying defined

Bullying may be characterised as offensive, intimidating, malicious or insulting behaviour, an abuse or misuse of power through means that undermine, humiliate, denigrate or injure the recipient.

Behaviour that is considered bullying by one person may be considered firm management by another. Most people will agree as to what constitutes extreme cases of bullying and harassment but it is often the grey areas that cause the most problems. It is good practice for employers to provide their staff with examples of what constitutes unacceptable behaviour, including:

  • Spreading malicious rumours, or insulting someone by word or behaviour
  • Ridiculing or demeaning someoneExclusion or victimisation
  • Unfair treatment
  • Overbearing supervision or other misuse of power or position
  • Deliberately undermining a competent worker by overloading and constant criticism
  • Preventing individuals progressing by intentionally blocking promotion or training opportunities.

Unless bullying amounts to conduct defined as harassment in the Equality Act 2010, it is not possible to make a complaint to an employment tribunal. The Act uses a single definition of harassment to cover the relevant protected characteristics. Employees can complain about behaviour that they find offensive, even if it is not directed at them.

Harassment is defined as: “Unwanted conduct related to a relevant protected characteristic, which has the purpose or effect of violating an individual’s dignity or creating an intimidating, hostile, degrading, humiliating or offensive environment for that individual”. The relevant protected characteristics are age, disability, gender reassignment, race, religion or belief, sex, and sexual orientation.

An employee can make a complaint against their employer if they are harassed by someone who doesn’t work for that employer, such as a customer. As an employer, once you are aware of this unwanted behaviour, you should take reasonable and proportionate action to address it.

Pharmacy owners owe their employees a ‘duty of care’. If the mutual trust and confidence between employer and employee is broken, for example, through bullying and harassment, an employee can resign and claim constructive dismissal at an employment tribunal on the grounds of breach of contract.

Breach of contract may also include failure to protect an employee’s health and safety at work. Under the Health and Safety at Work Act 1974, employers are responsible for the health, safety and welfare at work of all employees.

Employees can also bring a negligence claim on the grounds that their employer has failed to protect them from bullying, which has led to personal injury (normally in such cases, psychiatric illness).

Prevention

Addressing bullying in the workplace can be difficult. However, making a grievance procedure or dignity-at-work policy accessible certainly helps; employees will know what to do if they think they are being bullied, which, in most instances, is to bring it to the attention of their managers.

Policies for owner-managed or small- chain pharmacies do not need to be over elaborate, and might be included within other personnel policies, but a checklist for a specific policy on bullying and harassment could include:

  • A statement of commitment from senior management
  • A clear statement that bullying and harassment is unlawful and will not be tolerated
  • The steps which the organisation takes to prevent bullying and harassment
  • Responsibilities of supervisors and managers
  • Confidentiality for any complainant
  • Reference to grievance procedures (formal and informal), disciplinary and investigation procedures including timescales for action, and counselling and support availability
  • Training
  • How the policy is to be implemented, reviewed and monitored.

Good practice requires that all allegations of bullying are investigated thoroughly and impartially. The investigation should include interviewing the employee who raised the allegation, the alleged perpetrator, and any possible witnesses to the alleged events, who would normally be co-workers. Having done so, you should report back to the employee on your findings. You should establish with the employee what steps can be taken in the future to ensure that they are supported and comfortable at work.

A proactive approach helps protect your business from problems in this area. Setting a good example and disseminating clear guidance communicates to all staff that bullying and harassment are unacceptable.

For more information please contact: 



Richard Hough
Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com
 


Pharmacist work place pressure

Tuesday 13th December 2016

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Independent Community Pharmacist magazine article - November 2016

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

Negative publicity surrounding pharmacy in an article published by the Guardian earlier this year has prompted the General Pharmaceutical Council to look into issues of workplace pressure which affect pharmacy professionals.

The Guardian article restricted its findings to the practices of one particular pharmacy chain but a survey undertaken by the Pharmacists’ Defence Association’s survey, and reaction to it, indicates that the issue of workplace pressure suffered by pharmacy professionals is widespread.

For a number of years now, changes to the pharmacist’s role, pressures to meet business targets, staff shortages, long working days with no opportunities for rest breaks, and an increasing administrative burden, have left pharmacists struggling to cope with burgeoning workloads and have led to concerns that patient safety is being compromised.

