Healthcare newsletter - Clyde & Co · MENA Healthcare newsletter Pharmaceutical edition October...

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Message from the Editor The pharmaceutical sector in the MENA region is continuing to grow rapidly on the back of mandatory health insurance schemes, growing populations and an increase in lifestyle diseases. GCC governments are implementing strategies and policies to reduce healthcare expenditure including the amounts that they spend on pharmaceuticals. For example, certain governments (who have historically generally purchased branded medicines) are implementing policies which encourage the prescription of generic medicines over branded drugs, where possible. In addition, governments are regulating the profit margins of importers, distributors and pharmacies with regard to the sale of imported pharmaceuticals (which allow the governments to control the final price of such pharmaceuticals). GCC governments appear to also be encouraging the establishment of more local drug manufacturing facilities to reduce the region’s reliance on expensive imports. Notwithstanding these government initiatives, the process for establishing new drug manufacturing and distribution facilities in this region can still be a relatively protracted process. As a result, foreign pharmaceutical companies often choose alternative options for expanding their respective businesses in the Middle East. We are seeing an increase in tie ups between foreign pharmaceutical companies and local manufacturers / distributors. These tie ups are being structured in a number of different ways including foreign investment in local companies, joint ventures, toll manufacturing arrangements, licensing agreements and distribution agreements. High profile examples of such tie ups include Sanofi’s investment in Globalpharma, Neopharma’s manufacturing arrangements with Pfizer and Julphar’s licensing agreement with Merck. Clyde & Co’s healthcare group can assist with the legal aspects of establishing a local drug manufacturing facility in the region and can also advise on the commercial arrangements referred to above. We have a well-informed team that is very experienced in dealing with the specific legal issues that need to be considered and addressed in relation to each of these arrangements. The articles in this newsletter touch upon some of the issues that are currently being faced by the pharmaceutical industry. We would be delighted to discuss any of these issues with you in greater detail. MENA Healthcare newsletter Pharmaceutical edition October 2016 ‘Clyde & Co has sterling experience in the healthcare industry where it acts for many leading names. Chambers Global 2016 Barton Hoggard Lead Partner, Healthcare D: +971 4 384 4370 E: [email protected] In this issue we cover: Market updates and insights Code of Conduct for UAE Pharmaceutical Professionals: Implications for Employers & Operations “Beyond Oil”: the pharmaceutical industry in the UAE Distribution of pharmaceutical products through a local partner in the GCC Pricing of Pharmaceuticals Products in the United Arab Emirates Promoting Life Sciences in Qatar 1 2 3 4 5 6

Transcript of Healthcare newsletter - Clyde & Co · MENA Healthcare newsletter Pharmaceutical edition October...

Message from the EditorThe pharmaceutical sector in the MENA region is continuing to grow rapidly on the back of mandatory health insurance schemes, growing populations and an increase in lifestyle diseases.GCC governments are implementing strategies and policies to reduce healthcare expenditure including the amounts that they spend on pharmaceuticals. For example, certain governments (who have historically generally purchased branded medicines) are implementing policies which encourage the prescription of generic medicines over branded drugs, where possible.

In addition, governments are regulating the profit margins of importers, distributors and pharmacies with regard to the sale of imported pharmaceuticals (which allow the governments to control the final price of such pharmaceuticals).

GCC governments appear to also be encouraging the establishment of more local drug manufacturing facilities to reduce the region’s reliance on expensive imports.

Notwithstanding these government initiatives, the process for establishing new drug manufacturing and distribution facilities in this region can still be a relatively protracted process. As a result, foreign pharmaceutical companies often choose alternative options for expanding their respective businesses in the Middle East.

We are seeing an increase in tie ups between foreign pharmaceutical companies and local manufacturers / distributors. These tie ups are being structured in a number of different ways including foreign investment in local companies, joint ventures, toll manufacturing arrangements, licensing agreements and distribution agreements.

