Policies & Legislation

Biosimilars bills move on in two US states

The battle over biosimilar drugs is heating up in the US, with two states moving biosimilar bills along in the substitutability of biosimilars.

EU API law causing concern among API producers

Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013, all imported APIs were required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP and as of 2 July 2013 this compliance must be confirmed in writing by the competent authority of the exporting country. Alternatively, the country may request listing (on the ‘white list’) if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.

Tighter EU rules on pharmacovigilance for biologicals

Last updated: 11 March 2013

The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists.

MEPs adopt directive to give quicker access to generics

Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the parliament on 6 February 2013.

FDA gives details of generic drug user fees

FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012 (GDUFA).

India issues more compulsory licences

The Indian Government is once again planning to issue compulsory licences for three patented cancer drugs, allowing local drugmakers to launch generic versions of the drugs before the patents expire on the originator drugs.

India’s patent office at odds with Big Pharma

India and its patent laws are increasingly being challenged by Big Pharma. In its most recent decision, the Indian Patent Office has rejected AstraZeneca’s patent appeal on Iressa (gefitinib). Somewhat controversially the office has been asked by the Supreme Court, however, to reconsider Pfizer’s patent on Sutent (sunitinib). Meanwhile, it is still to issue a final verdict in Novartis’ legal challenge against India’s patent laws.

Generic pre-emption raises its ugly head again

The US Supreme Court is to review a case, which could determine whether generics companies can be held responsible for design flaws in the drugs they copy.

FDA to tighten control over generics

A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking more closely at the techniques generics drugmakers use to make extended-release drugs.

Major shake-up of API import rules in Europe

EU is seeking to impose good manufacturing practice (GMP) standards throughout the world in an attempt to stop the import of counterfeit or substandard active pharmaceutical ingredients (APIs) for human-use medicines. The new rules will come into force next year.

Pharmaceutical trade barriers are falling

The European Parliament has voted in favour of a trade pact between Israel and the European Union (EU) that will allow easier access to medicines from both markets. The EU is also seeking to reduce barriers to other Mediterranean neighbours and Canada.

India patent laws under close scrutiny

The international pharmaceuticals community is watching closely as Pfizer appeals against a decision to revoke its patent on Sutent (sunitinib).

Generic drug user fees come into effect

Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House Energy and Commerce Committee on 21 September 2012. FDA User Fee Corrections Act of 2012 amends the FDA Act to address certain issues raised by language included in the GDUFA.

MSF launches online ‘Patent Opposition Database’

The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing countries challenge unwarranted drug patents.

India plans further cuts to drug prices

The Indian government has announced plans to further extend price cuts on both generic and brand-name drugs in order to try to improve access to affordable medicines in the country.

Generics substitution: Ireland’s plan for reference pricing

A bill that will be debated this autumn seeks to introduce generics substitution and reference pricing for medicines and medical and surgical appliances in Ireland.

India’s patent laws coming under repeated challenges

India’s patent laws are being challenged by Big Pharma. Novartis is challenging India for denying the pharma giant a patent for Glivec (imatinib mesylate), its blockbuster cancer drug. While Bayer is challenging the Indian Government’s decision to grant a compulsory licence on its cancer drug Nexavar (sorafenib).

Malaysia objects to patent terms in free trade agreement

Once again, the issue of patent protection and the periods of exclusivity given to originator pharmaceuticals (both small molecule and biological) has raised its ugly head in the negotiations for the Trans-Pacific Partnership (TPP) Free Trade Agreement. This time, the Malaysian Health Minister, Dr Datuk Seri Liow Tiong Lai, has spoken out against terms in the agreement which seek to extend the patent periods of medicines produced by foreign companies.

Is the end in sight for pay-for-delay?

A Federal appeals court ruling may bring the US pharmaceutical industry before the Supreme Court. Will this put an end to a practice that is increasingly viewed as anticompetitive?

Rising tensions over drug pricing and patenting in India

New developments in pricing and regulations of drugs in India mean that tensions are likely to mount over the coming months between international pharmaceutical interests and healthcare providers who are trying to improve access to affordable medicines.

Australia moves towards pricing policy for biosimilars

The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry of biosimilars into the market place.

India announces free drugs for all―generics only

In a radical move, the Indian government has pledged to provide free drugs for all from October 2012, with a focus on generic medications as a more affordable option than brand-name drugs. The announcement, from Prime Minister Manmohan Singh, follows concerns about rising out-of-pocket expenditure on health care, and the need to contain overall drugs expenditure in India.

Risk management is forgotten as FDA reform struggles through Congress

FDA’s authority on new drug approvals and post-marketing reports was last updated in 2007, when Congress passed the FDA Amendments Act (FDAAA), and this time the deadline is 30 September 2012 for the Prescription Drug User Fee Act (PDUFA), made law in 1992. It is generally accepted that FDA should also amend the Risk Evaluation and Mitigation Strategies or REMS programmes. This is important for generics, since as part of REMS originator companies have to provide samples of their products.

