Outlook 2014: New regulations to affect the pharma industry
It is crucial that professionals working in the pharmaceutical industry stay up to date with new laws and directives.
With the outlook for the global economy being much brighter in 2014, drug developers will be hoping to bring more medicines to market. Although lawmakers have endeavoured to make it easier for companies to complete research and development programmes, a certain amount of red tape remains.
Here are some laws, policies and new guidelines that pharmaceutical specialists should look out for.
Data protection regulations
The consumerisation of technology has heightened concerns about cyber security.
More people are using smartphones and tablets to access the internet and hackers are finding increasingly sophisticated ways to intercept data. The pharmaceutical industry receives and generates huge amounts of sensitive data, so it is crucial that companies follow data protection laws closely.
The EU has announced draft legal reforms aimed at preventing personal patient details from being mishandled. It is unclear at this stage if and when the potential reforms will be made, but governments in some member states have already voiced their concerns.
In the UK, plans had been put in place to create a huge National Health Service (NHS) database containing the records of all patients in England. Unless they opt out, people will have their records anonymised and shared with pharmaceutical firms and researchers.
Healthcare groups believe this will make it easier for medical experts to identify patterns and trends that could hold the key for treating diseases, but data privacy organisations have countered this by suggesting the database breaches people's right to privacy. The proposed EU reforms would render the database illegal.
Social media usage
Social media platforms are becoming increasingly popular, with Facebook boasting nearly 1.2 billion active monthly users.
According to a recent study by IMS Health, nearly half of the 50 leading global pharmaceutical manufacturers are using social networks to engage with patients on health-related topics. Murray Aitken, Executive Director of the IMS Institute for Healthcare Informatics explained that social media use among high-profile pharmaceutical firms is likely to be a growing trend.
"Healthcare professionals, regulators and pharmaceutical manufacturers all need to overcome their reticence and acknowledge the vital role that they can and should play as participants in the healthcare conversation," she commented.
Some pharmaceutical organisations are wary of using platforms like Facebook, Twitter and YouTube because of regulatory uncertainties. However, a number of high-powered industry regulators are using these channels, such as the US Food & Drug Administration and European Medicines Agency. It is worth pharmaceutical industry professionals staying up to date on social media regulatory reforms in the coming years.
A provisional agreement has been reached between the Lithuanian Presidency of the Council of Ministers and the European Parliament relating to new rules on clinical trials.
The Medical and Healthcare Products Regulatory Agency (MHRA) welcomed the news, suggesting the previous directive failed to harmonise requirements across the EU. Leaders at the organisation believe the newly proposed law will make Europe a more attractive place for researchers to conduct medical research.
As part of the reforms, the application process for researchers looking to undertake studies in EU laboratories will be streamlined, member states will have more power over trials that are being carried out across numerous European countries and there will be greater transparency surrounding the results of experiments.
Tighter competition regulations
Concerns have been raised about anti-competitive activity by certain pharmaceutical companies in recent months and this is something that global lawmakers are keen to eradicate.
Regulations are in place to ensure that mergers and acquisitions are not detrimental to competition in the wider industry. Pharmaceutical specialists should monitor the situation closely in the near future, as further reforms are possible. Towards the end of 2013, the European Commission's competition department signed a Memorandum of Understanding to increase cooperation with the Competition Commission of India.
While new legislation has not yet been officially introduced, it is evident the EU is intent on ensuring pharmaceutical firms are following the rules. Joaquin Almunia, Commission Vice President in charge of competition policy, said the agreement "will give new impetus to our cooperation with India in the enforcement of our respective competition laws".
Pharmaceutical companies are more optimistic in 2014, but they cannot afford to concentrate solely on increasing their profits. They must also ensure their organisation is complying with the various laws and guidelines that are likely to take effect this year.