High profile examples of such tie ups include Sanofi’s investment in Globalpharma, Neopharma’s manufacturing arrangements with Pfizer and Julphar’s licensing agreement with Merck.

Clyde & Co’s healthcare group can assist with the legal aspects of establishing a local drug manufacturing facility in the region and can also advise on the commercial arrangements referred to above. We have a well-informed team that is very experienced in dealing with the specific legal issues that need to be considered and addressed in relation to each of these arrangements.

The articles in this newsletter touch upon some of the issues that are currently being faced by the pharmaceutical industry. We would be delighted to discuss any of these issues with you in greater detail.

MENA

Healthcare newsletterPharmaceutical editionOctober 2016

‘Clyde & Co has sterling experience in the healthcare industry where it acts for many leading names.Chambers Global 2016

Barton HoggardLead Partner, Healthcare D: +971 4 384 4370 E: [email protected]

In this issue we cover:

Market updates and insights

Code of Conduct for UAE Pharmaceutical Professionals: Implications for Employers & Operations

“Beyond Oil”: the pharmaceutical industry in the UAE

Distribution of pharmaceutical products through a local partner in the GCC

Pricing of Pharmaceuticals Products in the United Arab Emirates

Promoting Life Sciences in Qatar

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Aramex partners with NewBridge PharmaceuticalsAramex has announced its partnership with NewBridge Pharmaceuticals, under which the company is now providing a range of logistics services for NewBridge in the Middle East, Africa, Canada, and the UK. Based in Dubai, NewBridge Pharmaceuticals is a regional specialty company providing a one-stop-solution to pharmaceuticals, biological, genomics, and other innovative healthcare companies.

UAE could be a leader in pharma tech in the regionThe sector is expected to grow globally by a huge amount in the coming years. According to a report by BMI, the life sciences sector is expected to reach Dh69.3 billion by 2019, representing 37 per cent growth from 2014’s Dh50.7bn. In addition, the industry is a hotbed for mergers and acquisitions, as companies look to take advantage of innovative new practices. According to Deloitte, the total deal value of life sciences M&A last year amounted to more than US$520bn, a hefty 47 per cent more than 2014.

UAE pharma firm Julphar posts $36.2m H1 net profitJulphar, the largest Emirati pharmaceutical company, has announced sales revenue of AED759.7 million in the first half of 2016. The company said it posted a gross profit of AED465.7 million while its net profit for the period was AED133.8 million ($36.2 million).

UAE slashes prices on 762 medicinesThe UAE’s Ministry of Health (MoH) has slashed the prices of 762 drugs for a wide range of diseases from between five and 63 per cent. The new prices will be applicable on 657 innovative medicines starting September 1, and 105 medicines starting January 1, 2017.

Life Pharma prepares to make oncology drugs in Abu Dhabi next yearLife Pharma, part of VPS Healthcare, is to start building its Abu Dhabi cancer drug plant. Construction at the Khalifa Industrial Zone Abu Dhabi (Kizad) was supposed to begin last year and it was intended to be operational this year.

Saudi Arabia Pharmaceutical Market to Reach US$ 5.2Bn in 2016The significant rise in lifestyle-related diseases and the developments in healthcare infrastructure are expected to influence the demand for pharmaceuticals in Saudi Arabia. In 2016, the Saudi Arabia pharmaceutical market is anticipated to procure value worth US$ 5,209.5 Mn at a y-o-y growth of 6.0 % over 2015. The mounting demand for branded drug products will continue to incite the growth of the Saudi Arabian pharmaceutical market in 2016.

updatesinsights

Marketand

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A finger on the pulse of A finger on the pulse of

The UAE health sector is an increasingly important part of the UAE economy and its national wellbeing. Whilst servicing a growing population (both foreign and national) the UAE is also becoming a hub for companies’ regional operations as well as a centre for medical tourism.