The article highlighted medicine use reviews (MURs) as an example of how financial targets were being inappropriately set by some employers. Many employers construe the annual MUR limit, which was set to prevent the system from being abused, as a target. The pressure on pharmacy professionals to meet this target has led to some pharmacists performing MURs inappropriately and in some cases falsifying MURs.

In addition to the financial targets, the staffing levels, workload and unavailability of rest breaks not only increases the pressure on pharmacy professionals but also increases potentially unsafe practices such as “self-checking”. This results in an environment where dispensing errors are more likely to occur, which threatens the safety of patients.

In addressing this issue, pharmacy owners and pharmacists should take into consideration the following applicable guidance and legislation.

Standards of Conduct, Ethics and Performance (the Standards)

The Standards state that a pharmacy professional must make patients their first concern. They also state that professional judgement should not be affected by personal or organisational interests, incentives, targets or similar measures. In other words, inappropriate financial targets imposed by management within pharmacy businesses not only increase the pressure on pharmacy professionals but, in attempting to meet those targets, registrants may be in breach of the Standards.

Working Time Regulations 1998 (WTR)

The lack of rest breaks and excessive working hours, which many pharmacy professionals endure, are not compliant with the WTR. The WTR introduced rules of general application limiting working hours and providing for rest breaks and holidays. In relation to pharmacy practice, an employer's obligations under the WTR are as follows:

  • Take all reasonable steps in keeping with the need to protect workers' health and safety to ensure that each worker's average working time (including overtime) does not exceed 48 hours per week.
  • Give workers "adequate" rest breaks where the pattern of work is such as to put their health and safety at risk, in particular where work is monotonous.
  • Allow workers the following rest periods unless they are exempt, in which case compensatory rest will usually have to be given:
    • 11 hours' uninterrupted rest per day;
    • 24 hours' uninterrupted rest per week (or 48 hours' uninterrupted rest per fortnight); and
    • a rest break of 20 minutes when working more than six hours per day.

Often it is difficult for pharmacy professionals to take a 20 minute break due to customer expectation that a pharmacist will always be present during a pharmacy’s opening hours and the commercial pressures to meet these expectations.

Pharmacy owners must ensure that workers can take their rest breaks but are not required to force workers to take them. Workers can elect to work through a rest break provided they do not risk their own or others’ health or safety and if they do so, it is the employer’s responsibility to ensure that compensatory rest is allocated.

Medicines Act 1968

Under the Medicines Act 1968, pharmacists can still commit a criminal offence through making an inadvertent dispensing error.

Experts on medical safety all agree that the threat of criminal liability constitutes a disproportionate response to human errors, making dispensing practice less safe and more defensive, with errors going unreported. Consequently, effective clinical governance and risk management are significantly affected.

There has been a long-standing call for the repeal of the relevant provisions of the Medicines Act. Many commentators consider that, where action is required, it should be the GPhC, exercising its regulatory powers, and not the criminal courts, who should have the powers to deal with the issue.

On 12 February 2015, the Department of Health published a consultation seeking views on the draft Pharmacy (Preparation and Dispensing Errors) Order. The consultation ran until 14 May 2015 and proposed to “redress imbalances between legislation and regulation.” However, a report on the responses to the consultation questions has yet to be published.

It is clear that common working practices within the profession constitute breaches of both the Standards and WTR and contribute to workplace pressure, which is detrimental to pharmacy professionals and puts patients at risk. Pharmacy professionals who are put under this pressure are far more likely to make an honest human error and run the risk of facing criminal sanctions.

Pharmacy owners, employees and locum pharmacists must each take responsibility for decreasing avoidable workplace pressure and continue to push for reform of the Medicines Act 1968.

For more information please contact:


Richard Hough

Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com


Falsified Medicines Directive and Brexit Fallout

Friday 9th December 2016

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The European Union Intellectual Property Office (EUIPO) has estimated in a recent report that the manufacture and wholesale supply of counterfeit medicines incurs a direct cost to the EU pharmaceutical sector of:

  • 37,000 jobs
  • EUR1bn of government revenue
  • EUR10.2bn of sector revenue

The UK pharmaceutical sector alone loses an estimated EUR605 million of sales annually from the counterfeit medicine trade. The EUIPO report notes that the indirect effect of counterfeit medicines inflates these figures higher still, and that the estimates do not take into account pharmaceutical retailers. The impact of counterfeit medicine sales is more than just an economic issue; counterfeit medicines also put at risk the wellbeing of those who take them.