Squabbles continue over Obama health bill

In May and June 2009 the White House reportedly made ‘behind closed doors’ deals with the pharmaceutical industry to win support for the Affordable Care Act. The House Energy and Commerce Committee, which has a Republican majority, released emails from the industry lobbying group. In response, the White House called the release of the emails ‘a nakedly political, taxpayer-funded crusade to hurt the president’s re-election campaign.’

EMA opens up access to reports on suspected drug side effects

In its commitment to transparency, EMA, on 31 May 2012, opened up access to reports on suspected drug side effects. The database contains reports on around 650 medications and active ingredients, including vaccines. Each entry covers a different drug, with aggregated information on suspected but not proven side effects, also known as adverse drug reactions. The database currently holds information on products that have been authorised within the European Economic Area (EEA) via the centralised authorisation procedure which are managed by EMA. Nationally authorised products will feature in a second wave of access in 2013.

US Senator calls for prizes not patents for drug discovery

A radical idea has been proposed by a US Senator calling for patents on drugs to be scrapped and instead an annual prize fund set up, which would reward the discovery of new treatments. These treatments would then, due to competition, become available at the lowest possible price.

Australia cuts prices of 13 more drugs on PBS

Thirteen medicines on the Pharmaceutical Benefits Scheme (PBS), accounting for more than 200 brands, will take price cuts of between 11% and 77% from 1 August 2012 as part of the ongoing price disclosure system agreed between Medicines Australia and the Australian Government.

Bill introduced to allow generics to change labelling

A new bill aims to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs.

PhRMA speaks out against compulsory licensing in India

The decision by the Indian government to issue a compulsory licence for the first time has led the research-based pharmaceutical industry to raise concerns regarding research and innovation.

Obama healthcare budget cuts

US President Barack Obama has announced proposals for fiscal year 2013 which aim to cut the US deficit by US$4 trillion over the next decade. However, drugmakers have reacted with disappointment to proposed cuts to health care.

EMA a step closer to implementing new pharmacovigilance rules

In an attempt to enable better protection of public health, new pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010 [1]. It is now the job of EMA to implement this new legislation, which must be in place by July 2012.

Australia’s biggest-ever generics price cuts coming in April 2012

On 1 April 2012, the prices of 75 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) will be reduced by an average of 28.7%, saving the government an estimated Australian dollars (A$) 1.9 billion (Euros 1.5 billion) over four years.

Landmark EU ruling on supplementary protection certificates

Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease products. It clarifies the scope of protection afforded by supplementary protection certificates (SPCs) and the circumstances under which they can be granted. The ruling answers questions referred by the Court of Appeal of England and Wales in the cases of Medeva (a company bought by Celltech that, in turn, was taken over by Belgium’s UCB in 2004) and Georgetown University, USA.

Twenty per cent of generic drug user fees to come from API manufacturers

In a presentation by the European Fine Chemicals Group (EFCG) at CPhI Worldwide, Frankfurt, Germany, on 25 October 2011, data was presented showing that generic active pharmaceutical ingredient (API) manufacturers are expected to contribute only a small proportion towards generic drug user fees.

FAIR Generics Act could remove 180-day exclusivity

On 16 November 2011, US Senators Mr Jeff Bingaman, Mr David Vitter, Mr Sherrod Brown and Mr Jeff Merkley introduced a bill in the Senate that would remove the 180-day exclusivity period for generics applicants.

Bill to outlaw pay-to-delay moves ahead slowly

A bill banning pay-to-delay, the practice by which originator and generics firms share the profit from drugs coming off patent rather than moving quickly to price reduction, is progressing slowly through the US legislature. It has made its way through the Senate Judiciary Committee but has not yet been approved by the Senate [1]. President Barack Obama has joined in, with a pay-to-delay ban in his 2012 budget proposal [2].

2013’s biggest patent expiries

2013 looks set to be another great year for generics and biosimilars, with once again some major blockbuster drugs losing patent protection.

New stability testing rules for generics

Both EMA and FDA are increasing their requirements for stability testing, especially for generic drugs. These changes could significantly increase the length of time required to gain regulatory approval and increase costs for generics manufacturers to get their drugs onto the market.

Australia and New Zealand outline plans for joint regulatory agency

The Australian and New Zealand governments have agreed to proceed with a joint scheme for regulation of therapeutic goods, i.e. medicines, medical devices, etc. The creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries.

Practical guidance on new pharmacovigilance legislation

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is the regulatory body responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation will be effective from July 2012.