With the sector being predominantly privatised (underpinned in large part by private medical insurance) a key concern is to regulate the behaviour and service delivery of professionals within the industry. How to balance the business need to operate profitably with the public interest of patient welfare is an issue at the forefront of the Ministry of Health’s strategic vision and regulatory rules. This article is one in a series examining how the Ministry of Health seeks to regulate various professionals whose activities fall within its remit.

The UAE Ministry of Health’s professional code of conduct for the pharmacy profession (the Code) outlines the standard of behaviour expected of licenced pharmacists, and associated staff, in the UAE.

Although the Code is directed towards managing the conduct of pharmacists in the UAE, it indirectly imposes obligations on employers and operations. In addition, a pharmacist’s failure to comply with the standards outlined in the Code may not only directly affect the individual pharmacist but may also have implications for the pharmacist’s employer and/or the operation the pharmacist represents.

Code – Key value principles The Code focuses on three core value principles: competence, respect and integrity. Interestingly, it states that it is not exhaustive and professionals should therefore be alive to their obligations generally.

CompetenceThis principle requires pharmacists to act competently, providing the best level of care possible in a scientific and compassionate way. Under this principle, a competent pharmacist is committed to maintaining his/her competence through lifelong learning and ensuring that he/she receives adequate in-service training for services the relevant pharmacist is required to perform. Pharmacists must be members of a national or internationally recognised pharmaceutical organisation.

Pharmacists also have a duty to review, maintain and improve their knowledge and abilities with the advancement of medical technology and availability of new medicines.

In addition, pharmacists are required to take responsibility for the competency of staff that they directly supervise and competent pharmacists must also have knowledge of first aid.

RespectThis principle provides that a pharmacist’s primary concern must be for his/her patient and other members of the wider community. According to this value principle, pharmacists are required to respect the patient’s culture, race, class or gender, the patient’s right to receive safe medicine, fellow professionals and the pharmacy profession. For example, pharmacists should not supply medicine if there is doubt as to the quality, safety or effectiveness of a medicine.

Pharmacists are also required to have respect for the environment when disposing of unwanted medicine, chemicals and other materials. Given that failure to dispose of such materials in accordance with the prescribed regulatory standards may result in a penalty being imposed on employers, training on the safe and lawful disposal of potentially harmful substances should be provided to pharmacists (and all employees responsible for the disposal of such substances).

IntegrityFinally, pharmacists must be honest and fair in all dealings, including not taking advantage of their position for personal gain. While the Labour Law governs the employment relationship onshore in the UAE and in Dubai Healthcare City, the law does not impose fiduciary duties on employees. In order to bring the pharmacy profession in line with internationally recognised health care standards and ethics, the Code incorporates a number of obligations on pharmacists to act in good faith and to avoid conflicts of interest in the performance of his/her profession.

ImplicationsEmployers and Operations

Written by Sara Khoja, Partner and Rachael Smith, Associate

for

Code of Conduct for UAE Pharmaceutical Professionals:

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Interestingly, the Code goes further by expressly stating that pharmacists must live according to reasonably expected standards of behaviour both within and outside of their professional practice. Notwithstanding this, employers should take care if electing to implement disciplinary action on the basis of a pharmacist’s conduct outside of work as an employer must have a “valid reason” to terminate an unlimited employment contract under the Labour Law, and a “valid reason” is generally accepted as a performance or misconduct-related reason connected with work.

Under the Code, pharmacists must carry out all responsibilities and duties in a fair and honest manner at all times, ensuring transparency in all financial and contractual matters. This includes not allowing personal benefit to interfere with their professional judgment. Employers should incorporate provisions in pharmacists’ company employment contracts requiring them to disclose any potential conflicts of interest upon commencement of employment and throughout employment. In addition, employers and operations should have clear policies in place documenting how potential conflicts of interest are to be disclosed and handled within the organisation.

