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We represent the views and interests of our members and industry generally to the UK government, the devolved administrations, regulators, other relevant third stakeholders, including where appropriate the institutions of the European Union.

The BGMA is made up of members of the generic manufacturing industry, who between them account for more than 90% of the total UK market by volume.

A key feature of the strong generics industry in the UK is that it introduces competition to the supply of prescription medicines making drugs more affordable to the NHS and enhancing their availability to patients.

According to the most recent NHS figures around more than a billion items are prescribed generically every year. The increase of generic prescriptions, allied with a reduction in the net ingredients costs, means that overall savings to the NHS medicines bill have now passed more than £13 billion annually.

90%
Total UK market by volume
1bn
Items prescribed generically every year.

Quality forum

The British Generic Manufacturers Association (BGMA) in conjunction with the regulatory body the MHRA, runs a successful forum focusing on ensuring the manufacturing quality of generic medicines in the UK.

The group meets three times a year to share and discuss the latest issues which impact on the quality of generic medicines. The forum brings together generic medicines companies, those who provide manufacturing and quality control services, as well as the MHRA.

Paul Fleming, the BGMA’s Technical Director, said: “As regulatory requirements and supply chains become ever more complex, supporting high quality standards is vitally important for the pharmaceutical industry, patients and the value we deliver to the NHS. From a generic medicines perspective, the forum is an important outlet which is closely aligned with the regulator allowing increased mutual understanding as well as the ability to share the latest information quickly and easily.

“Quality is a key component in ensuring that patients get their medicines in a timely and affordable manner. Our forum  provides a vital conduit between industry and the regulator on a topic which is critically important to the successful operation of the generic medicines marketplace in the UK, Europe and internationally.”

The Quality Forum is open to full and associate members of the BGMA. To find out about joining contact Jeremy Durrant

02078667883

BGMA structure

The BGMA operates through a series of expert working groups that cover Regulatory Affairs, Economic & Commercial (Pricing, Reimbursement, Market Access, etc), Secondary Care, Sustainability, NHS Engagement, Legal Issues and a specialist sector group on Biosimilars via our sister organisation the British Biosimilars Association (BBA www.britishbiosimilars.co.uk). These groups are overseen by the Board.

The working group chairs and vice-chairs are elected by the members of each group and ratified by the Board, which is the Association's decision making body and which meets six times a year.

The working group chairs and vice-chairs report and recommend to the Board, thus ensuring that the Association's policies and activities are member-driven and that all members have an equal input to the decision making.

BGMA executive team

The day-to-day running of the BGMA is headed by Warwick Smith, the association's director general and a secretariat. The BGMA also elects a chairperson and vice-chairperson on a rotational basis drawn from the membership. The current chairman is Peter Ballard and the vice-chair is Thomas Broeer.

Peter Ballard

Chair

Thomas Broeer

Vice Chair

Warwick Smith

Director General

Robert Russell-Pavier

Economics director

Jeremy Durrant

Communications Director

Paul Fleming

Technical Director

Ania Swirski

Regulatory Manager

Sarah Fetherstone Dilke

Economics manager

Peter Ballard

Chair

Peter is the current chair of the British Generic Manufacturers Association and is also the Head of UK for Accord. His first career was in the contact lens industry before he entered the world of generic medicines. Previously to Accord, Peter was Managing Director of Genus which he joined in 2004. Peter has been involved with the BGMA for well over a decade and was involved in the creation of Category M.

Thomas Broeer

Thomas Broeer

Vice Chair

Thomas is the current vice-chair of the British Generic Manufacturers Association. Thomas brings more than 20 years of international pharmaceutical business management experience to the BGMA role working both within the generic and branded industries. Thomas had previously held senior management roles with Kent Pharmaceuticals as well as Mylan in the UK and Germany. He has also worked in South Africa.

Peter BallardWarwick Smith

Warwick Smith

Director General

Warwick Smith is the Director-General of the British Generic Manufacturers Association. He is a member of the Board and Executive of the European Generic medicines Association (EGA), and was one of its Vice Presidents from 1995 to 2000.

