Monthly Archives: July 2016

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.