Additionally, pharmacists must uphold the confidentiality of patient medical records; subject to the prescribed exceptions (which includes where the patient’s life is at risk, where a court or officer with authority under law demands disclosure, and where the patient or their legal guardian demands disclosure). Pharmacists should be made aware that unlawful disclosure of medical records may constitute a criminal offence under the UAE Penal Code (as it is a criminal offence to infringe an individual’s privacy, as well as to publish/disclose personal or sensitive personal data to third parties). Given the importance of maintaining confidentiality of patient records, this should be reflected in the pharmacists’ employment contract.

Sale of DrugsPharmacists and medical professionals (nurses, doctors and other practitioners) also need to be alive to their duties with regard to the sale and prescription of drugs. A common practice within the industry is for sales staff to be incentivised by the volume of deals closed and there is therefore a personal interest in persuading pharmacists and associated staff to purchase and prescribe particular drugs. Article 17 of the UAE Federal Law No 4 of 1983 concerning the pharmaceutical profession and institutions (as amended) prohibits pharmacists from encouraging patients to buy medicines through secret deals with others. Offering an incentive to a pharmacist or associated staff to prescribe drugs or promote certain drugs is unlikely to be ethical and it should be noted that bribing (which can be widely defined) a public official or individual carrying out a public function can amount to a criminal offence under the UAE Penal Code. For organisations operating internationally such acts could also fall foul of laws with wide scale application, for example the UK Bribery Act.

Practical TipsOrganisations employing or engaging pharmacists and associated staff should ensure that they are doing the following:

a) Providing a training programme to ensure the pharmacist is up to date with industry knowledge;

b) Ensure that employment contracts are properly drafted to include fiduciary duties and contractual obligations to comply with the Code;

c) Ensure that job descriptions and employment contracts adequately define the supervisory role of the pharmacist; and

d) Ensure that codes of conduct and clinical governance procedures are in place, and regularly reviewed and notified to staff.

A finger on the pulse of

Sara KhojaPartner E: [email protected]

Rachael SmithAssociate E: [email protected]

For more information, please contact:

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A finger on the pulse of

Mr Amin Al Amiri, the assistant undersecretary of Public Health Policy and Licensing at the UAE Ministry of Health has recently indicated that this expansion will be unhindered by oil prices because the economy relies on many other things “beyond oil”. The UAE’s health budget is expected to be increased from AED10.32 billion in 2015 to AED13.97 billion in 2019.

This increased focus on the development of the pharmaceutical industry has motivated and encouraged certain international companies to become more involved in the UAE pharmaceutical industry. Some are looking to start obtaining the necessary approvals from the relevant regulators to establish R&D laboratories or manufacturing plants in the UAE.

Currently in Dubai, free zones appear to be the favourite location for opening manufacturing facilities, with free zones such as the Dubai Science Park being set up with a specific focus on biotechnology and research (among other things such as renewable energy). They provide the opportunity to establish a presence with flexible ownership structures allowing up to 100% foreign ownership, with potential tax benefits. Companies such as Bristol-Myers, Pfizer and Amgen have all opened there.

If companies are interested in carrying out medicine manufacturing activities outside the free zones, i.e. ‘onshore’ in the UAE, they would need to obtain a licence from the Economic Development Department in the relevant Emirate, as well as the UAE Ministry of Health. In the Emirate of Dubai, the approval of Dubai Municipality would also be required. At the time being, a company looking to carry out any activities related to the manufacture or sale of pharmaceuticals ‘onshore’ in the UAE must be set-up as a limited liability company or a sole establishment.

Companies wishing to set up as pharmacies will, in addition to a licence from the relevant Economic Development Department, need to obtain the approval of the Dubai Health Authority (DHA) in the Emirate of Dubai, or the Health Authority in Abu Dhabi (HAAD) in the Emirate of Abu Dhabi.

Although companies have reported that the lack of local talent is a large barrier leading to increased manufacturing costs, some international pharmaceutical companies appear to have combated this by pairing up with existing local manufacturers who already have the infrastructure and personnel on the ground. These partnerships can take the form of a joint venture or a contractual partnership arrangement.

Regardless of their methods of entry, pharmaceutical companies are continuing to enter the UAE to cement themselves in a leading pharmaceuticals hub of the GCC and wider geographical region.