The Falsified Medicines Directive (FMD) was published in 2011 in the Official Journal of the European Union to counter these massive losses, and has been in force since 2 January 2013.  The purpose of the FMD, and delegated legislation which has subsequently been adopted pursuant to it, is to add a layer of EU-wide regulation in relation to the supply of medicines, including changes to the outer packaging of medicines, an EU-wide logo to identify legal online suppliers of medicines, more stringent control and inspections of producers of active pharmaceutical ingredients, and stronger record-keeping requirements for wholesalers.

The ‘delegated legislation’ has manifested itself as supplementary regulation EU2016/161, which shall apply in all EU Member States from 9 February 2019. From that date, manufacturers of pharmaceutical products must employ specified safety features, including a unique 2D data matrix code and tamper-resistant measures, on the packaging of medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it ‘will continue to work with the European Commission and other Member States on implementation plans for the new regulation’, and that ‘we will also be working with stakeholders throughout the supply chain to secure implementation within the three years’. However, the UK’s decision in June to leave the EU somewhat muddies the waters.

The UK is expected to trigger Article 50 at some time during spring 2017, which will in turn initiate the two year negotiation process pending a subsequent exit from the EU. What is not clear is whether EU law will remain enshrined in the UK to be repealed at will, or if the proverbial slate will be wiped clean. One can imagine a scenario where a healthy middle ground will be found, however for now the future of EU-derived pharmaceutical law, such as the FMD, is uncertain.

A number of pharmaceutical bodies have initiated consultations with the UK government in order to decipher and prepare for possible post-EU scenarios. The British Generic Manufacturers Association, the Association of the British Pharmaceutical Industry and others have published press releases which support the current EU regulatory framework.

The future of the FMD remains uncertain, however the UK pharmaceutical industry has, to this point, remained fiercely supportive of EU pharmaceutical law, and looks set to push for full implementation of the FMD. 

For more information please contact:


Richard Hough

Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com


GMC Investigation – Inappropriate Prescribing

Wednesday 7th December 2016

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The General Medical Council (GMC) has launched an investigation following claims of inappropriate prescribing of antibiotics by doctors who are linked to online pharmacies. The action was prompted by a BBC investigation, which highlighted that the doctors associated with these online pharmacies were prescribing antibiotics in a manner contrary to the National Institute for Health Care and Excellence (NICE) guidelines, and on occasions at odds with the symptoms listed by the journalist.

The BBC’s investigation comes at a time when bacterial resistance to antibiotics is high on the medical agenda as a result of years of over-prescribing. Highlighting the lack of cohesion in primary care, and perhaps a failure to adhere to prescribing guidelines, one BBC journalist was able to obtain three prescriptions for antibiotics within 24 hours using online pharmacies. In light of the fact that in Europe alone, over 25,000 people per year die as a result of ultra-resistant bacteria, this story illuminates the fundamental failings of a fragmented primary care service offering, in which online prescribing and dispensing services are becoming increasingly common.

The GMC has released a statement in response to the BBC investigation, claiming ‘it is important that every practising doctor in the UK reflects on current guidance’. Niall Dickinson of GMC has previously remarked ‘doctors who pose a risk to patients can, and do, face sanctions for mis-prescribing’, though no method of direct and formal punishment for casual over-prescribing currently exists.

NICE guidelines state ‘When deciding whether or not to prescribe an antimicrobial, take into account the risk of antimicrobial resistance for individual patients and the population as a whole’. Whether or not such guidance - and inaction to implement it - attracts legally enforceable measures in the future remains to be seen.

Pharmacy owners, especially those operating online pharmacies which dispense as a result of an online GP consultation, should take heed of the investigation as tougher enforcement by regulatory authorities would appear inevitable. However, this issue will not disappear until there is greater cohesion between primary care service providers, especially those operating online. 

For more information please contact:


Richard Hough

Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com


Fitness to Practice Proceedings

Wednesday 5th October 2016

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Independent Community Pharmacist magazine article - September 2016

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

The vast majority of pharmacists are dedicated professionals who conduct themselves in exemplary fashion and abide by both the law and the profession’s accepted standards of conduct, ethics and performance.  Regrettably, the actions of some registrants occasionally fall beneath accepted standards and, in some circumstances, the scope or gravity of those actions is such that the registrant’s fitness to practise is called into question.

