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Well, everyone was waiting with bated breath on the 23rd June when the fate of the UK announced. Though there was almost a surety that the country would vote for stepping out of the EU, a few people had hopes for a miracle.

As the things are clear now, and it is declared that the country is no more a part of the European Union. Though there are several formalities on the way and it will take quite a time to happen actually, people have started thinking about the implications of it on different aspects of life. Right from the term of residence to the price of GBP, and employment policies to clinical trial and drug testing; the decision would affect everything.

Impact on drug trials

Experts say that even if the UK decides to quit the EU by going with Brexit and it invokes the Article 50, there is a cooling period or negotiation period of two years when the EU law will remain effective in the UK, that too after signing off the formal notification.  It means that the sky is not going to fall immediately. According to legal experts, EU Clinical trial will have to be replaced with EU regulation and it can happen between December 2017 and October 2018.

Before Brexit polls, the major pharmaceutical companies in the UK showed their preference towards staying with the EU. They argued that moving out of it will increase the costs of starting and conducting trials. Quite obviously, the clinical trial market in the country will face a massive hit.

Statistics proves that more than 40 percent trails of rare diseases are happening in the European Union, and the UK being part of it reaps great benefits. However, in the changed scenario, the country will lose out many of the trials. It is not a great thing from the point of view of patients. In fact, many research institutes have already informed that the trials will not take place in the UK if it exits from the EU.

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Brexit is good for the country, some experts think

People who are on for Brexit also have some rationale. They feel that the EU Clinical Trial Directive (popularly known as CTD) has made the process hundred times complicated than earlier. The amount of bureaucracy and complexities in the application procedure makes it incredibly difficult. They come with data points which state that the number of the clinical trials pre-CTD era was almost double as compared to the post-CTD times.

Some experts feel that Brexit will speed up the availability of drugs in the country which is beneficial for the patients. As of now, many companies follow the path of getting approval from the European Medicines Agency or EMA.

It is a kind of blanket approval to sell or market medicines across all countries of the EU.  Medicines for rare types of cancer or other diseases follow the route. However, slow speed and complicated procedures are the biggest roadblocks felt by pharmaceutical companies.

Some experts tend to differ

Some People fear that Brexit will greatly impact the clinical research from the regulatory angle as well. Tomorrow, when the UK will be forced to give application for clinical trials out of the EU countries, there will be a drastic drop in the clinical research and patient access.

Today, the headquarters of EMA is in London. With the UK getting out of the EU, it has to be moved out of London. It will be placed in any of the EU member countries. It will reduce the importance of the UK in the world of pharmaceuticals and medicines. If the UK decides to be the part of EEA in spite of moving out of the EU, then there will be a status-quo. I case it decides otherwise, then the route of EEA won’t be applicable.

Post-Brexit scenario in brief

  • The UK will establish altogether new legislation, or it will be forced to transpose the same to the Scottish, Irish or Welsh laws.
  • EMA will most probably move the headquarters to any of the countries of the EU from London.
  • There is a need for special arrangements for clinical trials in the UK. Pharmaceutical companies are supposed to sign a separate agreement for it. Experts fear that a great load of paperwork will be there initially.
  • The process of batch release will also become further complicated. The UK authority will not be able to give a blanket approval. Thus, the process of manufacturing, storing and distributing medicines will become more complex as compared to today.
  • EMA centralize authorization process will no longer benefit the UK. Every new medicinal product has to be authorized and approved by MHRA (the regulatory agency of the UK).
  • If the UK decides not to leave the European Economic Area or EEA, then clinical trials and authorization of new drugs will have a minimal impact. Also, the country will continue to enjoy the paybacks of the synchronized regulatory framework.

Conclusion

As the cliché goes, “a coin has two sides’; there are pros and cons of Brexit from the economic point of view. It is a fact that the decision is a big one, and it is not possible to pass judgment based on a single aspect. As far as the impact on clinical trials is concerned, there are mixed opinions. Some experts feel that it will be a major setback for the UK because not many drug trials will take place in the country. Certainly, it is disheartening news for patients suffering from rare diseases. Since the companies will prefer other countries of the EU, it is quite obvious that the patients of the respective countries will get benefited.

At the same time, some experts feel that it will give a sigh of relief to the pharmaceutical companies that get fed up with the slow approval process and bureaucracy of EMA. As per them, taking approval of MHRA will be quite easy.

Since it will take at least two years to see the actual effects on the ground, people want to follow the  “wait and watch” strategy.

 

The ‘Make in India’ campaign by Prime Minister Narendra Modi has 25 sectors in focus including Pharmaceuticals and Chemical sector. This may proven to be a booster dose to the Pharmaceutical Manufacturing Industry.