Naji HawayekPartner E: [email protected]

Munisha KhatwaniSenior Associate E: munisha.khatwani @clydeco.com

Sirena ChalhoubTrainee Solicitor E: [email protected]

For more information, please contact:

“Beyond oil”pharmaceutical industry

With the number of pharmaceutical manufacturing plants expected to double in the UAE in the next five years, a number of major players in the international and regional pharmaceutical industry are looking to the UAE as a potential market and a regional base to support their operations elsewhere in the Middle East, Africa and South Asia.

the

Written by Naji Hawayek, Munisha Khatwani and Sirena Chalhoub

in the UAE

A finger on the pulse of A finger on the pulse of

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Distribution of

through apharmaceutical products

local partner in the GCC

This growth has been driven by the expanding middle class (which has more income to spend on non-prescription healthcare products) and the continued importance placed by local governments on well-funded healthcare programs. This growth is also partly driven by the use of the GCC region as a base for expansion into nearby developing markets such as Africa and this is particularly true of manufacturers of generic drugs.

The rapid economic development in the region has also given rise to related diseases such as obesity, diabetes and cardiovascular disease. The region has a high prevalence for rare and genetic diseases. Whilst this has a negative impact on the countries and populations affected, both of these factors give the pharmaceutical industry further opportunities to grow. Despite this stellar growth, low oil prices have and will inevitably continue to affect government healthcare budgets and private healthcare programmes meaning that large price reductions across multiple therapeutic areas are to be expected. Added to this is the fact that the regulatory authorities are continuing to become more sophisticated and likely to continue to expand the regulatory regime for healthcare products.

Despite these uncertainties, the GCC continues to offer exciting opportunities for the pharmaceutical industry. In this article, we set out some of the key considerations for companies looking to expand into the region with a focus

on manufacturers of pharmaceutical products who do not have a legal presence in the GCC.

Commercial Agency LawsIn general, an overseas manufacturer wishing to import pharmaceutical products into a GCC country must either have a legal presence in the relevant territory or must appoint a local agent or distributor which is approved by the regulatory authorities to import pharmaceutical products into the territory on behalf of the manufacturer.

Many of the jurisdictions across the MENA region have specific laws which give registered commercial agents certain rights as set out in those laws, the most important of which tends to be the agent’s right to compensation on termination of the relationship with their principal. In general, these commercial agency laws only apply when the agent is appointed on an exclusive basis. It is not uncommon for distributors of pharmaceutical products to claim that they must be appointed on an exclusive basis in order to comply with local pharmacovigilance requirements. If this is true, the distributor could seek to register the distribution agreement with the authorities and thereby gain rights under the relevant commercial agency law.

Using the UAE as an example, the UAE commercial agencies law will only apply if the agency agreement between the agent and principal is registered in the Ministry of Economy’s commercial

agencies register. In order for an agency agreement to be registered with the Ministry, it must meet the minimum qualifying criteria being:

• theagentmustbeaUAEnationalor an entity that is wholly owned by UAE nationals;

• theagreementmustgrantexclusivity over all or a part of the UAE;

• theagreementmustbenotarisedand attested by a notary public in the jurisdiction in which it is signed and authenticated for use in the UAE; and

• theagreementmustbeinArabic,orin dual language form (e.g. English and Arabic).

Principals should note that, in the UAE, a registered commercial agent can prevent the principal’s products from being distributed in the territory for which they have exclusive rights.

Marketing AuthorisationsAs in other jurisdictions, it is not possible to place a pharmaceutical product on the market without first having registered that product with the relevant authorities (subject to limited exceptions which we do not explore further in this article).

In the UAE for example, the application must be prepared and submitted in the joint names of the manufacturer who holds a marketing authorisation

The pharmaceutical and healthcare sector in the GCC region has over the past few years enjoyed one of the most robust growth rates in the world with an average annual growth considerably larger than that of other regions.