The Pharmacy Order 2010 contains provisions which govern when a pharmacist’s fitness to practise may be called into question. Regulation 51 states that a registrant’s fitness to practise is to be regarded as ‘impaired’ only on a limited number of grounds, the main ones being:

  • Misconduct;
  • Deficient professional performance;
  • Adverse physical or mental health;
  • A conviction for a criminal offence; and
  • Accepting a police caution.

Engaging in behaviour which is considered to be inappropriate, misleading or dishonest, which breaches the GPhC’s Standards of Conduct, Ethics and Performance or which breaches medicines or criminal legislation is likely to warrant further investigation. Certain health issues, such as suspected alcohol or drug abuse or psychiatric problems, are also likely to be investigated. 

When an allegation, relating to behaviour which exceeds the GPhC’s threshold criteria, is made to the GPhC, the Registrar must, in most cases, refer the matter to the Investigating Committee (“the IC”) for consideration. More serious allegations may, however, be referred directly to the Fitness to Practise Committee (“the FTPC”). The IC will decide, by reference to referral criteria, whether the allegation needs to be considered by the FTPC. If it decides not to refer the matter to the FTPC, it may decide to take no further action against the registrant, issue a warning or provide advice to the registrant in connection with any matter arising out of, or related to, the allegation. Where an allegation is referred to the FTPC, it must determine on the facts whether the registrant’s fitness to practise is impaired. 

We would always advise our clients to seek legal advice at the earliest opportunity, so that representations can be submitted on behalf of the registrant for early consideration by the IC, rather than to wait before the matter comes before the FTPC.

If the matter proceeds to a FTPC hearing, various legal documents, including the Particulars of Allegation, which sets out the full extent of the allegations, will be sent to the registrant, together with statements from witnesses called by the GPhC. Together these documents constitute the GPhC’s case against the registrant.

Upon service of the GPhC’s case, the registrant will be able to consider the supporting evidence, the robustness of which will determine in many cases whether the registrant will admit, dispute or partly admit the allegations.

Fitness to practise hearings are held in public before a tribunal consisting of a legally qualified chairman and two lay members. Proceedings commence with the FTPC considering preliminary legal arguments brought by the parties’ legal representatives. The allegations against the registrant are then read out including the alleged facts upon which the allegations are based. 

FTPC hearings follow a three stage process (findings of fact; whether the registrant’s fitness to practise is impaired; and sanction). The FTPC will make findings of fact based on admissions and cross-examination of each side’s witnesses. The second stage involves further submissions from the parties as to whether, on the basis of any facts found proved, the FTPC finds the registrant’s fitness to practise is impaired. 

Before the FTPC imposes any sanction, the parties’ representatives make further submissions regarding any relevant mitigating or aggravating circumstances. At this third stage, the FTPC will also consider testimonials regarding the registrant’s character and/or his clinical abilities if relevant. 

The FTPC will refer to the GPhC’s Good decision making: fitness to practise hearings and sanctions guidance, which sets out the available sanctions, the circumstances when these may be imposed and commonly occurring mitigating and aggravating factors.  When imposing any sanction, the FTPC will have regard to the principle that the purpose of a sanction is to protect the public, maintain public confidence in the profession and to maintain proper standards. 

The FTPC may impose the following sanctions:

a)     Take no action, in which case no record will be made on the Register;

b)    Give advice, if no impairment is found. No record of the advice is made on the Register;

c)     Give a warning, details of which will be recorded in the Register;

d)    Impose conditions on the registrant’s registration for a period of up to three years, which will  be recorded in the Register; 

e)     Suspension for a period not exceeding 12 months, which will  be recorded in the Register; or

f)     Removal from the Register.

After the imposition of a sanction, the matter will normally end there.  However, those who wish to fight on may exercise their right of appeal, which must be lodged in the High Court (in England) within 28 days of the FTPC’s decision. 

Undoubtedly, a GPhC investigation can be an extremely traumatising experience but to mitigate this and to try and get the best possible outcome, we recommend getting good advice early on in proceedings. 


Hub and spoke dispensing

Thursday 29th September 2016

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Independent Community Pharmacist magazine article - September 2016

Press clipping: Pharmacy and the Law Copyright CIG Ltd.

Earlier in the year, the Department of Health (‘DoH’) published a consultation document entitled, ‘Amendments to the Human Medicines Regulations 2012: ‘Hub and spoke’ dispensing, prices of medicines on dispensing labels, labelling requirements and pharmacists' exemption’.

