A pharmaceutical industry scientist who falsified test results for an anti-cancer drug has been jailed for three months.

Steven Eaton, 47, faked research data on an experimental drug in 2009 to persuade his employer, Aptuit, to fund clinical tests of the drug.

His bogus data, which made a failed test appear successful, could have resulted in an unsafe drug being tested on humans.

Aptuit, a US company at whose Edinburgh R&D site Eaton was employed, identified the fraud and reported Eaton to the Medicines and Healthcare Products Regulatory Agency (MHRA).

An MHRA investigation revealed that Eaton had been inaccurately reporting data since 1993.

Eaton is the first researcher to be found guilty of breaking the Good Laboratory Practice Regulations (1999).

Sheriff Michael O’Grady commented: “My sentencing powers in this are wholly inadequate. You could have caused cancer patients unquestionable harm.”

Gerald Heddell, the MHRA’s director of inspection, enforcement and standards, said: “This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.”

Sativex, the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant, has had its restrictions lifted after concerns over its misuse and addictive potential were calmed.

The UK Home Office had originally stated the spray had to be stored in a lockable refrigerator or one not visible to the general public and prescribed a long with certain criteria.

But following advice from the Advisory Council on the Misuse of Drugs (ACMD), the Home Office ruled the drug no longer has to be locked away.

Professor John Zajicek, Consultant Neurologist at Derriford Hospital, Plymouth, said the lifting of the restrictions is “good news for healthcare professionals involved in the prescribing, supply and storage of Sativex.”

Concerns were initially raised about levels of abuse and addiction by the ACMD after it was approved for use by the MHRA in June 2010. But the Council has now recognised the low abuse potential and low diversion risk of the treatment and changed its original recommendation.

The spray is indicated as a treatment for adults with moderate to severe spasticity due to multiple sclerosis (MS) who have failed to respond to other treatments. It is only available on prescription from a physician with experience in treating MS spasticity.

A new quadrivalent (four-strain) vaccine for seasonal influenza has been approved by the MHRA for use in the UK.

Fluarix Tetra from GSK, which has also been approved for use in Germany, is the first vaccine of this type to gain regulatory approval in Europe.

The vaccine is approved by the MHRA for the immunisation of adults and children aged over three years, and was approved in the US in December 2012.

It offers protection against two subtypes of the influenza A virus and two of the B virus, widening the scope of the trivalent flu viruses currently in use.

GSK commented: “As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine.”

The new vaccine is expected to be available to the NHS by autumn 2013, the start of the flu vaccination season.

Sanofi Pasteur and Novartis are both working on quadrivalent flu vaccines, while AstraZeneca has one on the market in the US.

The Department of Health has published a ‘pledge’ to improve health outcomes for children and young people through co-ordinated activity across the NHS.

Stated aims include a reduction in the child mortality rate, improved care for children with long-term conditions, and better mental health care for the young.

A new Children and Young People’s Health Outcomes Board, led by the Chief Medical Officer, will focus on improving outcomes across paediatric care.

The DH is responding to a report from the Children and Young People’s Health Outcomes Forum, warning that child mortality rates in England are among the worst in Europe and that 26% of children’s deaths are linked to failures in direct care.

The Forum calls for attention to obesity, maintenance of long-term conditions, earlier diagnosis of mental health disorders, and better attention to the health needs of looked-after children.

GPs will be offered specialised training or support in paediatric health, and provided with new colour-coded health maps showing trends in conditions such as asthma and diabetes.

The CCGs will be asked to review their provision of services for children and investigate poor outcomes.

The DH also said it would investigate proposals by the Royal College of General Practitioners to extend GP training for a fourth year to include child health and mental health.

Health Minister Dan Poulter said: “It is a shocking fact that child mortality in Britain is the worst when compared to other similar European countries. There is unacceptable variation across the country in the quality of care for children – for example in the treatment of long-term conditions.

“Our pledge demonstrates how all parts of the system will play their part and work together to improve children’s health.”

Hilary Cass, President of the Royal College of Paediatrics and Child Health, commented: “It’s crucial that this momentum is maintained and that outcomes are regularly measured to drive improvements.

“We will be directly involved in a number of areas, which include enhancing the use of medicines in children and working with GPs to ensure paediatrics is part of their training.”