During Warwick’s period as Director-General of the BGMA, the Association has negotiated a long term market based reimbursement system for generic medicines giving the industry freedom of pricing and has agreed work sharing schemes with the national regulatory agency (MHRA) to reduce significantly the workload on members. Additionally the association has held joint seminars with the MHRA, successfully countered attacks on biosimilars, is about to agree new arrangements for secondary care contracts and the outsourcing of hospital pharmacies, and has agreed a joint study into the sustainability of the generic industry in the UK with the British Government.

Thomas BroeerRobert Russell-Pavier

Robert Russell-Pavier

Economics director

Robert has worked for the BGMA since 2009. In his current role, Rob initiates and supports the BGMA’s engagement with Government, Parliamentarians, as well as relevant health bodies and other stakeholders, regarding the public reimbursement, pricing and procurement of medicines in both primary and secondary care. Among other areas, Rob is currently focused on helping the Association to articulate its position around the developing homecare market.

Warwick SmithJeremy Durrant

Jeremy Durrant

Communications Director

Jeremy has worked with the BGMA since 2011 and heads up all internal and external communications activity on behalf of the association. He also is actively involved in stakeholder engagement, membership services, events and networking.

Robert Russell-PavierPaul Fleming

Paul Fleming

Technical Director

Paul Fleming is Technical Director of the British Generic Manufacturers Association and prior to that Chair of its Regulatory Working Group for several years. The role includes close and regular discussions with MHRA,  Department of Health, the NHS and other stakeholders.

At a European level, Paul is a key member of the regulatory and quality committees of the European Generic manufacturers Association, EGA. He recently wrote Regulatory Efficiency Report 2015 for EGA, setting out a wide range of recommendations identifying opportunities for improvement within the current regulatory system for generic medicines. In both these roles, Paul is involved in the development, influence and implementation of new regulatory and quality guidance.

Paul  has 15 years’ experience from working in the generic sector of the European pharmaceutical industry, in a variety of senior board level roles covering R&D, drug regulation, pharmacovigilance and clinical development.

Earlier in his career  Paul spent six years with the MHRA as a pharmaceutical assessor and is an appointed expert to the British Pharmacopoeia. He is a registered pharmacist and holds a higher degree in pharmaceutical technology. Throughout his professional life Paul has maintained an involvement with the science of pharmaceutical development connecting  to how medicines can be used for the maximum benefit of patients and the NHS.

Jeremy DurrantAnia Swirski

Ania Swirski

Regulatory Manager

Ania has worked for the BGMA since 2007. In her current role, Ania supports the BGMA’s engagement with the Medicines Healthcare products and Regulatory Agency (MHRA) particularly on collaboration or work sharing schemes which have resulted in efficiency savings and unnecessary duplication for both the membership and the Agency. Ania also supports the Association’s work in the on-going dialogue with the MHRA Board about service delivery and how this can be improved from both the Agency and membership perspective.

Paul FlemingSarah Fetherstone Dilke

Sarah Fetherstone Dilke

Economics manager

Sarah has worked for the BGMA since 2014. In her current role, Sarah supports the BGMA’s engagement with Government, Parliamentarians, and relevant bodies, collating and coordinating Members’ views for submissions. In her role, Sarah focuses on pricing and reimbursement issues, as well as other factors affecting generic medicines suppliers in primary care. 

Ania Swirski

Our members

Accord Healthcare

Aspire

Aristo Pharma Limited

Aurobindo

Bowmed

B Braun

Concordia

Bristol Laboratories

Consilient Health Pharmaceutical

Creo

Dexcel

Dr.Reddy's

Fresenius Kabi

Genesis Pharmaceuticals

Glenmark

Hameln

Kent Pharmaceuticals

Lupin

medac

Morningside Healthcare

MyLan

Niche Generics

Par Pharmaceutical

Rosemont Pharmaceutical

Sandoz

Teva Pharmaceutical

Thornton and Ross

Waymade

Wockhardt

Zentiva

Associate members

Alliance Healthcare

Broughton Laboratories

Celesio

Custom Healthcare

Data Pharm

Day Lewis Pharmacy

FDAS

Medreich

Phoenix Group

WaveData

Woodley Bioreg

Our core focus

Patients

Making medicines more affordable to the NHS and therefore increasing patient access to important, and potentially life-saving, drugs is a key role of the UK generic and biosimilar medicines industry. The NHS faces major funding challenges due to increased demand from an ageing population as well as the rising cost of new technologies and drugs. Generic competition already saves the NHS more than £13bn a year and allows further investment in new drugs which can support unmet patient need.