The consultation sought comments from interested bodies on four proposed changes to the Human Medicines Regulations 2012 and the Medicines Act 1968 with the aim to introduce new legislation1 in October 2016, which would:

• Enable the use of ‘hub and spoke’ dispensing models by ‘spoke’ pharmacies that do not form part of the same retail pharmacy business as the ‘hub’ pharmacy;

• Permit dispensing labels to include the indicative cost of a medicine;

• Clarify the dispensing label requirements for monitored dosage systems to reflect current practice and by ensuring products supplied under patient group directions have a dispensing label in line with professional guidance; and

• Redesign the ‘exemptions for pharmacists' in section 10 of the Medicines Act 1968 in respect of the preparation and assembly of medicines, further to a recent judgment of the Court of Justice of the European Union2.

Of these four proposals for legislative change, the first has arguably proved to be the most contentious because, if it was adopted, it could have far-reaching consequences for pharmacy proprietors.

‘Dispensing’ covers a number of different processes, including the receipt of a prescription, clinical and accuracy checks, and the sourcing, preparation, assembly and supply of medicines. Traditionally, all of these different aspects of dispensing are undertaken in a single pharmacy. In a hub and spoke model, however, some of these processes are undertaken in another pharmacy. As the law currently stands, hub and spoke dispensing may only occur between pharmacies in the same retail business (the intra-group model) and has therefore been adopted by some of the multiples.

The DoH claims that the intra-group model is gaining popularity due to its potential to make the dispensing process more efficient, lower operating costs and free up pharmacists to spend more time with patients. The consultation papers goes on to state that the “model allows for cost advantages to be exploited by expanding the scale of assembly and preparation, which makes automation more viable. Automation in dispensing, implemented alongside a robust quality assurance system, is linked to safer dispensing with fewer dispensing errors. Large scale 'hub' pharmacies have the capability to increase efficiency and lower operating costs significantly”.

The above claims have proved to be contentious, predominantly on the basis that they appear to be baseless, and have been met with resistance by pharmacy bodies, which consider that the DoH, in attempting to sugar the unpalatable funding cut pill that it is forcing contractors to swallow, has considerably overstated the perceived benefits of this model.

Section 10 of the Medicines Act 1968 only allows hub and spoke dispensing if the hub and the spoke pharmacy are both part of the same retail pharmacy business. The proposed legislative change seeks to remove this restriction, which would then allow hub and spoke dispensing models to operate between different legal entities (i.e. on an inter-group, as opposed to intra-group, basis). The inter-group model would make it possible for independent spoke pharmacies either to use the services of hub pharmacies that are part of a separate business or collaborate with other independents and invest in automation in one hub location.

There are different types of hub and spoke dispensing, depending on the method by which and whether the hub or the spoke is the entity which supplies directly to the patient. Irrespective of the type of hub and spoke model adopted in practice, the consultation document envisages that patients would always have access to a pharmacist and both the hub and the spoke operations would be required to be registered pharmacies.

However, the proposed model raises a number of legal issues in respect of accountability, compliance with other European legislation, where liability would lie and also in respect of data protection and data sharing between different legal entities, all of which would need to be satisfactorily addressed before any inter-group hub and spoke model could be adopted.

Due to significant concerns that were raised in response to the consultation, not least the inconsistencies between the proposals set out in the consultation and the wording of the published draft legislation, including the apparent widening of the proposals to allow for hub and spoke dispensing in “relevant clinical settings” (a term which is broad enough to include surgeries), the government announced that it would, for the time being at least, suspend the progress of the draft legislation and take time to further engage with stakeholders.

So for the time being at least, hub and spoke dispensing must remain within the same company, and the government will have to go back to the drawing board and either back up the merits of the inter-group model with robust evidence or find an alternative way to appease disgruntled contractors on whom it has forced such swingeing funding cuts.

1 Human Medicines (Amendment) (No.2) Regulations 2016
2 Judgment of the Court (Third Chamber) of 16 July 2015; Abcur AB v Apoteket Farmaci AB (C-544/13) and Apoteket AB and Apoteket Farmaci AB (C-545/13) 
 
For more information please contact:


Richard Hough

Partner and Head of Healthcare at Brabners LLP
Tel:  0151 600 3302
Email: richard.hough@brabners.com


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