China cuts drug prices for the second time in 2011

China has, for the second time this year, cut the price of drugs. The maximum retail price of 82 different pharmaceutical drug types has been lowered by an average 14% in a move to reduce patient’s medical bills.

US President approves patent reform

On 16 September 2011, US President Barack Obama signed into law a patent-reform bill that has been backed by brand-name drugmakers but opposed by generics companies.

US Senate approves patent reform

On 8 September 2011, the US Senate passed a patent-reform bill that has been backed by brand-name drugmakers but opposed by generic companies.

European Commission publishes new rules on falsified medicines

A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.

Effect of patent filing and initiation of clinical trials on market exclusivity

The effect of the date of patent filing and the initiation of clinical trials can influence the expected duration of marketing exclusivity for originator companies.

Concerns of patent filing and approval date on market exclusivity

An understanding of the relationship between the date of patent filing and the marketing approval date on the expected duration of marketing exclusivity is critical for originator companies to maximise this period of exclusivity in order to recuperate their research and development costs before the advent of generic competition. Recent research has modelled the available duration of US market exclusivity for originator drugs at various times after the initial patent filing [1].

Patent filing and market exclusivity

The relationship between patent filing dates and the marketing authorisation date can change the duration of marketing exclusivity an originator pharmaceutical product can expect to enjoy [1].

Italy and Spain threaten legal action over EU patent

EU ministers have adopted a general approach to the two Commission proposals that provide for a European patent to protect inventions in the same way in all participating member countries. However, Italy and Spain are objecting to the ‘enhanced cooperation’ procedure and threatening legal action.

US caucus to promote generics and biosimilars

Two House members have established a group that they hope will produce legislation that leads to increased use of generic and biosimilar drugs and lower healthcare costs.

UK’s NICE issues first biosimilar recommendation

In a report published in May 2010 the UK’s National Institute for Health and Clinical Excellence (NICE) issued its first biosimilar recommendation, saying the biosimilar somatropin offers the same efficacy and safety as originator somatropins.

US patent reform legislation may delay generics

Generic drugmakers have been dealt a blow in Congress now that the Senate has passed patent-reform legislation despite efforts by the generics industry to remove a provision in the bill.

2012’s biggest patent expiries

Once the patent expiries set for 2011 are gone it is not over for the pharmaceutical industry, as 2012 looks set to be another bumper year for generics, with patents from more of the biggest selling drugs set to expire.

Change in Canadian exclusivity period may harm generics

The EU is in negotiations for a comprehensive economic and trade agreement (CETA) with Canada. As part of these negotiations the EU has proposed changes to the length of data exclusivity for originator drugs in Canada to bring them in line with time periods used in the EU.

2011’s biggest patent expiries

2011 looks set to be a bumper year for generics, with patents from some of the biggest selling drugs set to expire.

Still no word from FDA on generic user fees

Well the FDA finally held its long-awaited meeting on generic user fees on 23 February 2011. However, since then there has been no news from the FDA as to when and how these user fees will be implemented, and more importantly how much they will cost and what will the review timelines be?

European Council gives go-ahead for EU patent – but is it legal

The European Council announced that it had given the go-ahead on 10 March 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.

Falsified medicines law approved by European Parliament

Following many months of negotiations, a new law to prevent fake medicines from entering the supply chain was finally approved by the European Parliament on 16 February 2011. Internet sales will also be covered by the law, which introduces new safety and traceability measures as well as sanctions against counterfeiters. The law, which has been in the pipeline for over two years, still needs to be formally approved by the Council of Ministers.

Negotiations on generic drug user fees

Things seem to be finally moving ahead with the FDA’s long-awaited attempt to create a system of user fees for assessing generic drugs. The US Agency [FDA], which has a backlog of more than 2,000 products to review and has been short of funds for years, will launch negotiations with generic drug manufacturers by the end of February 2011.

Australian copyright law amended to benefit generic medicines

On 22 February 2011 the Australian Senate Legal and Constitutional Committee introduced into Federal Parliament the Therapeutic Goods Legislation Amendment (Copyright) Bill.

More debate over ‘pay-to-delay’ legislation in the US

Two US Senators and now President Barack Obama in his 2012 budget proposal have re-introduced the debate over proposed legislation that would curb—or even ban—‘pay-for-delay’ deals.

Generic pre-emption: what are the implications

Although it has been rejected by several lower courts, generic pre-emption is not yet ‘dead and buried’ as the Supreme Court now takes on the case.

Slow progress towards biosimilar approval in US

Although the Biologics Price Competition Act was passed in 2009, progress has been slow in setting up a route by which companies can apply to license biosimilars in the US.

Exclusivity for biological drugs in the US: what now

Drugmakers have been embroiled in an epic battle over the length of the exclusivity period that biological drugs can enjoy before generic competition. Everyone from legislators to senators to health insurers—and of course both branded and generic manufacturers—has ‘weighed in’ on the debate.