Signatories to the pledge include the DH, Healthwatch, the NHS Commissioning Board, NICE, MHRA and Public Health England.

A key principle of the pledge is that improving children’s health outcomes will not only reduce child mortality but lay the foundations for healthier adult lives.

A BBC investigation has exposed nine London pharmacies that sold prescription-only drugs, including powerful sedatives, for cash.

Undercover reporters were sold sedatives (Valium and temazepam), opiates (Oramorph), antibiotics (amoxicillin) and Viagra for much higher prices than the cost of a prescription.

The BBC’s Inside Out programme has led to calls for stronger controls over pharmacies, which legally can provide such drugs without a prescription only in an emergency.

The easiest of the drugs to obtain by this illegal route were Valium (diazepam) and amoxicillin.

All of the illegal drug sales provoked concern from medical experts:

• Diazepam and temazepam are highly addictive and fatal overdoses are common.

• Oramorph (a bottle of which was purchased by a journalist for £200) is a potent oral form of morphine.

• Antibiotics are widely over-used, leading to poor patient response and the development of antibiotic-resistant disease strains.

• Viagra is dangerous for patients with cardiovascular disease.

Sedatives such as Valium are not controlled as strictly as opiates, but are widely linked to addiction, abuse and overdose.

There is concern that the overlapping regulatory roles of MHRA and the General Pharmaceutical Council (GPhC) may be leading to poor control over some widely prescribed drugs.

The GPhC has the power to cancel a pharmacist’s right to practise, but does not compile a list of pharmacies known to have sold drugs illegally.

Children’s healthcare in England needs to be more integrated, timely and focused on individual needs, the Children and Young People’s Health Outcomes Forum has said.

The Forum’s recommendations, proposed as the basis of a national strategy, include a strong emphasis on pharmacovigilance and avoiding the use of off-label medications.

Other key recommendations relate to the goal of “joined up” care, seeking to address gaps in the consistency and continuity of children’s healthcare.

The report describes the view that children in England are well cared for as “sentimental and complacent”, and states: “the UK is worse than other countries in Europe for many outcomes that could be improved through better healthcare and preventative interventions”.

To address this situation, the report argues, it is vital for children and young people to be more involved in decisions about their care; for GPs and other clinical staff to have better training in paediatric care; and for healthcare to meet the changing needs of the young individual over time.

Four new outcome indicators are proposed:

• time from first NHS presentation to diagnosis or start of treatment

• integrated care – developing a new composite measure

• effective transition from children’s to adult services

• age-appropriate services, with particular reference to teenagers.

More generally, the report recommends that all NHS organisations “should take a life-course approach, coherently addressing the different stages in life and the key transitions instead of tackling individual risk factors in isolation”.

It also calls for better systems to allow sharing of information between care providers in different sectors, with “sentinel conditions and pathways” being selected to help identify “gaps in services, including prevention”.

The report notes high levels of medication error and use of off-label or unlicensed medications with children, and calls on the MHRA to prioritise these issues “in line with the new EU legislation effective in July 2012”.

To improve the evidence base for healthcare, it recommends breaking down health data for the first two decades of life into five-year age bands.

To improve clinical leadership, it says, the NHS Commissioning Board should appoint a National Clinical Director and CCGs should appoint a senior clinical lead in this area.

Finally, it recommends that the QOF and PbR systems for child healthcare should be developed and improved.

As the era of blockbuster drugs draws to an end, the pharmaceutical industry is looking to fresh markets and new models of drug development while facing legislative changes as well as economic threats. Sarah Hanson looks at what lies ahead for the industry in 2012.

2012 looks set to be the year when pharmaceutical companies face their scariest outlook: peering over the brink of a patent cliff. Major pharmaceutical companies are realising that they can no longer rely on a broken business model that is dependent on blockbuster drugs, and are looking for alternative ways to maintain profits and cover the loss of revenues due to patent expiry. This throws up a host of commercial, legal and regulatory challenges.

Entering new markets
Major structural shifts are taking place in R&D and how intellectual property is financed, meaning that the life sciences sector is providing a rare bright spot in the pervading economic gloom. Over the last decade, there has been almost US$700bn worth of deals in the pharmaceutical sector, which remains one of the prime industries in terms of M&A activity. Now we are likely to be at the start of a fresh cycle of M&A activity in the industry, with a particular focus on emerging markets (BRIC, South-East Europe and Turkey) where the portfolios of many pharma companies remain weak.