Written by Joycia Young and Carl Fennessy

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for the product in its home jurisdiction and the local representative. The local representative can be the distributor of the products as long as: (i) it has the ability to act as the authorised representative in relation to the manufacturer’s obligations and responsibilities; and (ii) it has been appointed by the manufacturer to act as authorised representative. The local representative will be responsible for post-market surveillance of the product and for dealing with the relevant authorities in relation to the product. Alternatively, the manufacturer can appoint a separate local representative under a suitable contract.

The precise paperwork which is to be submitted as part of the application will vary but in general, the documentation to be submitted with the application may include:

• acertificatestatingthattheproducts have been manufactured in conformity with the laws of the country in which they are manufactured;

• a‘freeofsale’certificate;

• acertificatestatingthattheproducts can be manufactured and exported from the manufacturing country;

• documentationrelatingtothesite at which the products are manufactured;

• documentationdetailingtheapproved use of the product;

• documentationdetailingsafeuseand precautions for the products;

• acopyoftheproduct’sinstructionsfor use;

• copiesofthelabellingtobeusedonthe product;

• anauditplan;and

• apharmacovigilanceplanfortheproduct.

Manufacturers should note that the regulatory authorities can ask for additional documentation to be submitted once they begin their review of the application.

Distribution Agreements – Treatment of marketing authorisationsGiven that the distributor acting as a local representative may be required to hold the marketing authorisations in its name, manufacturers should consider how those marketing authorisations will be: (i) transferred to a new distributor; or (ii) deregistered and reregistered in the name of the new distributor on expiry or termination of the underlying agreement.

In some jurisdictions, it may be possible to draft a contract so that the distributor holds the marketing authorisation on trust for the manufacturer. However, this common law concept is not widely recognised in the region.

Alternatively, it may be possible for the distributor to grant the manufacturer’s nominee a power of attorney to transfer/deregister the marketing authorisations on behalf of the distributor. Again, this may not work in all jurisdictions due to restrictions on the granting of powers of attorney.

SummaryObtaining marketing approval to sell pharmaceutical products in the UAE is not dissimilar to the process in other jurisdictions. However, overseas manufacturers who do not have a legal presence in the region should also consider how the commercial agency laws will impact their operations.

A finger on the pulse of A finger on the pulse of

Joycia Young Partner E: [email protected]

Carl FennessyAssociate E: [email protected]

For more information, please contact:

The US, which operates a free-market system in respect of pricing, where the price of pharmaceutical products is determined by the pharmaceutical companies, has come under increased scrutiny, particularly in recent years where the price of pharmaceutical products has risen rapidly. It is a heavily debated topic in the US in respect of which both of the candidates for the upcoming presidential election in the US have raised concerns.

In the UAE, pharmaceutical pricing legislation is in place and provides fixed margins for the distributors and pharmacies in respect of registered pharmaceutical products sold to consumers.

In accordance with Article 65 of UAE Federal Law No. 4 of 1983, all pharmaceutical products imported into the UAE, need to be registered with the Ministry of Health. At the time of being registered, a committee at the Ministry of Health will undertake a review of the pharmaceutical product and then determine the “CIF” price for the particular pharmaceutical product. Pursuant to Incoterms, CIF (cost, insurance and freight) generally means all of the costs incurred to get the relevant product from the place of origin to the named port of destination.

In accordance with Ministerial Resolution (140) of 2013 (the Pricing Resolution), once the CIF price for a pharmaceutical product has been set by the Ministry of Health:

(a) the agent or distributor of the pharmaceutical products (that supplies such products to private hospitals and pharmacies); and

(b) the pharmacy or private hospitals (that then sell the pharmaceutical products to the end consumer),

shall each be paid a fixed margin of the CIF price as set out in the table below. The margin changes in accordance with the 3 CIF pricing categories:

Accordingly, pursuant to the Pricing Resolution, the price of the pharmaceutical product to the end consumer is the CIF price, plus the agent’s margin, plus the pharmacy’s margin.