EU patent with 23 countries

The patent deadlock may yet be over, as 23 members of the EU have decided to leave behind the four others and work together to create a single patent system to protect the design of products sold across their borders.

Twelve-year biologicals exclusivity challenged

US Californian Democrat Mr Henry Waxman at the World Generic Medicines Congress Americas 2010 challenged the 12-year exclusivity period for originator biologicals.

Speculation that Hungary will slash drug reimbursement

Hungary will next month announce economic reforms and there are fears that they could include cuts of about 30% to the national drug reimbursement bill. The size of this proposed figure implies massive changes in the Hungarian drug market.

Scottish government considering generic substitution

A Scottish politician revealed on 17 November 2010 that the Scottish government is currently considering whether to introduce generic substitution as part of ongoing efforts to reduce spending over the coming years.

China’s healthcare reform in 2010

In April 2009, the Chinese government announced guidelines for healthcare reform. The main goal was to provide universal health care to the country’s 1.3 billion residents. China planned to invest US$125 billion on health care between 2009 and 2011.

New medicines face big price cuts in Germany

The pharmaceutical industry in Germany is facing price cuts expected to cost the industry more than Euros 2 billion per year, where parliament is set to approve the first price controls on newly approved innovator medicines. The law gives drugmakers one year to agree a price with insurers after new drugs are introduced, but if an agreement is not reached, the German Health Ministry will set maximum pricing and the product will undergo a cost-benefit analysis.

India to delink marketing authorisation and patent status

Marketing approvals for generic drugs may soon be delinked from their patent status in India. This comes as a result of long-standing demand from India’s pharmaceutical industry, which depends heavily on the sale of generic drugs.

Prescription for economic health. Greece acts to reduce expenditure on drugs and counter the culture of corruption

Although its economic situation appeared to stabilise in the spring of 2010, Greece has now dived into the red again. This is the first such development to have occurred so far in the euro zone and reflects the enormous economic upheaval the country is going through. The combination of economic decline and healthcare reforms, particularly to the implementation of large drug price reductions suggest an 8.3% decline in drug expenditure for 2010. The government sees the industry as a politically viable target for cost reductions; the cost of drugs had been pushing up healthcare costs from 2004–2009.

Australian healthcare reform

Australia’s health expenditure totalled Euros 58.6 billion, representing 9.1% of gross domestic product (GDP) in the financial year of 2007–2008, which is the same percentage of GDP as the previous year. Australia’s health expenditure as a proportion of GDP has been comparable to that seen in Europe, with most of its spending coming from the government.

EGA publishes vision for more efficient regulation of generics and biosimilars

On 27 October 2010 the European Generic medicines Association (EGA) published its Vision 2015 following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp, Belgium, 26 October 2010. The EGA is calling for changes in the regulatory requirements for generic and biosimilar medicines ‘for the sake of healthcare sustainability’.

EU patents limp forward

The Belgian EU Presidency is trying to break the deadlock over proposals for a single EU-wide patent system, which has been blocked for over a decade due to language issues.

UK scraps generic substitution plans

The UK government has announced that it will not progress with plans to automatically substitute medications with generic drugs in primary care. Health Minister Lord Howe announced the decision on 14 October 2010, following a public consultation, which showed that many people thought it posed a risk to the safety of patients and could create more work for National Health Service (NHS) staff.

WHO prequalification programme for medicines

Today, one third of the world’s population lacks access to essential medicines. In the poorest parts of Africa and Asia this figure rises to a half of the population.

Price cuts, legislation and reforms

In an effort to reduce budgets governments across the globe are lining up price cuts in prescription medicines, new legislation to control medicine prices and reforms in the healthcare systems. The question is how will all these changes affect the generic medicines industry and is it just a short-term fix?

Pharmacovigilance legislation moves a step closer

In the European Parliament’s plenary session in Strasbourg on 22 September 2010, Members of European Parliaments voted by a huge majority (559 to 7) to adopt new pharmacovigilance legislation. The new EU law should provide better protection for people with medical conditions and make them better informed about the use and any undesirable side effects of medicines.

China set to give a big boost to biologics

According to a report in a Chinese newspaper, China is planning to spend more than CNY 10 billion (US$1.5 billion) to support the development of new drugs between 2011 and 2016. Biotechnology was identified as one of seven emerging industries that China will use to spearhead the next big step in its economic development.

Potential pitfalls in entering China's generics market

China's fast-growing pharmaceuticals market is proving attractive to many foreign pharmaceutical firms, including those in the generics sector. Such companies need to be aware of potential pitfalls, some of which were outlined in Scrip News by Mr Jason Wang, Senior Business Development Manager at GreenPine (Tianjin) Pharmaceutical Co, a company that specialises in the registration and distribution of imported pharmaceuticals in China.