Japan has enjoyed a particularly busy year in terms of pharmaceutical M&A: across all sectors, cross-border acquisitions by Japanese companies nearly tripled relative to 2010. Liquidity among Japanese pharma companies remains strong, as does demand for prescription medicines from an ageing population, enabling Japanese companies to enter into deals at a time of intense competition for intellectual property in the industry. In 2011 Takeda, the largest Japanese pharmaceutical company, completed its €9.6bn (debt-free, cash-free) acquisition of Swiss drug company Nycomed. On the back of this transformative deal, we expect the industry to undertake more M&A activity in Japan in 2012. Factors such as the economic climate, demography and the state of R&D pipelines should see more Asian acquisitions of European patented drugs.

Emerging markets also continue to receive significant life science private equity (PE) investment, with China and India gaining the most. Historically, the risk involved in R&D has led PE firms to avoid large pharma companies and the biopharma industry in general. However, recently some small deals have linked PE and venture capital with biotechnology, and we are seeing investment in a number of diverse projects in different life science areas. This growing trend is already playing out in Europe – according to the European Private Equity and Venture Capital Association, the total investment in life sciences in Europe increased from €3.4bn in 2009 to €5.7bn in 2010, while the total venture investment in life sciences accounted for 30% of the total investment in Europe in 2010. Such funding is likely to increase as the cash-rich life sciences sector is seen to be ’recession proof’.

A helping hand for R&D
Pharmaceutical companies looking to weather the storm of patent expiry on key products are also looking to diversify their pipelines and develop replacement products. With most companies struggling to make a return on high R&D costs pumped into prospective pipelines, additional support is vital.

In the UK, the Government hopes its new Patent Box legislation will give a welcome boost to research and development. When it comes into force in April 2013, the Patent Box will reduce UK corporation tax on patent profits to 10%, encouraging R&D activity and providing incentives for companies to retain intellectual property in the UK. This will make the UK competitive with other European countries such as Ireland, Switzerland and Hungary, which have had similar systems in place for years. While the existing system of R&D tax credits has given some relief for R&D expenditure, there has until now been no similar incentive for businesses to retain their IP in the UK once it has been created.

Legislation such as Supplementary Protection Certificates (SPCs) will also play a significant role in assisting companies facing the expiry of major patent portfolios and provide more protection for companies investing heavily in R&D. EU patent offices have long been able to grant SPCs where there has been a large gap for a company between filing a patent application and getting authorisation to market a drug. However, legal issues surround how SPCs apply to medicines that contain more than one active ingredient. In a landmark case in November 2011, the Court of Justice of the EU said that there is no reason why an SPC may not be granted for a single active ingredient that is specified in a patent where the marketing authorisation also contains other active ingredients. This (and other recent cases regarding SPCs) is likely to have further ramifications in battles between generic and pharmaceutical companies into 2012.

New legislation: help or hindrance?
New legislation coming into force will also have an impact on the pharma industry in the year ahead. Whether the expected IP and regulatory legislation will help or hinder pharmaceutical companies in this challenging climate remains to be seen.

A number of significant regulatory issues are being debated in Europe. A Directive is being developed to improve the EU pharmacovigilance system, simplify regulatory decision-making, provide a legal basis for more proactive pharmacovigilance by both regulatory authorities and the industry, and involve patients more closely in reporting adverse drug reactions. Though it was adopted in 2010, compliance is not compulsory until 2012. The legislation will bring about the most profound change to the legal framework since 1995, when the EMA was set up. The European Commission, EMA and Member States have been carrying out work to implement the legislation, but companies still lack clarity on many of the new obligations. It is likely that the new requirements will be introduced in phases beyond the original July 2012 implementation deadline.

At a time when social networking continues to grow and become part of the daily routine of many working lives, pharmacovigilance is particularly important. The pharma industry must recognise that social networking and reporting are taking on a rapidly-increasing significance in the marketing, discussion and exchange of information concerning drugs. There are pharmacovigilance obligations at all stages of the life cycle of a medicine and the process of drug monitoring; the pharmacovigilance system will need to take account of this, not least because the increasing use of social media also poses interesting questions around geographical legal jurisdiction.