Previous UAE legislation relating to the pricing of pharmaceutical products made a distinction between pharmaceutical products used for chronic diseases and non-chronic diseases, however, the Pricing Resolution removed

this distinction and applied a single set of margins as detailed above.

The Pricing Resolution applies to both prescription pharmaceutical products and pharmaceutical products which are available over the counter. Certain generic products such as paracetamol and aspirin are products that are not covered under the Pricing Resolution.

The Pricing Resolution applies to the supply of pharmaceutical products to the private sector, including pharmacies and private hospitals. Where drug companies are supplying pharmaceutical products directly to government authorities such as the Dubai Health Authority or to government owned hospitals or to the Abu Dhabi Health Services Company (SEHA), the pricing of pharmaceutical products is not subject to the Pricing Resolution and the price of pharmaceuticals in this instance is determined as set out in the commercial arrangements entered into between the relevant pharmaceutical company and government body or hospital.

It should be noted that the increase in the supply of generic pharmaceutical products in the market place (as a result of the expiry of patents applying to private label products) and the government’s shift to generic medicines (where possible)is also having an impact on the pricing of pharmaceutical products.

In 2011, the UAE government issued a circular which prohibited the discounting of pharmaceutical products or the provision of additional/bonus pharmaceutical products, which could also be interpreted to cover sample products. Whilst this is another example of the government attempting to exerting control over the supply and pricing of pharmaceuticals, there are questions whether, in practice, this circular is strictly adhered to or enforced in the marketplace.

of Pharmaceuticals Products Pricing

in the United Arab Emirates

The pricing of pharmaceutical products is a sensitive issue in which governments across the world adopt varying approaches.

Written by Barton Hoggard and Rajiv Nawbatt

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A finger on the pulse of A finger on the pulse of

Barton Hoggard Partner E: [email protected]

Rajiv NawbattAssociate E: [email protected]

For more information, please contact:CIF Price

(AED 0 – 250)CIF Price

(AED 250 – 500)CIF Price

(above AED 500)

Distributor / Agent 15% 15% 15%

Pharmacy / Private Hospital

28% 28% 20%

Life SciencesWritten by Lee Keane, Partner and Najwan Nayef, Associate

in Qatar

Promoting

Qatar’s strategy for developing its healthcare sector in Qatar includes a commitment to improve the quality and standard of ‘life’ by promoting education and reform in Life Sciences.

In promoting research in Life Sciences, there are a number of existing key players including the following:

• QatarFoundationforEducation,ScienceandCommunity Development (QF) is a private, chartered, nonprofit organization that has, amongst other things, identified research of the Life Sciences as a catalyst for expanding and diversifying Qatar’s economy, enhancing the education of its citizens and increasing the quality of healthcare, wellbeing, and security of its citizens.

• In 2006, QF established the Qatar National Research Fund, as part of it’s ongoing commitment to establish Qatar as a knowledge-based economy, fostering research in, amongst other things, Life Sciences.

• SidraMedicalandResearchCenter is a teaching and research centre that has commenced partial operation this year, and has recently appointed Qatar’s Minister of Public Health, Dr. Hanan Al-Kuwari, to the board of governors for Sidra as a sign of confidence in Sidra and its strategy.

• WorldInnovationSummitforHealth(WISH)isaglobalinitiative of QF with a mandate to inspire healthcare innovation and promote best practices.

In 2015, Hamad bin Khalifa University launched three new postgraduate programs within its College of Science and Engineering to promote education in Life Sciences, namely a masters and PhD program in Biological and Biomedical Sciences, Sustainable Energy, and Sustainable Environment.

Qatar is developing an environment that allows private investment in Life Sciences, as follows:

• TheForeignInvestmentLawallowsforforeignersto apply for an exemption to the requirement that foreigners own no more than forty nine percent

of a limited liability company if the foreigner can demonstrate that the activities it will carry out in Qatar are unique and for the public benefit of Qatar. This exemption is only applicable to certain sectors including the healthcare sector.