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The Make India campaign will result in attracting investment from foreign markets. The government has already created a dedicated online cell to answer queries from all over the globe. Primarily, the ‘Make In India’ focuses on zero defect and zero effect. In which zero defect means products which are manufactured in India should not be rejected in the overseas market. Zero effect means that the manufacturing should not have any negative impact on the environment. Continue reading

The EU India FTA dispute has been resolved

The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.

The World Trade Organization dispute was initiated by India and supported by Brazil. The EU made the seizures on grounds of patent infringement, but India and Brazil disagreed with those claims. As a result of India and Brazil’s concerns, the EU is examining its rules that triggered the disputes. By amending customs codes the EU plans to stop the seizure of generic drugs passing through European ports en route to Latin America and Africa. In the past shipments of drugs, legal in the exporting and importing countries, were stopped because they were not recognized in the EU. Transports in transit will no longer be checked, except for counterfeiting.

Current Scenario

An EU-India summit in Brussels, Belgium, in December 2010 has strengthened the strategic partnership between the regions and furthered free trade agreement (FTA) negotiations. Over the last seven years, bilateral trade has already doubled. A stronger partnership between the world’s biggest political Union of 27 democracies—the EU and the biggest democracy in the world—India, will be welcomed, not only for its economic potential, but also its huge political potential.

A Promising Prediction/Forecast

In January 2011, consultants Fitch Ratings said ‘the outlook for Indian generic pharmaceuticals for 2011 is stable. Earnings and profitability of Indian generic-based pharmaceutical companies will benefit from continued demand for generics. Fitch expects the US market to be the main growth driver for the demand of generics, while the Indian domestic market will continue to remain buoyant. There is a good possibility of further interest in partnerships between global innovator and Indian generics companies.

India and the European Union (EU) seem to have finally buried the hatchet regarding the quandary surrounding the agreement on the Trade-Related Aspect of Intellectual Property (TRIPS), which had raised widespread concerns on India’s ability to export generic drugs to the poorer countries and its credibility as the ‘pharmacy to the world’.

Both sides are learned to have reached the consensus during Commerce and Industry Minister Anand Sharma’s visit to Brussels last month to meet EU Trade Commissioner Karel de Gucht, where the issue was discussed at length behind closed doors.

Earlier this year, India filed a complaint against EU at the World Trade Organization’s (WTO’s) disputes panel but both sides were asked to resolve the matter bilaterally with the help of consultation process. While EU has agreed to India’s stand, it remains to be seen what impact it would have on the dispute particularly as it is now a commercial dispute concerning the customs.
EU is yet to officially announce the decision even as Prime Minister Manmohan Singh visits Brussels for a summit with the 27-nation bloc on December 10. Minister Sharma and Commerce Secretary Rahul Khullar will also accompany him. During the visit, a report on the progress made so far on the broad-based India-EU FTA is expected to be released.

“EU-India deal could threaten access to essential HIV drugs.

As Indian and European officials meet in Brussels to thrash out the details of a Free Trade Agreement (FTA), civil society activists are concerned the deal could mean tighter intellectual property protections that could reduce access to cheap Indian generic drugs.

“”The European Union is pushing for data exclusivity, which means Indian generics manufacturers would no longer be able to use existing studies to make identical drugs, a practice recommended by WHO [UN World health Organization] – they would have to conduct their own clinical trials, which would be unethical and redundant since we already have evidence that the drug works, but also, the data exclusivity could last anywhere between five and 10 years, delaying poor countries’ access to these drugs for long periods,”” Michelle Childs, director of policy and advocacy for Médecins Sans Frontières’ campaign for access to essential medicines, told IRIN/PlusNews.

More than 80 percent of all donor-funded antiretroviral drugs used in developing countries are Indian generics; the availability of cheap ARVs has enabled more than five million people globally to access essential HIV treatment. Until 2005, the country did not grant patents on medicines, but World Trade Organization (WTO) rules now require India to grant patents. Indian law only grants patents on drugs that show a therapeutic benefit over existing ones; activists fear that trade agreements like the EU-India one could override these public health concerns.

According to a 2010 study published in the Journal of the International AIDS Society this year, “”future scale-up using newly recommended ARVs will likely be hampered until Indian generic producers can provide the dramatic price reductions and improved formulations observed in the past””. The authors recommend that rather than agreeing to inappropriate intellectual property obligations through FTAs, India and its trade partners “”should ensure that there is sufficient policy space for Indian pharmaceutical manufacturers to continue their central role in supplying developing countries with low-priced, quality-assured generic medicines””. ”

EU and India are in talks on a free trade agreement that they hope could be completed in October this year.
If the agreement takes its final shape, prices of medicines in India would go up because the bilateral deal would tighten the protection of intellectual property rights of drug-makers and require the manufacturers of generic drugs to make their own drug tests instead of relying on data from the original pharmaceutical firms.
EU Trade Commissioner Karel De Gucht said the EU had agreed to make changes to the deal and that developing countries had the right to access essential medicines. The European Commission is going to take care that there are no hindrances for access to essential medicines for people from a developing country.