Discussions continue about the introduction of a Directive that would require substantial changes to the regulation of clinical trials. In March 2010, the Chancellor of the Exchequer announced that the Government would review the UK’s implementation of the Clinical Trials Directive in order to reduce perceived gold-plating and to increase the proportionality of the system. The MHRA has stated that it intends to wait for the outcome of the European negotiations before reviewing and amending the UK legislation.
2012 may also herald significant changes in the way drugs are marketed. EFPIA in particular will be under the spotlight this year as the implications of amendments to the advertising of medicines become apparent. Currently, the advertisement for a medicine must be in line with the product’s Summary of Product Characteristics (SmPC). Hence off-label promotion is not allowed. EFPIA has approved an amended Code of Practice on the promotion of prescription-only medicines to, and interactions with, healthcare professionals.

The changes to the Code make allowance, for example, for the provision of a limited number of samples to healthcare professionals for a limited time (Art. 16).  Previously, following EU Directive 2001/83/CE, the provision of samples was not allowed (due to concern over inducement); but in accordance with national and/or EU laws and regulations, a limited number of medical samples may now be supplied on an exceptional basis and for a limited period. A reasonable interpretation of this provision is that each health professional should receive, per year, not more than four medical samples of a particular medicine that he/she is qualified to prescribe for two years after he/she first requests samples of that particular medicine.

A landmark year
Last year saw significant developments for the pharma industry – and for lawyers – which look set to continue through 2012. With deals such as Takeda’s acquisition of Nycomed in 2011, we expect the trend of commercial and economic power shifting eastward to continue. Increased diversification, coupled with regulatory hurdles, will set a challenge for the pharma industry. Whether companies will survive and thrive on this challenge remains to be seen as the year unfolds, but the structural upheaval felt as a result of life beyond the patent cliff is already being witnessed.

Sarah Hanson is a partner at CMS Cameron McKenna: the UK branch of CMS, a leading European provider of legal and tax advice.

Together with its health reforms, the UK Government has developed a programme to accelerate the uptake of innovative therapies in the NHS that is not only ambitious but concrete and immediate. Thoreya Swage examines the new innovation agenda and what it offers to the pharma industry.

Although the main focus of Government health policy is reform, the development of new commissioning processes and structures and saving £20bn of annual NHS spend, the powers that be at the top at the NHS are still keen on accelerating the adoption of innovation in healthcare.

With that in mind a document, Innovation Health and Wealth, was published in December 2011 by the DH to speed up the process by establishing a set of measures to support change in the practice of healthcare and to identify a timetable for implementation. Unlike similar exhortations in the past to ‘speed up innovation’, this document has a sense of urgency, with a requirement to start immediately and build the actions set out in the report in the planning cycle for 2012–13.

The document recognises that by adopting innovation, the NHS can improve its own productivity – essential for achieving QIPP. It can also provide much-needed support to the life sciences industry at home and abroad through exporting new ideas and expertise, working in partnership with UK industry and generating new business for UK-based companies.

Of course, the ultimate outcome is to improve patient care.

What’s in store?

Innovation is defined in the document as “an idea, service or product, new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied”. The term covers a wide range of processes, technologies and uses of pharmaceutical products. The main thrust of the document is to ensure that change is disseminated throughout the NHS, and does not remain in isolated pockets in the more progressive parts of the healthcare system.

The listed barriers to the dissemination of new ideas are probably familiar to all in the pharma industry. They include:

• limited access to data and information

• lack of recognition of those who innovate

• inflexible financial levers that oppose change

• commissioners not having the tools or capability to drive innovation

• lack of consistent leadership to support change

• poor structure and processes to drive innovation.

The actions are highlighted to overcome these barriers are listed below.

1. Ensuring compliance with new ideas

In addition to introducing a value-based pricing structure for new medicines from 2014 – to ensure that patients can access effective treatments that reflect their value, the Government plans to set out in statutory form a NICE Compliance Regime that attaches funding to NICE Technology Appraisals in order to ensure rapid and consistent implementation throughout the NHS, so that patients receive the clinically and cost-effective technologies and medicines their doctors believe they need.