• QatarScienceandTechnologyPark(QSTP) is a special free zone which is also a centre of research and commercial excellence for scientific development and regionally produced intellectual property for both Qatari and international partners. The QSTP promotes the research and commercialisation of technology projects and training. QSTP licensed entities are not subject to Qatar tax.

• QatarFinancialCentre,whilstnottraditionallyaplacefor healthcare providers to carry out business in Qatar, has made a strategic decision to diversify from licensing only financial institutions to also license entities involved in other sectors such as healthcare, education and sports. While a company cannot trade in the QFC (ie. sell tangible products) it can set up in the QFC as an unregulated entity to provide advisory and consultancy services. The entities registered within the QFC may operate and trade without a local sponsor or service agent (i.e. 100% non-Qatari ownership is permitted) and are governed by the QFC rules and regulations, including tax and employment regulations.

• ResearchinLifeSciencesisundergoingtremendouschange thanks to advances in high throughput analysis, biomedical engineering, stem cells and gene therapy breakthroughs. The hallmark of the new global research model is collaboration – scientists forming partnerships based on research interests, rather than physical locations. It is a model well-suited to the State of Qatar, which is physically small, but large in talent, ambition, and resources.

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Lee KeanePartner E: [email protected]

Najwan NayefAssociate E: [email protected]

For more information, please contact:

A finger on the pulse of

The need for life sciences research is great. The last few decades have witnessed a rapid increase in the prevalence of chronic and severe diseases, such as diabetes, cancer, and cardiovascular diseases. These diseases, which have devastating health and economic consequences, pose a serious threat to public health in Qatar and throughout the Middle East. The situation calls for urgent preventive and early detection strategies as well as effective therapies.

The Ministry of Public Health has recently confirmed that a new five-year plan will be launched after completion of the current National Health Strategy 2011-2016 demonstrating the Qatari government’s continued focus on achieving its National Vison 2030, and in particular the healthcare sector as a means not only to provide better care and resources to its citizens, but to also diversify its mainly oil dependent economy.

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Commercial Agency – Health Check

www.clydeco.com

Who would benefit from this Health Check?This Health Check has been designed for any company established outside the UAE or in a free zone in the UAE which has appointed a representative in the UAE pursuant to a written agreement.

What does this Health Check include?For a fixed fee of only USD3,500, we will: 1. Carry out a search of the Register of Commercial

Agents maintained by the UAE Ministry of Economy in order to determine whether or not your relationship with your local representative has been registered as a commercial agency agreement;

2. Provide you with a report in which we will:

a. report our findings in respect of item 1 above; and

b. provide a high level preliminary analysis of some of the principal implications of our findings in respect of item 1 above.

ExclusionsThe Commercial Agency Health Check does not include carrying out a detailed review of any agreement that you may have entered into with your representative or any follow up questions or advice.

GCC and wider Middle East regionCommercial agency issues may also arise in each of the other GCC states and wider Middle East region. If your company has appointed a representative in any other GCC state or Middle Eastern country pursuant to a written or oral agreement and you would like advice in relation to the commercial agency issues that may arise from that appointment, please let us know.

Next stepsPlease contact us at [email protected] if you have any questions and/or you would like to benefit from the Commercial Agency Health Check.

www.clydeco.comClyde & Co LLP

CC011062 - September 2016

Clyde & Co* accepts no liability for loss occasioned to any person acting or refraining from acting as a result of material contained in this document. The content of this document does not constitute legal advice and should not be relied upon as such. Advice should be taken about your specific circumstances. No part of this summary may be used, reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, reading or otherwise without the prior permission of Clyde & Co.

*Clyde & Co LLP, Clyde & Co Technical Services JSC and Clyde & Co LLP Lawyers & Legal Consultants.

Clyde & Co LLP is a limited liability partnership registered in England and Wales. Authorised and regulated by the Solicitors Regulation Authority.

© Clyde & Co LLP 2016

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