Case studies

Generic equivalent

Manufacture of Atorvastatin - the generic equivalent of the top-selling global branded drug Lipitor - has saved the National Health Service (NHS) more than £350million in the first 12 months following the expiration of Pfizer’s patent exclusivity last year.

Consistent information

To improve consistent information to patients and significantly reduce the prohibitive cost to the industry and the regulator of each company user-testing every single patient information leaflet (PIL) - at a cost per test in the region of £10,000 - the BGMA co-ordinated user testing of a limited number of typical PILs ensuring that patients received the benefit of common wording for each product irrespective of the manufacturer.

Quality

Generic medicines in the UK must comply with exactly the same standards of quality, safety and efficacy as all medicinal products. They are produced in regularly inspected plants by the UK medicines regulator the MHRA. Just like originator products, once a generic medicine is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported.

Case studies

Quality forum

The BGMA runs a forum in conjunction with the MHRA to focus on issues and guidance relating to quality. The new group meets three times a year to share and discuss the latest information which impacts quality in the generics industry from auditing and inspections through to data integrity and issues surrounding API.

Value

The UK generics industry is the engine room behind a virtuous circle of innovation and cost containment. Each year more than 1billion items are prescribed generically in England and Wales unlocking significant savings for the NHS. As well as delivering cost-savings, generics also provide value through a number of means not least widening accessibility.

Case studies

Innovation

Recently, one of our members developed a liquid version of a product which was previously only available in solid dose. This enabled children and adults with swallowing difficulties (such as following a stroke where there is paralysis of the mouth) to access the drug safely.

New therapeutic entities

Other BGMA members are looking at new therapeutic entities, which are based on the molecule, and formulated, delivered or used in a novel way to meet unmet patient need. These include a new route of delivering a Parkinson’s disease drug, a beta blocker as a once a day glaucoma remedy, and an extended-release once a month and once every three months injection of risperidone (to treat schizophrenia).

Sustainability

The generic industry in the UK is amongst the most efficient in the world with prices currently amongst the lowest in Europe. Competitive prices, and proportionate regulation are required, if the industry is to continue to deliver savings as well as fund the necessary development of the more complex medicines, including biosimilars.

Case studies

Challenges to the industry

The British Generic Manufacturers Association (BGMA) and the Department of Health signed an agreement to work to explore potential challenges to the sustainability of the generic pharmaceutical industry in England.  Based on proposals from the BGMA, the Department will facilitate conversations across government to understand issues and to identify where appropriate action can be taken.

Partnership

The UK generics industry is a key part of an efficient supply chain which ensures patients access the medicines they need in a timely and affordable manner. As part of this manufacturers liaise regularly with Government, regulators and commissioners to ensure product safety, quality and certainty of supply.

Case studies

New product registrations

In the key area of new product registrations, BGMA has been closely surveying MHRA performance year on year and identifying areas requiring improvement, for discussion with the regulator. This has resulted in major improvement in the time taken for new generic medicines to be registered in the UK. This is greatly assisting the predictable timely availability of generic medicines for patients, healthcare professionals and has also resulted in NHS cost savings.

With the increasing weight of new legislation coming from Europe, the BGMA continues to work closely with MHRA to ensure its drafting and UK implementation is well managed, and minimises red tape and over regulation.

Cross-industry group membership

The BGMA is a member of the cross-industry group the NHS Pharmaceutical Sector Board alongside NHS England and the Association of the British Pharmaceutical Industry (ABPI).

Breakthrough project with the MHRA

The BGMA successfully completed a breakthrough project with the MHRA involving 12 separate generic companies which were required to communicate information for the diabetic drug Pioglitazone.

The project saw safety information centrally co-ordinated by the BGMA on behalf of the 12 companies which was then approved by the MHRA and sent to healthcare professionals. This meant the regulator was not required to approve 12 separate applications and those receiving the mailings received one set of consistent, clear information.