There will also be a requirement for all NICE Technology Appraisals to be added to relevant local NHS formularies, and a NICE Implementation Collaborative (NIC) will support timely implementation of NICE guidance. The NIC will be made up of the NHS Commissioning Board, NICE, the Chief Pharmaceutical Officer, the NHS Confederation, the Clinical Commissioning Coalition, the Royal Colleges and the life sciences industry. It will identify areas that require support and develop implementation guidance and solutions for the NHS, as well as helping pharma companies to improve their value propositions to NICE.

2. Improving information

There will be a single comprehensive web portal for innovation in the NHS, which, among other things, will ‘showcase’ and exchange ideas, and an ‘innovation scorecard’ to track compliance with NICE Technology Appraisals. Both of these will be available publicly.

The web portal will hold a database of case studies, implementation guides and tools, and e-learning programmes for clinical staff to support the introduction of new practice.

A later development will be the inclusion of the existing database of current clinical trials for drugs and medical technologies, which permits patients to participate in clinical studies. The aim will be to encourage more patients to get involved in research and so generate better data for new interventions.

Public awareness of innovations will be driven by consumer campaigns – developed by Which? – to promote effective new ideas in health.

A secure data linkage service will be set up by the Health and Social Care Information Centre by September 2012. ­ This will provide data extracts based on information generated by primary and secondary care and other sources, permitting an improved understanding of which interventions work best, when and why. A complementary secure data service, the Clinical Practice Research Datalink (CPRD) will be set up by the MHRA to support the needs of life science researchers.

3. Architecture for delivery of innovation

­This is a key action through which more robust relationships will be developed between academia, science and industry to develop solutions to healthcare problems and ensure the dissemination of ideas. A designated number of Academic Health Science Networks (AHSNs) will be established nationally, with the first to go live during 2012–13. Every NHS organisation will be affiliated to its local AHSN, which will act as a gateway for NHS professionals requiring help with innovation and provide industry with a point of access to the NHS. Details of the designation process will be published this spring.

The many existing organisations that have been set up to support innovation will be rationalised in a review of all DH/NHS-funded or sponsored bodies.

4. Incentivising innovation

­The funding structure of the NHS will be altered to allow savings yielded to be used for innovation, to prevent ‘silo budgeting’ and to permit cross-boundary working. Tariffs for healthcare will continue to be developed on the basis of outcomes, thereby promoting cost-effective approaches. At the local level, there will be opportunities to use existing tariffs flexibilities to improve care through the development of ‘Best Practice’ tariffs.

NICE will be responsible for stating which activities and tariffs should be decommissioned or reduced as a consequence of new and improved practice or medicines being introduced.

Achieving change will be slow – however, a few high-impact innovations are identified to kick-start this process. Most of these interventions are technologies, but the management of dementia in accordance with NICESCIE guidelines is highlighted.

From 2013, compliance with high impact innovations will be incorporated into the CQUIN requirements.

5. Procurement

Procurement processes will be smartened up, beginning with a procurement strategy that will be produced shortly to enable delivery of about £1.2bn of the £20bn savings required of the NHS. Among other priorities, there will be a focus on innovation and the emphasis will be on building partnerships with industry that deliver mutual value rather than just transactions.

6. Education and leadership

Innovation will be established as an integral part of clinical and managerial education, training programmes, continuous professional development and competency frameworks in the NHS.

A jointly funded industry and NHS training and education programme will be established to enable senior NHS managers and clinicians to work and train with their industry counterparts, together with a new industry and NHS CEO network.

An NHS Innovation Fellowship Scheme, drawing experts from different sectors including industry, will provide coaching and mentoring for senior NHS staff, conduct master classes and provide advice and support on innovation strategies.

An Innovation Pipeline Project to accelerate the adoption and dissemination of proven interventions will be established by the ABPI, the ABHI and the NHS Confederation. Between 15 and 20 joint working projects will be up and running by December 2013.

Chief executives of Clinical Commissioning Groups (CCGs) and the NHS Commissioning Board will be personally responsible for ensuring that research, innovation and adoption are taken up and are part of commissioning plans. This will be reinforced by a statutory duty on CCGs to seek out and adopt best practice.

What’s new for pharma?

Although much of the Innovation document is focused on medical technologies, there are a few key actions for the pharmaceutical industry.

