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 generics industry in the UK. Currently, the NHS is facing major funding challenges due to increased demand from an ageing population, rising cost of new technologies and drugs.

Generic competition already saves the NHS £18bn a year and allows further investment in new drugs which can support unmet patient need. We firmly believe there is a moral imperative on all of us in the industry, in the supply chain and the Government to ensure that generics are used to the maximum extent as it ultimately unleashes savings which increases patient access to vital medicines.

To improve consistent information to patients and significantly reduce the prohibitive cost of each company user-testing every single patient information leaflet (PIL) - at a cost per test in the region of £10,000 - Medicines UKS supported co-ordination of user testing of PILs which can be of significant benefit to patients, industry, regulators and the NHS.

Medicines UK has worked extensively with the Medicines and Healthcare products Regulatory Agency (MHRA) and through an innovative implementation plan we have delivered leadership in improving information to patients about their medicines.

Medicines UK members also have a strong commitment to ensuring their packaging meets patient needs and compliance and have been congratulated by the previous National Patient Safety Agency (NPSA) on leading improvements in this area.

Generic manufacturers and suppliers have freedom of pricing in the UK, with the Government relying on competition to keep prices low. The Government only intervenes in pricing if competition can be seen not to be working. The very competitive environment in the UK means that manufacturers' ex-factory prices are amongst the lowest in Europe. We believe that they are now so low that some increases will be necessary to create an economically sustainable market for manufacturers and to ensure that they can sustain the investment needed to produce new more complex generics and more costly biosimilar medicines.

Many European countries determine the cost of their generic medicines through centralised tendering and other centralised mechanisms. However, over a number of years, and particularly around 2002, Medicines UK has worked with UK government to ensure that this has not become the case in the UK. The Association continues to make the case against centralised tendering in primary care. Our competitive system has led to a vibrant multi-source market, minimising the scope for shortages and delivering the lowest market prices in Europe.

The following reports review the generic medicines market in the UK and its contribution to reducing NHS costs. 

OECD - Health at a Glance: Europe 2016 - How does the United Kingdom compare?

In 2016, the OECD published a report (Health at a Glance: Europe 2016) which stated that the development of generic medicines markets across Europe has provided a good opportunity to increase efficiency in pharmaceutical spending. It stated that generics accounted for 84% of the volume of pharmaceuticals sold in the UK in 2014 - the highest among EU countries - but that this represented only around a third of the total market value. The OECD's specific UK findings can be found here. 

NERA - Manufacture, distribution and reimbursement of generic medicines in the UK

A 2001 report conducted by economic consultancy NERA into the manufacture, distribution and reimbursement of generic medicines in the UK reviewed the effectiveness of the freedom of pricing system, as well as alternative pricing and reimbursement systems. NERA's analysis highlighted the benefits of a reimbursement system based on market prices (not list prices) fixed by competition in preference to other alternatives such as tendering, reference pricing, profit controls or direct price controls. Following the report, the Department of Health implemented a reimbursement system based on market prices – which helped realise more savings for the taxpayer and supported widened patient access to medicines. The report can be found here.

When a drug becomes off-patent, competition from generic manufacturers is a very efficient way of driving down prices and increasing savings potential for the NHS as well as delivering innovation through offering competition to patent expired brands. However, there can be a number of barriers which prevent generic competition. As an industry, we face risks to our ability to launch at patent expiry due to activities of the originator sector some of which may be characterised as unfair competition.

We are concerned that the use of patent, or similar extensions of exclusivity, by legislators  to drive industry behaviour can backfire. An example is the so-called "paediatric extension" which grants six months additional exclusivity  in return for carrying out a paediatric investigation plan. These additional periods of exclusivity can cost the NHS enormous amounts of money when the actual number of new beneficiaries may be small in comparison and the research relatively low-cost.

We believe it is morally right that paediatric uses of medicines should be researched and licensed. We do not object to there being a financial incentive, if one is needed, to encourage companies to do this work. However, it just seems that high returns on such comparatively low investment are beyond all reasonable scale and proportionality.

Comparatively high levels of use of generic medicines within the NHS result in very significant savings to the NHS drugs bill. Without those savings, even in normal economic times, the drugs budget could become unsustainable.

Generic prescribing has grown substantially over the past 40 years, from less than one in five prescriptions issued in the mid-1970s to more than 80 per cent in recent years.