A few more details are still required, but the action is starting now, with NHS commissioners prioritising the adoption and spread of innovation and good practice using the CQUIN mechanism of payment.

­The Government appears quite serious about forging closer links with the industry through joint training and joint working projects with the NHS, and this is a good a time as any to take the initiative.

At all levels pharma has an opportunity to engage with NHS colleagues to demonstrate how their products could streamline care and improve efficiency. The breaking down of budgetary barriers will make it easier to develop a business case, for example, for a particular medicine in primary care reducing the need for a service or intervention in secondary care.

For the first time, encouraging innovation will be put on a statutory footing for commissioners, and this will develop further as commissioning for outcomes becomes the norm. Another opportunity presents itself for the industry to put forward the argument that their products can improve outcomes, and to provide examples of excellence using the local best practice tariffs.

One greatly encouraging feature is the attention given to raising awareness of innovations among patients and the public. They can be the best advocates for the uptake of new interventions, and perhaps will be more willing to support research undertaken by the industry by getting involved in clinical trials.

This document provides the best direction so far on how the NHS and the pharmaceutical industry can work together for mutual benefit.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.

European regulators, including representatives of the EMA and the MHRA, have called for open access to clinical trial data.

Writing in the journal PLoS Medicine, the authors pointed to confusion over the clinical value of Roche’s Tamiflu as a key example of poor access to trial data.

The articles accused Roche of exploiting ‘swine flu’ panic in order to gain major sales contracts on the basis of marketing claims not backed up with evidence.

The treatment of clinical trial data as commercially confidential, the articles said, can lead to major public health decisions being manipulated by drug companies.

An article in the journal by Peter Doshi and others argued that concerns over the use of Tamiflu justified a call for better sharing of clinical trial data.

In response, an article by European regulators, including the EMA’s Executive Director Guido Rasi and Senior Medical Officer Hans-Georg Eichler as well as MHRA’s Alasdair Breckenridge, argued that clinical trial data should be made available for independent analysis and the development of public health policy.

Doshi et al noted that the EMA and the US Centers for Disease Control and Prevention both asserted Tamiflu to be effective in reducing complications in people with influenza, whereas the FDA required a statement in the drug’s label that it had not been shown to do so.

The organisations based their views on a meta-analysis of ten clinical trials involving Tamiflu published in 2003 – apart from the FDA, which used data from the trials themselves.

As a result, Tamiflu supplies were stockpiled in many countries, but their clinical value is still contested.

Using freedom of information requests, Doshi et al obtained additional sections of the clinical study reports for Tamiflu. The article claimed that Roche refused to provide the additional data for the meta-analysis, and that their reasons “kept changing, and none seemed credible”.

Eichler et al agreed that clinical trial data should not be considered commercially confidential. They suggested that patient confidentiality could be protected by the development of new standards, and also recommended the adoption of quality standards for meta-analyses.

“We welcome debate on these issues and remain confident that satisfactory solutions can be found to make complete trials data available in a way that will be in the best interest of public health,” the authors concluded.

The British Generic Manufacturers Association (BGMA) has partnered with the MHRA to develop a more efficient way to communicate drug safety information.

The project co-ordinated safety information for a generic diabetes drug from 12 manufacturers, with the regulatory body approving the material.

With generic drugs becoming more prevalent in the UK market, the new system promises to simplify the approval and distribution of safety information in the NHS.

New drug safety information currently needs to be sent by each manufacturer to all healthcare professionals including GPs, nurses and pharmacists.

In the new project, the BGMA centrally co-ordinated information on behalf of 12 generic drug companies who were required to communicate information for the diabetes drug pioglitazone.

The shared safety information was approved by the MHRA and then sent to healthcare professionals. Thus the regulator and the clinicians were able to deal with a single set of information rather than 12 sets.

Michael Cann, Chairman of BGMA, said: “This project is a great example of how partnerships between the regulator and provider companies can be very effective in driving through a more streamlined, clearer process, which ultimately is good news for patients.

“We see this as the common-sense first step towards a more improved system which reduces the workload for the regulator and provides healthcare professionals with greater clarity and consistency over important drug safety information.

“In the future we would like to improve the system further through greater use of electronic communication.”

The BGMA represents 22 manufacturers and suppliers of generic medicines that account for around 85% of the UK generics market.