Reports by academics, competition authorities, parliaments and independent commentators establish a range of parameters that should be met to support a sustainable generic industry that makes the maximum societal contribution.

These include:

• The long-term sustainability of the generic medicines sector relies on fair prices and a level playing field, particularly in competition with branded medicines, including originators.

• A successful generic medicines policy requires both supply-side measures relating to pricing and reimbursement, and demand side incentives for physicians, pharmacists and patients.

• Significant volumes of generics and multiple suppliers are needed to ensure the maximum benefits for the NHS and patients.

• The generic medicines industry has to compete on a global scale, which includes competition from manufacturers with facilities outside of Europe. This means that it is important that policies encourage manufacture in Europe.

IQVIA data confirms that the average manufacturers selling price in the UK is the lowest in Europe and the US. This in turn benefits the NHS. However in a global market place, pricing needs to be sustainable to support a competitive and healthy supply of generic medicines to the UK in the future. We need to be careful that continuous, increasing pressure on prices in the UK does not reach a tipping point whereby supplying the UK ahead of other international markets may not considered competitive.

The UK's medicines regulator 'the MHRA' rightly has a strong and positive reputation amongst its peers in the EU for its contribution and scientific expertise.

In the key area of new product registrations, Medicines UK 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.

The volume of patent applications has increased substantially in the past decade, with a proportion of those apparently aimed at deterring generic competition. 

Given the volume and unnecessary complexity of some patent clusters - which in certain examples have totalled nearly 1,300 patent applications around a single molecule - it is extremely difficult for generic manufacturers, particularly SMEs, to be confident they would not be in legal breach by launching their product. These practices limit competition and the prospect of lower medicine prices.

We are very concerned that the issue of these type of weak patents - those which don't fully meet accepted criteria - may be aimed at delaying generic competition. 

It is crucial that competition authorities ensure that the operation of markets reverts to what was originally intended: that originators receive long periods of market monopoly on their products during the patent term so that they can recoup their research investment, followed by the immediate onset of generic competition to make medicines affordable and to promote true innovation.

Biological medicines including biosimilar medicines are highly complex, protein based medicines, made or derived from living organisms typically using recombinant DNA technology. Proteins are usually much bigger in size than medicines produced by chemical synthesis and have a higher complexity and variability than small chemical compounds. They can be tailor made so they bind to specific targets in the body.

Biosimilar medicines are biological medicines that have been developed to be highly similar and clinically equivalent to an existing biological medicine and are marketed after the expiry of the patent on the originator or reference biologic.

Biosimilar medicines are comparable to their reference product as they have demonstrated no clinically meaningful differences in safety, efficacy, quality, structural characteristics and biological activity compared to that of the reference biologic.

We work with the NHS to develop guidance that will ensure a more efficient NHS across the UK, whether this is on helping to resolve situations when a supplier is out of stock, or to ensure that all parties are aware of their rights and responsibilities when the NHS is developing new care and pharmacy models.

Standardised management of off-contract claims guidance:

Where a contracted supplier is out of stock and it cannot arrange for an alternative supply to be provided, an NHS trust or health board may charge for the difference between the contract price and what it paid for the replacement stock.

Medicines UK and the ABPI have worked with both the NHS and NHS Scotland to develop practical guidance for English hospital trusts and Scottish boards to help hospitals efficiently make claims when off-patent medicines are out of stock; and for suppliers to process claims efficiently. This saves time and money for both hospitals and suppliers. In some cases, following the guidance may enable medicines to be located in the supply chain so as to resolve out of stock situations. The guidance documents applying to both England and Scotland can be located here: (England) / (Scotland).

Guidance around third party pharmacy provider arrangements:

The Department of Health has issued guidance to NHS trusts about what they need to consider and put in place when establishing and running agreements with third party pharmacy providers to operate hospital outpatient dispensing or homecare services. 
                                  
The DH guidance outlines that NHS trusts must request and receive written permission from contracted suppliers before sharing confidential pricing data with third party pharmacy providers; and that permission should not be assumed. The guidance goes onto list the rights and responsibilities of trusts, third party pharmacy providers and suppliers. This includes third party pharmacy providers separating their hospital and primary care operations and being able to demonstrate this; as well as reporting accurate dispensing data to CMU, thereby supporting future forecasting used for medicines tenders. The DH guidance can be located here.